AzTrials
AzTrials

Childhood Extracranial Germ Cell TumorPhase 3NCT03067181

Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

A Phase 3 study testing Best Practice, Biopsy Procedure and Biospecimen Collection in people with Childhood Extracranial Germ Cell Tumor and Extragonadal Embryonal Carcinoma, run by Children's Oncology Group at 629 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Read more about this study

Who is it for?
Any age
What is being tested?
Best Practice, Biopsy Procedure and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,780 participants
Where
629 sitesin 9 countries
Study dates
25 May 2017to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
  • Standard risk 1: Patients must be < 11 years of age at enrollment
  • Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
  • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).
  • Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:
  • Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided
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  • Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein [AFP- ≥ 500 ng/mL or HCG ≥ 500 IU/L) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently
  • Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor [< 3 mm], but no other pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages
  • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
  • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
  • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11
  • Standard risk 2 (SR2)
  • Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
  • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
  • Notes:
  • IGCCC criteria only apply to SR2 patients with a testicular primary tumor
  • Use post-op tumor marker levels to determine IGCCC risk group
  • Pure seminoma patients are not eligible for the standard risk arms of the study
  • For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
  • Adequate renal function defined as:
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR
  • A serum creatinine based on age/sex as follows (within 7 days prior to enrollment): (mg/dL)
  • 1 month to < 6 months male: 0.4 female: 0.4
  • 6 months to < 1 year male: 0.5 female: 0.5
  • 1 to < 2 years male: 0.6 female: 0.6
  • 2 to < 6 years male: 0.8 female: 0.8
  • 6 to < 10 years male: 1 female: 1
  • 10 to < 13 years male: 1.2 female: 1.2
  • 13 to < 16 years: male: 1.5 female: 1.4
  • >= 16 years male: 1.7 female: 1.4
  • Total bilirubin =< 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
  • Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (within 7 days prior to enrollment)
  • Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
  • Peripheral absolute neutrophil count (ANC) >= 750/mm^3 (within 7 days prior to enrollment) AND
  • Platelet count >= 75,000/mm^3 (within 7 days prior to enrollment)
  • Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
  • Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
  • >= 11 and < 25 years old at enrollment
  • Able to fluently speak and read English
  • Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
  • Followed for cancer or survivorship care at one of the following institutions:
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  • Dana Farber/Harvard Cancer Center
  • Hospital for Sick Children
  • Children's Hospital of Eastern Ontario
  • Oregon Health and Science University
  • Seattle Children's Hospital
  • Yale University

Who cannot join

  • Patients with any diagnoses not listed including:
  • Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
  • Pure ovarian or extragonadal dysgerminoma/seminoma
  • Pure mature teratoma
  • Pure immature teratoma with alpha-fetoprotein (AFP) >= 1000 ng/mL
  • "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or
Show all 15Show fewer
  • Primary central nervous system (CNS) germ cell tumor
  • Germ cell tumor with somatic malignant transformation
  • Spermatocytic seminoma
  • Patients must have had no prior systemic therapy for the current cancer diagnosis
  • Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
  • Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
  • Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])

Trial locations and contacts

629 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

363 sites in 9 countries

United States300 sites, 196 recruiting

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Dan S. Zuckerman

    Recruiting

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

    Active, not recruiting

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

    Site Public Contact, 330-543-3193

    Erin Wright

    Recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Site Public Contact, 518-262-5513

    Lauren R. Weintraub

    Recruiting

  • Presbyterian Hospital

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-559-6113, wburman@phs.org

    Beeling Armijo

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Jessica M. Valdez

    Recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Jacob A. Troutman

    Recruiting

  • Texas Tech University Health Sciences Center-Amarillo

    Amarillo, Texas, 79106

    Active, not recruiting

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

    Active, not recruiting

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Robert M. Cooper

    Recruiting

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Dan S. Zuckerman

    Recruiting

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

    Suspended

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Dan S. Zuckerman

    Recruiting

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Dan S. Zuckerman

    Recruiting

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Dan S. Zuckerman

    Recruiting

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

    Suspended

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Dan S. Zuckerman

    Recruiting

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Dan S. Zuckerman

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125

    Rama Jasty

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Rama Jasty

    Recruiting

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

    Active, not recruiting

  • PCR Oncology

    Arroyo Grande, California, 93420

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Mission Hospital

    Asheville, North Carolina, 28801

    Site Public Contact, 828-213-7055, NCDV.ResearchRegulatory@HCAHealthcare.com

    Douglas J. Scothorn

    Recruiting

  • OhioHealth O'Bleness Hospital

    Athens, Ohio, 45701

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Aine E. Clements

    Recruiting

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia, 30329

    Site Public Contact, 404-785-0232, Olivia.Floyd@choa.org

    Claire Stokes

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Site Public Contact, 706-721-2388, ga_cares@augusta.edu

    Colleen H. McDonough

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Site Public Contact, 303-764-5056, josh.b.gordon@nsmtp.kp.org

    Timothy P. Garrington

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Active, not recruiting

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

    Active, not recruiting

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

    Site Public Contact, 512-628-1902, TXAUS-DL-SFCHemonc.research@ascension.org

    Shannon M. Cohn

    Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Teresa A. York

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Site Public Contact, 410-601-9083

    Jason M. Fixler

    Recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

    Site Public Contact, 410-955-8804, jhcccro@jhmi.edu

    Alan D. Friedman

    Recruiting

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

    Site Public Contact, 207-973-4274

    Daniel L. Callaway

    Recruiting

  • CommonSpirit Saint Joseph Hospital - Bardstown

    Bardstown, Kentucky, 40004

    Active, not recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Overlake Medical Center

    Bellevue, Washington, 98004

    Suspended

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Robert M. Cooper

    Recruiting

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

    Site Public Contact, 360-788-8223, achapman1@peacehealth.org

    Dan S. Zuckerman

    Recruiting

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Saint Charles Health System

    Bend, Oregon, 97701

    Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org

    Dan S. Zuckerman

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Active, not recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

    Site Public Contact, 301-319-2100

    Kip R. Hartman

    Recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Suspended

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

    Site Public Contact, 205-638-9285, oncologyresearch@peds.uab.edu

    Elizabeth D. Alva

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Aniket Saha

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Martha M. Pacheco

    Recruiting

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

    Suspended

  • Tufts Children's Hospital

    Boston, Massachusetts, 02111

    Suspended

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org

    Katina M. Robison

    Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Site Public Contact, 877-726-5130

    A. L. Frazier

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    A. L. Frazier

    Recruiting

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

    Active, not recruiting

  • United Hospital Center

    Bridgeport, West Virginia, 26330

    Suspended

  • Maimonides Medical Center

    Brooklyn, New York, 11219

    Site Public Contact, 718-765-2500

    Mahmut Y. Celiker

    Recruiting

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

    Active, not recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Clare J. Twist

    Recruiting

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

    Site Public Contact, 818-847-4793, Najee.Boucher@providence.org

    Dan S. Zuckerman

    Recruiting

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

    Active, not recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Active, not recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Jessica L. Heath

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 888-446-3729

    Jay W. Carlson

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

    Site Public Contact, 618-457-5200, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • IU Health North Hospital

    Carmel, Indiana, 46032

    Suspended

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

    Active, not recruiting

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

    Active, not recruiting

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • SIH Cancer Institute

    Carterville, Illinois, 62918

    Site Public Contact, 618-985-3333, clinical.research@sih.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Dan S. Zuckerman

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Thomas B. Alexander

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Jacqueline M. Kraveka

    Recruiting

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

    Site Public Contact, 304-388-9944

    Mohamad H. Badawi

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Joel A. Kaplan

    Recruiting

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Holly Edington

    Recruiting

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

    Suspended

  • Southern Oncology Specialists-Charlotte

    Charlotte, North Carolina, 28262

    Suspended

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Brian C. Belyea

    Recruiting

  • T C Thompson Children's Hospital

    Chattanooga, Tennessee, 37403

    Site Public Contact, 423-778-7289

    Benjamin A. Mixon

    Recruiting

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

    Suspended

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

    Site Public Contact, 773-880-4562

    Jennifer L. Reichek

    Recruiting

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

    Suspended

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Suspended

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Dipti S. Dighe

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Susan L. Cohn

    Recruiting

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

    Site Public Contact, 877-779-7585, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

    Active, not recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Site Public Contact, 513-636-2799, cancer@cchmc.org

    Robin E. Norris

    Recruiting

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

    Active, not recruiting

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

    Active, not recruiting

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

    Active, not recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Duncan S. Stearns

    Recruiting

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106

    Site Public Contact, 216-844-5437

    Duncan S. Stearns

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Matteo M. Trucco

    Recruiting

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

    Site Public Contact, 919-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

    Active, not recruiting

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

    Active, not recruiting

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Active, not recruiting

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

    Active, not recruiting

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

    Active, not recruiting

  • University of Missouri Children's Hospital

    Columbia, Missouri, 65212

    Site Public Contact, 573-882-1960, snwq62@health.missouri.edu

    Barbara A. Gruner

    Recruiting

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Stuart L. Cramer

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Site Public Contact, 614-722-6039, Melinda.Triplet@nationwidechildrens.org

    Mark A. Ranalli

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Ahmad Shabsigh

    Recruiting

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Aine E. Clements

    Recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Aine E. Clements

    Recruiting

  • Grant Medical Center

    Columbus, Ohio, 43215

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Aine E. Clements

    Recruiting

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Doctors Hospital

    Columbus, Ohio, 43228

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Aine E. Clements

    Recruiting

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

    Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org

    Dan S. Zuckerman

    Recruiting

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

    Active, not recruiting

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

    Site Public Contact, 361-694-5311, Crystal.DeLosSantos@dchstx.org

    Nkechi I. Mba

    Recruiting

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

    Active, not recruiting

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

    Site Public Contact, 972-566-5588

    Maurizio L. Ghisoli

    Recruiting

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Suspended

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Jonathan E. Wickiser

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Active, not recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Jagadeesh Ramdas

    Recruiting

  • Dayton Children's Hospital

    Dayton, Ohio, 45404

    Site Public Contact, 800-228-4055

    Jordan M. Wright

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Aine E. Clements

    Recruiting

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Aine E. Clements

    Recruiting

  • AdventHealth Porter

    Denver, Colorado, 80210

    Active, not recruiting

  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

    Denver, Colorado, 80218

    Site Public Contact, 303-832-2344, PSGResearchSharedMailbox@HCAHealthcare.com

    Florence Choo

    Recruiting

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-8912, samantha.mallory@unitypoint.org

    Samantha L. Mallory

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

    Suspended

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Roland L. Chu

    Recruiting

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

    Active, not recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Site Public Contact, 815-285-7800

    Bryan A. Faller

    Recruiting

  • Kaiser Permanente Downey Medical Center

    Downey, California, 90242

    Site Public Contact, 626-564-3455

    Robert M. Cooper

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Active, not recruiting

  • Columbus Oncology and Hematology Associates

    Dublin, Ohio, 43016

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Aine E. Clements

    Recruiting

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

    Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com

    Aine E. Clements

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Active, not recruiting

  • CommonSpirit Cancer Center Mercy

    Durango, Colorado, 81301

    Active, not recruiting

  • Mercy Medical Center

    Durango, Colorado, 81301

    Active, not recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Suspended

  • Michigan State University

    East Lansing, Michigan, 48823

    Active, not recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Dan S. Zuckerman

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Active, not recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • El Paso Children's Hospital

    El Paso, Texas, 79905

    Site Public Contact, 915-298-5444, ranjan.bista@ttuhsc.edu

    Benjamin Carcamo

    Recruiting

  • Texas Tech University Health Sciences Center-El Paso

    El Paso, Texas, 79905

    Suspended

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

    Active, not recruiting

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

    Active, not recruiting

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

    Active, not recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

    Site Public Contact, 847-570-2109

    Mary T. Jenkins Vogel

    Recruiting

  • Deaconess Clinic Downtown

    Evansville, Indiana, 47713

    Active, not recruiting

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

    Site Public Contact, 425-261-3529, marilyn.birchman@providence.org

    Dan S. Zuckerman

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Samuel J. Milanovich

    Recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Saint Francis Hospital

    Federal Way, Washington, 98003

    Active, not recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Active, not recruiting

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Robert M. Cooper

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Active, not recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

    Active, not recruiting

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Hector M. Rodriguez-Cortes

    Recruiting

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

    Site Public Contact, 239-343-5333, molly.arnstrom@leehealth.org

    Emad K. Salman

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    Site Public Contact, 682-885-2103, CookChildrensResearch@cookchildrens.org

    Kelly L. Vallance

    Recruiting

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Dan S. Zuckerman

    Recruiting

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Michael Humeniuk

    Recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

    Site Public Contact, 352-273-8010, cancer-center@ufl.edu

    Brian Stover

    Recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

    Suspended

  • Glens Falls Hospital

    Glens Falls, New York, 12801

    Active, not recruiting

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

    Site Public Contact, 847-570-2109

    Mary T. Jenkins Vogel

    Recruiting

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

    Suspended

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

    Site Public Contact, 919-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

    Active, not recruiting

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

    Suspended

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

    Active, not recruiting

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

    John R. Hill, 920-433-8889, Christy.Gilchrist@hshs.org

    John R. Hill

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Catherine A. Long

    Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Catherine A. Long

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Site Public Contact, 252-744-1015, eubankss@ecu.edu

    Andrea R. Whitfield

    Recruiting

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Stephen H. Dyar

    Recruiting

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Aniket Saha

    Recruiting

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Aniket Saha

    Recruiting

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Aniket Saha

    Recruiting

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

    Suspended

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Stephen H. Dyar

    Recruiting

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Aniket Saha

    Recruiting

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Aniket Saha

    Recruiting

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Michael Humeniuk

    Recruiting

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Site Public Contact, 551-996-2897

    Katharine Offer

    Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

    Site Public Contact, 860-545-9981

    Michael S. Isakoff

    Recruiting

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

    Suspended

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

    Suspended

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

    Suspended

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

    Site Public Contact, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033

    Site Public Contact, 717-531-6012

    Lisa M. McGregor

    Recruiting

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

    Site Public Contact, 847-570-2109

    Mary T. Jenkins Vogel

    Recruiting

  • Pulmonary Medicine Center of Chattanooga-Hixson

    Hixson, Tennessee, 37343

    Suspended

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

    Site Public Contact, 954-265-1847, OHR@mhs.net

    Iftikhar Hanif

    Recruiting

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-522-4333

    Wade T. Kyono

    Recruiting

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

    Suspended

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Site Public Contact, 808-983-6090

    Wade T. Kyono

    Recruiting

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

    Active, not recruiting

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

    Suspended

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 713-798-1354, burton@bcm.edu

    Shoba A. Navai

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Najat C. Daw

    Recruiting

  • Novant Health Cancer Institute - Huntersville

    Huntersville, North Carolina, 28078

    Suspended

  • Southern Oncology Specialists-Huntersville

    Huntersville, North Carolina, 28078

    Suspended

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

    Site Public Contact, 304-399-6566, Christina.Cole@chhi.org

    Mark A. Ranalli

    Recruiting

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Active, not recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

    Site Public Contact, 800-248-1199

    Sandeep Batra

    Recruiting

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

    Site Public Contact, 317-338-2194, research@stvincent.org

    Bassem I. Razzouk

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Andrew P. Groves

    Recruiting

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Dan S. Zuckerman

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Site Public Contact, 601-815-6700

    Amanda Strobel

    Recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Vibhuti Agarwal

    Recruiting

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

    Site Public Contact, 910-587-9084, jfields@cancersmoc.com

    Samer S. Kasbari

    Recruiting

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

    Suspended

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    Johnson Creek, Wisconsin, 53038

    Suspended

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

    Site Public Contact, 574-647-7370

    Kathleen Y. Butler

    Recruiting

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

    Site Public Contact, 816-302-6808, COGResearchGroup@cmh.edu

    Keith J. August

    Recruiting

  • Fred and Pamela Buffett Cancer Center - Kearney

    Kearney, Nebraska, 68845

    Suspended

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

    Active, not recruiting

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

    Site Public Contact, 509-783-4637, research@kadlecmed.org

    Dan S. Zuckerman

    Recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916

    Site Public Contact, 865-541-8266

    Susan E. Spiller

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Aditya Bagrodia

    Recruiting

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

    Site Public Contact, 360-412-8958, deidre.dillon@providence.org

    Dan S. Zuckerman

    Recruiting

  • CommonSpirit Saint Anthony Hospital Cancer Center

    Lakewood, Colorado, 80228

    Active, not recruiting

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

    Suspended

  • Saint Clare Hospital

    Lakewood, Washington, 98499

    Active, not recruiting

  • Las Vegas Urology - Pecos

    Las Vegas, Nevada, 89074

    Suspended

  • Desert West Surgery

    Las Vegas, Nevada, 89102

    Suspended

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

    Suspended

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Urology Specialists of Nevada - Central

    Las Vegas, Nevada, 89106

    Site Public Contact, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Site Public Contact, 702-851-4672

    Nicola M. Spirtos

    Recruiting

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Las Vegas Urology - Sunset

    Las Vegas, Nevada, 89113

    Suspended

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89113

    Site Public Contact, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Cancer Therapy and Integrative Medicine

    Las Vegas, Nevada, 89121

    Suspended

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

    Suspended

  • Cancer and Blood Specialists-Tenaya

    Las Vegas, Nevada, 89128

    Suspended

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Las Vegas Urology - Cathedral Rock

    Las Vegas, Nevada, 89128

    Suspended

  • Las Vegas Urology - Smoke Ranch

    Las Vegas, Nevada, 89128

    Suspended

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

    Site Public Contact, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

    Suspended

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • University Cancer Center

    Las Vegas, Nevada, 89169

    Suspended

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89183

    Site Public Contact, 702-384-0013, research@sncrf.org

    Alan K. Ikeda

    Recruiting

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

    Site Public Contact, 877-231-4440

    Laura L. Holman

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Angela Ricci

    Recruiting

  • CommonSpirit Saint Joseph Hospital - Lexington

    Lexington, Kentucky, 40504

    Active, not recruiting

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

    Active, not recruiting

  • CommonSpirit Saint Joseph Medical Center - East Lexington

    Lexington, Kentucky, 40509

    Active, not recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    James T. Badgett

    Recruiting

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

    Site Public Contact, 614-488-2745, Jeffh@columbusccop.org

    Aruna C. Gowda

    Recruiting

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

    Active, not recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

    Site Public Contact, 501-364-7373

    Michael W. Bishop

    Recruiting

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-906-4199, Research@CARTI.com

    Jay W. Carlson

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Active, not recruiting

  • AdventHealth Littleton

    Littleton, Colorado, 80122

    Active, not recruiting

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

    Site Public Contact, 909-558-4050

    Albert Kheradpour

    Recruiting

  • CommonSpirit Saint Joseph Hospital London

    London, Kentucky, 40741

    Active, not recruiting

  • UCHealth Lone Tree Health Center

    Lone Tree, Colorado, 80124

    Active, not recruiting

Other trials in United States

Canada17 sites, 17 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

    Site Public Contact, 403-220-6898, research4kids@ucalgary.ca

    Victor A. Lewis

    Recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

    Site Public Contact, 780-407-8798, pedsoncologyresearch@ahs.ca

    Sarah J. McKillop

    Recruiting

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

    Site Public Contact, 902-470-8520, Research@iwk.nshealth.ca

    Chelsea Ash

    Recruiting

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

    Site Public Contact, 905-521-2100

    Uma H. Athale

    Recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

    Site Public Contact, 613-549-6666, cc-clinicaltrials@kgh.kari.net

    Laura Wheaton

    Recruiting

  • Children's Hospital

    London, Ontario, N6A 5W9

    Site Public Contact, 519-685-8306

    Shayna M. Zelcer

    Recruiting

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, H3H 1P3

    Site Public Contact, 514-412-4445, info@thechildren.com

    Stephanie Mourad

    Recruiting

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Site Public Contact, 514-345-4931, yvan.samson@umontreal.ca

    Monia Marzouki

    Recruiting

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

    Site Public Contact, 613-737-7600

    Donna L. Johnston

    Recruiting

  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

    Québec, G1V 4G2

    Site Public Contact, 418-525-4444, rechclinique@crchudequebec.ulaval.ca

    Bruno Michon

    Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

    Site Public Contact, 819-820-6480, crcinformation.chus@ssss.gouv.qc.ca

    Josee Brossard

    Recruiting

  • Janeway Child Health Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

    Site Public Contact, 709-777-8727, beverlyj.mitchell@easternhealth.ca

    Lisa A. Goodyear

    Recruiting

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Site Public Contact, 416-480-5000

    Allan L. Covens

    Recruiting

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Site Public Contact, 416-813-7654, ask.CRS@sickkids.ca

    Furqan Shaikh

    Recruiting

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

    Site Public Contact, 416-946-4501, clinical.trials@uhn.on.ca

    Robert J. Hamilton

    Recruiting

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

    Site Public Contact, 604-875-2345 ext. 6477

    Rebecca J. Deyell

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Site Public Contact, 866-561-1026, ctu_web@cancercare.mb.ca

    Stephanie M. Villeneuve

    Recruiting

Other trials in Canada

Japan17 sites, 16 recruiting

  • Chiba University

    Chiba-sgi, Chiba, 263-8522

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Akihiro Fujino

    Recruiting

  • Saitama Children's Medical Center

    Chuo-ku, Saitama, 330-8777

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Akihiro Fujino

    Recruiting

  • Kyushu Univeristy

    Higashiku, Fukuoka, 812-8581

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Akihiro Fujino

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551

    Site Public Contact, 82-424-6042

    Akihiro Fujino

    Recruiting

  • Hyogo Prefectural Kobe Children's Hospital

    Kobe, Hyōgo, 650-0047

    Site Public Contact, info_kch@hp.pref.hyogo.jp

    Akihiro Fujino

    Recruiting

  • Kyoto Perfectural University of Medicine

    Kyoto, 602-8566

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Akihiro Fujino

    Recruiting

  • Niigata Cancer Centre

    Niigata, Chuo-ku, 951-8566

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Akihiro Fujino

    Recruiting

  • Hyogo College of Medicine

    Nishinomiya, Hyogo, 663-8501

    Suspended

  • Osaka City General Hospital

    Osaka, 534-0021

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Akihiro Fujino

    Recruiting

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

    Site Public Contact, 81-49-276-2028

    Akihiro Fujino

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Site Public Contact, hassi@med.hokudai.ac.jp

    Akihiro Fujino

    Recruiting

  • Tohoku University School of Medicine

    Sendai, Aoba-ku, 980-8574

    Site Public Contact, med-som@bureau.tohoku.ac.jp

    Akihiro Fujino

    Recruiting

  • Keio University

    Shinjuku-ku, Tokyo, 160-8582

    Site Public Contact, 03 5363-3848

    Akihiro Fujino

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 104 0045

    Site Public Contact, 81-3-3542-2511, www-admin@ncc.go.jp

    Akihiro Fujino

    Recruiting

  • Kokuritsu Seiiku Medical Research Center Hospital

    Tokyo, 157-8535

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Akihiro Fujino

    Recruiting

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki, 305-8576

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Akihiro Fujino

    Recruiting

  • Kanagawa Children's Medical Center

    Yokohama, Kanagawa, 232-8555

    Site Public Contact, 81 45-711-2351

    Akihiro Fujino

    Recruiting

Other trials in Japan

United Kingdom15 sites, 13 recruiting

  • Sheffield Children's Hospital

    Broomhall, England, S10 2TH

    Site Public Contact, r.innovation@nhs.net

    Sara J. Stoneham

    Recruiting

  • Addenbrookes Hospital-Medical School

    Cambridge, England, CB2 0QQ

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

  • Royal Hospital for Children and Young People

    Edinburgh, Scotland, EH9 1LF

    Site Public Contact, 0131 536 1000

    Sara J. Stoneham

    Recruiting

  • Beatson Oncology Center

    Glasgow, Scotland, G12 0YN

    Suspended

  • Royal Hospital for Children

    Glasgow, Scotland, G51 4TF

    Site Public Contact, Randdsystems.PF1@ggc.scot.nhs.uk

    Sara J. Stoneham

    Recruiting

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

  • University College London Hospitals NHS Trust - Foley Street

    London, England, W1W 6DN

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

  • Royal Manchester Children Hospital

    Manchester, England, M27 4HA

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

  • Royal Victoria Infirmary

    Newcastle, England, NE1 4LP

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

  • Freeman Hospital

    Newcastle upon Tyne, England, NE7 7DN

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

  • John Radcliffe Hospital

    Oxford, England, OX3 9DU

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

  • Weston Park Hospital

    Sheffield, England, S10 2SJ

    Suspended

  • Saint James's University Hospital

    West Yorkshire, England, LS9 7TF

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

  • Leeds General Infirmary

    West Yorkshire, LS1 3EX

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Sara J. Stoneham

    Recruiting

Other trials in United Kingdom

Australia8 sites, 7 recruiting

  • Monash Medical Center-Clayton Campus

    Clayton, Victoria, 3168

    Site Public Contact, (03) 9928 8111

    Michelle Martin

    Recruiting

  • John Hunter Children's Hospital

    Hunter Regional Mail Centre, New South Wales, 2310

    Site Public Contact, (02) 4985 5180

    Kristy McCarthy

    Recruiting

  • Royal Children's Hospital

    Parkville, Victoria, 3052

    Site Public Contact, 61 3 9345 5656, Jordan.Hansford@rch.org.au

    Molly Williams

    Recruiting

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6008

    Active, not recruiting

  • Perth Children's Hospital

    Perth, Western Australia, 6009

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Marianne B. Phillips

    Recruiting

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031

    Site Public Contact, (02) 9382-1721

    Draga Barbaric

    Recruiting

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101

    Site Public Contact, 61 7 3068 1111

    Steven A. Foresto

    Recruiting

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145

    Site Public Contact, 61-2-9845 1400

    Bhavna Padhye

    Recruiting

Other trials in Australia

New Zealand2 sites, 2 recruiting

  • Christchurch Hospital

    Christchurch, 8011

    Site Public Contact, 03 364 0640

    Tristan Pettit

    Recruiting

  • Starship Children's Hospital

    Grafton, Auckland, 1145

    Site Public Contact, 0800 728 436

    Mark A. Winstanley

    Recruiting

Other trials in New Zealand

Puerto Rico2 sites

  • HIMA San Pablo Oncologic Hospital

    Caguas, 00726

    Active, not recruiting

  • San Jorge Children's Hospital

    San Juan, 00912

    Active, not recruiting

Other trials in Puerto Rico

India1 site, 1 recruiting

  • Tata Memorial Hospital

    Mumbai, 400 012

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Badira C. Parambil

    Recruiting

Other trials in India

Saudi Arabia1 site

  • King Faisal Specialist Hospital and Research Centre

    Riyadh, 11211

    Suspended

Other trials in Saudi Arabia

About this study

Official title: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients with stage I (low risk) malignant germ cell tumors (Stratum 2), and at least 88% for patients with all stage/grade ovarian pure immature teratoma (Stratum 1).

II. To compare the event-free survival of a carboplatin versus (vs.) cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk non-seminomatous germ cell tumors.

IIa. To compare the event free survival (EFS) of a carboplatin-based regimen (carboplatin [C] etoposide [E] bleomycin [b]) vs. a cisplatin-based regimen (cisplatin [P]Eb) in children (less than 11 years in age) with standard risk germ cell tumors (GCT).

IIb. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen (BEP) in adolescents and young adults (ages 11 - < 25 years) with standard risk GCT.

SECONDARY OBJECTIVES:

  1. To compare the incidence of ototoxicity in children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy.

II. To refine and validate a novel patient-reported measure of hearing outcomes for children, adolescents and young adults with standard risk germ cell tumors.

III. To determine whether radiomic measures of body composition at diagnosis, end of therapy, and one year after end of therapy is better correlated with adverse events compared to body surface area in patients receiving chemotherapy for germ cell tumors.

EXPLORATORY OBJECTIVES:

  1. To prospectively determine the correlation of tumor marker decline (alpha-fetoprotein [FP] and beta-human chorionic gonadotropin [HCG]) with clinical outcome in low and standard risk germ cell tumor patients.

II. To compare self-reported peripheral neuropathy and other patient-reported outcomes between children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy.

III. Assess the relationship between hearing loss as measured by audiometry with the effects of tinnitus as assessed on the Adolescent and Young Adult Hearing Screening (AYA-HEARS) instrument.

IV. To evaluate the prognostic significance of serum micro ribonucleic acid (miRNA)s in stage I seminoma patients by collecting clinical data and serum specimens for future analysis.

  1. To compare differences in the proportion of patients with residual mass(es) ≥ 1 cm at the completion of chemotherapy among patients randomized to the cisplatin and carboplatin-containing arms and to compare the proportion undergoing post-chemotherapy surgery for residual mass(es), and the proportion of resected masses with viable malignancy, teratoma, or necrosis.

VI. To investigate whether there is an association between serum miRNAs measured immediately post-operatively and time-to-relapse in stage I non-seminomatous germ cell tumor patients and to estimate the trajectory of miRNA over time.

OUTLINE:

Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma malignant germ cell tumors (MGCT)s undergo observation and can transfer to standard risk arm at time of recurrence if eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or chest x-ray as well as blood sample collection throughout the trial to monitor for response and recurrence. Patients may also undergo a tumor biopsy throughout the trial.

Patients with standard risk 1 are randomized into 1 of 2 arms.

ARM I (CEb): Patients receive bleomycin intravenously (IV) over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.

ARM II (PEb): Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.

Patients with standard risk 2 are randomized into 1 of 2 arms.

ARM III (BEC): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.

ARM IV (BEP): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.

After completion of study treatment, patients are followed up every 2 months for 12 months, every 3-6 months to 24 months, every 6 months for years 3-5, and then annually for up to 10 years.

Being tested
Best Practice, Biopsy Procedure, Biospecimen Collection, Bleomycin Sulfate, Carboplatin
Medical subject headings
Neoplasms, Germ Cell and Embryonal, Carcinoma, Embryonal, Teratoma, Endodermal Sinus Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Undergo observation

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo a tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bleomycin SulfateBiological

    Also called Blanoxan, BleMomycine, Blenoxane, Bleo-cell

    Given IV

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo a CT scan

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Pulmonary Function TestProcedure or surgery

    Also called lung function test, PFT, Pulmonary Function Testing, Pulmonary Function Tests

    Undergo a pulmonary function test

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03067181
Study groupRoleWhat they receive
Arm I (bleomycin, carboplatin, etoposide)ExperimentalPatients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Biological: Bleomycin Sulfate; Drug: Carboplatin; Procedure: Computed Tomography; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Procedure: Pulmonary Function Test; Other: Questionnaire Administration
Arm II (bleomycin, etoposide, cisplatin)ExperimentalPatients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Biological: Bleomycin Sulfate; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Procedure: Pulmonary Function Test; Other: Questionnaire Administration
Arm III (bleomycin, etoposide, carboplatin)ExperimentalPatients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Biological: Bleomycin Sulfate; Drug: Carboplatin; Procedure: Computed Tomography; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Procedure: Pulmonary Function Test; Other: Questionnaire Administration
Arm IV (bleomycin, etoposide, cisplatin)ExperimentalPatients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Biological: Bleomycin Sulfate; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Etoposide; Procedure: Magnetic Resonance Imaging; Procedure: Pulmonary Function Test; Other: Questionnaire Administration
Low-Risk (observation)ExperimentalPatients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma or seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial.
Receives: Other: Best Practice; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    The time from study entry to the date of death, or date of last contact and ascertained as alive, whichever comes first.

    Measured: Two years post enrollment

  2. Event-free survival

    The time from study entry to the date of death, date of disease progression or recurrence, date of second malignant neoplasm or date of last contact and ascertained as alive, whichever comes first.

    Measured: Two years post enrollment

Secondary outcomes (3)

  1. Presence of hearing loss

    The hearing loss is evaluated according to the International Society of Pediatric Oncology criteria.

    Measured: 8 weeks after the last dose of platin therapy

  2. Adolescents and Young Adults-Hearing Screen (AYA HEARs)

    AYA HEARs is a 9-item questionnaire with each question scored on a 5-point Likert scale (range = 0-4).

    Measured: Baseline, end of therapy, 2 months post-end of therapy, and 1 year after enrollment

  3. Whole body lean body mass

    Imaging and radiology reports will be analyzed using Slice-O-Matic software (Tomovision), and imaging results will be used to calculate whole-body lean body mass.

    Measured: At diagnosis, at end of therapy, and up to 1 year after end of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2017
  2. Study start25 May 2017
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,780 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067181
Sponsor's protocol ID
AGCT1531
Other IDs
NCI-2017-00178, AGCT1531, AGCT1531, AGCT1531, U10CA180886
Status last verified
Apr 2026
First submitted
14 Feb 2017
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Trozzi R, Rosati A, Panico C, Perisiano C, Santoro A, Fagotti A. Extra-cranial meningioma associated with relapse of immature ovarian teratoma. Int J Gynecol Cancer. 2023 Oct 2;33(10):1649-1654. doi: 10.1136/ijgc-2023-004718. No abstract available.

    PubMed 37783480

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Best Practice, Biopsy Procedure and Biospecimen Collection in people with Childhood Extracranial Germ Cell Tumor and Extragonadal Embryonal Carcinoma, run by Children's Oncology Group at 629 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 51 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 629 sites in United States, Canada, Japan, United Kingdom, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Two years post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067181, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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