AzTrials
AzTrials

Embryonal RhabdomyosarcomaPhase 3NCT05304585

Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma

A Phase 3 study testing Biopsy Procedure, Bone Scan and Computed Tomography in people with Embryonal Rhabdomyosarcoma and Fusion-Negative Alveolar Rhabdomyosarcoma, run by Children's Oncology Group at 181 sites in 4 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the… Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
Biopsy Procedure, Bone Scan and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
181 sitesin 4 countries
Study dates
4 Aug 2022to 30 Jun 2030
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 Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial).
  • Patients must be =< 21 years at the time of enrollment.
  • Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients.
  • All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.
  • Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.
  • Patients will be eligible for the low-risk stratum (Regimen VAC/VA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.
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  • Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients >= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.
  • Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.
  • Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.
  • Patients must have a Lansky (for patients =< 16 years of age) or Karnofsky (for patients > 16 years of age) performance status score of >= 50. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score.
  • Peripheral absolute neutrophil count (ANC) >= 750/uL (within 7 days prior to enrollment).
  • Platelet count >= 75,000/uL (transfusion independent) (within 7 days prior to enrollment).
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine (within 7 days prior to enrollment) based on age/gender as follows:
  • Age: 1 month to < 6 months; Maximum serum creatinine (mg/dL): 0.4 (male) : 0.4 (female)
  • Age: 6 months to < 1 year; Maximum serum creatinine (mg/dL): 0.5 (male) : 0.5 (female)
  • Age: 1 to < 2 years; Maximum serum creatinine (mg/dL): 0.6 (male) : 0.6 (female)
  • Age: 2 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 (male) : 0.8 (female)
  • Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male) : 1 (female)
  • Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 (male) : 1.2 (female)
  • Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 (male) : 1.4 (female)
  • Age >= 16 years; Maximum serum creatinine (mg/dL): 1.7 (male) : 1.4 (female)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and
  • If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be < 3 x ULN for age.
  • Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L.
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L
  • If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be < 3 x ULN for age
  • Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
  • All patients and/or their parents or legal guardians must sign a written informed consent.
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Who cannot join

  • Patients who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.
  • Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.
  • Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.
  • Patients unable to undergo radiation therapy, if necessary, as specified in the protocol.
  • Evidence of uncontrolled infection.
  • 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.
  • Lactating females who plan to breastfeed their infants.
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

Trial locations and contacts

181 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

181 sites in 4 countries

United States166 sites, 164 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

  • 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

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125

    Rama Jasty

    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

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

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

    Masanori Hayashi

    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

    Christine A. Pratilas

    Recruiting

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

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

    Jamie M. Aye

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

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

    Martha M. Pacheco

    Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Site Public Contact, 877-726-5130

    Alison M. Friedmann

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Natalie B. Collins

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

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

    Ajay Gupta

    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

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

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

    Brian C. Belyea

    Recruiting

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

    Site Public Contact, 773-880-4562

    Jennifer L. Reichek

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Suspended

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

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

    Ami V. Desai

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

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

    Joseph G. Pressey

    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

  • 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

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

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

    Nkechi I. Mba

    Recruiting

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

    Site Public Contact, 972-566-5588

    Maurizio L. Ghisoli

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

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

    Avanthi T. Shah

    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

  • 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

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Alissa M. Martin

    Recruiting

  • Kaiser Permanente Downey Medical Center

    Downey, California, 90242

    Site Public Contact, 626-564-3455

    Robert M. Cooper

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Jessica M. Sun

    Recruiting

  • El Paso Children's Hospital

    El Paso, Texas, 79905

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

    Benjamin Carcamo

    Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

    Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org

    Robin Y. Dulman

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

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

    Samuel J. Milanovich

    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

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

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

    Brian Stover

    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

  • East Carolina University

    Greenville, North Carolina, 27834

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

    Andrea R. Whitfield

    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

  • 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

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033

    Site Public Contact, 717-531-6012

    Lisa M. McGregor

    Recruiting

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

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

    Iftikhar Hanif

    Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Site Public Contact, 808-983-6090

    Wade T. Kyono

    Recruiting

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

    Houston, Texas, 77030

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

    Stephanie Fetzko

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

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

    Najat C. Daw

    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

  • 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

    Sridhi Patel

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

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

    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

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916

    Site Public Contact, 865-541-8266

    Susan E. Spiller

    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

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

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

    Alan K. Ikeda

    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

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    James T. Badgett

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

    Site Public Contact, 501-364-7373

    Michael W. Bishop

    Recruiting

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

    Site Public Contact, 909-558-4050

    Albert Kheradpour

    Recruiting

  • Miller Children's and Women's Hospital Long Beach

    Long Beach, California, 90806

    Site Public Contact, 562-933-5600

    Jacqueline N. Casillas

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    Site Public Contact, 323-361-4110

    Sara Kreimer

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org

    Leo Mascarenhas

    Recruiting

  • Mattel Children's Hospital UCLA

    Los Angeles, California, 90095

    Site Public Contact, 310-825-6708

    Noah C. Federman

    Recruiting

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

    Site Public Contact, 502-629-5500, CancerResource@nortonhealthcare.org

    Michael J. Ferguson

    Recruiting

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

    Site Public Contact, 806-725-8657, mbisbee@providence.org

    Kishor M. Bhende

    Recruiting

  • UMC Cancer Center / UMC Health System

    Lubbock, Texas, 79415

    Site Public Contact, 806-775-8590

    Erin K. Barr

    Recruiting

  • Atrium Health Navicent

    Macon, Georgia, 31201

    Site Public Contact, 478-633-2152, andrew.weatherall@atriumhealth.org

    Sushmita Nair

    Recruiting

  • Valley Children's Hospital

    Madera, California, 93636

    Site Public Contact, 559-353-3000, Research@valleychildrens.org

    Ruetima Titapiwatanakun

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Margo L. Hoover-Regan

    Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Michelle A. Manalang

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Site Public Contact, 708-226-4357

    Eugene Suh

    Recruiting

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105

    Site Public Contact, 888-226-4343, referralinfo@stjude.org

    Alberto S. Pappo

    Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Aditi Dhir

    Recruiting

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

    Site Public Contact, 888-624-2778

    Maggie E. Fader

    Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-955-4727, MACCCTO@mcw.edu

    Kerri Becktell

    Recruiting

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

    Site Public Contact, 612-813-5913, pauline.mitby@childrensmn.org

    Michael K. Richards

    Recruiting

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

    Site Public Contact, 612-624-2620

    Robin L. Williams

    Recruiting

  • USA Health Strada Patient Care Center

    Mobile, Alabama, 36604

    Site Public Contact, 800-388-8721

    Hamayun Imran

    Recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

    Site Public Contact, 973-971-5900

    Kathryn L. Laurie

    Recruiting

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203

    Site Public Contact, 615-342-1919

    Clinton M. Carroll

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Site Public Contact, 800-811-8480

    Scott C. Borinstein

    Recruiting

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

    Site Public Contact, 732-776-4240

    Katharine Offer

    Recruiting

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

    Site Public Contact, 732-235-8675

    Scott Moerdler

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Farzana Pashankar

    Recruiting

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    New Hyde Park, New York, 11040

    Site Public Contact, 718-470-3460

    Carolyn F. Levy

    Recruiting

  • Children's Hospital New Orleans

    New Orleans, Louisiana, 70118

    Site Public Contact, 504-894-5377

    Maria C. Velez-Yanguas

    Recruiting

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

    Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org

    Craig Lotterman

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Site Public Contact, CancerTrials@nyulangone.org

    Elizabeth A. Raetz

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Pamela R. Merola

    Recruiting

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

    Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu

    Nobuko Hijiya

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Leonard H. Wexler

    Recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

    Site Public Contact, 973-926-7230, Christine.Kosmides@rwjbh.org

    Teena Bhatla

    Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

    Site Public Contact, 757-668-7243, CCBDCresearch@chkd.org

    Melissa S. Mark

    Recruiting

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois, 60453

    Site Public Contact, 847-723-7570

    Rebecca E. McFall

    Recruiting

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609

    Site Public Contact, 510-428-3264, PedOncRschOAK@ucsf.edu

    Jennifer G. Michlitsch

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Aarati V. Rao

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Rene Y. McNall-Knapp

    Recruiting

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska, 68114

    Site Public Contact, 402-955-3949

    Jill C. Beck

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Jill C. Beck

    Recruiting

  • Children's Hospital of Orange County

    Orange, California, 92868

    Site Public Contact, 714-509-8646, oncresearch@choc.org

    Elyssa M. Rubin

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32803

    Site Public Contact, 407-303-2090, FH.Cancer.Research@flhosp.org

    Fouad M. Hajjar

    Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806

    Site Public Contact, 321-841-5357, Jennifer.spinelli@orlandohealth.com

    Zhongbo Hu

    Recruiting

  • Nemours Children's Hospital

    Orlando, Florida, 32827

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

    Sridhi Patel

    Recruiting

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304

    Site Public Contact, 800-694-0012, ccto-office@stanford.edu

    Jay Michael S. Balagtas

    Recruiting

  • Advocate Children's Hospital-Park Ridge

    Park Ridge, Illinois, 60068

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Rebecca E. McFall

    Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Jeffrey H. Schwartz

    Recruiting

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

    Suspended

  • OSF Children's Hospital of Illinois

    Peoria, Illinois, 61637

    Site Public Contact, 309-624-4945, ChildrensHospitalofIllinois@osfhealthcare.org

    Prerna Kumar

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Site Public Contact, 267-425-5544, CancerTrials@email.chop.edu

    Naomi J. Balamuth

    Recruiting

  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

    Site Public Contact, 215-427-8991

    Gregory E. Halligan

    Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016

    Site Public Contact, 602-546-0920

    Nawal Merjaneh

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-692-8570, jean.tersak@chp.edu

    Jean M. Tersak

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Site Public Contact, 503-494-1080, trials@ohsu.edu

    Katrina Winsnes

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Site Public Contact, 401-444-1488

    Bradley DeNardo

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Site Public Contact, 775-982-5050, Renown-CRD@renown.org

    Alan K. Ikeda

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Frances Austin

    Recruiting

  • Carilion Children's

    Roanoke, Virginia, 24014

    Site Public Contact, 540-266-6238, wpmccarty@carilionclinic.org

    Erwood G. Edwards

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Wendy Allen-Rhoades

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Site Public Contact, 585-275-5830

    Rafi R. Kazi

    Recruiting

  • Corewell Health Children's

    Royal Oak, Michigan, 48073

    Site Public Contact, 248-551-7695

    Marie V. Nelson

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Site Public Contact, 916-734-3089

    Marcio H. Malogolowkin

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

    Site Public Contact, 801-585-5270

    Matthew Dietz

    Recruiting

  • Children's Hospital of San Antonio

    San Antonio, Texas, 78207

    Site Public Contact, 210-704-2894, bridget.medina@christushealth.org

    Julie Voeller

    Recruiting

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229

    Site Public Contact, 210-575-6240, Vinod.GidvaniDiaz@hcahealthcare.com

    Jose M. Esquilin

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Site Public Contact, 210-450-3800, phoresearchoffice@uthscsa.edu

    Aaron J. Sugalski

    Recruiting

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123

    Site Public Contact, 858-966-5934

    William D. Roberts

    Recruiting

  • Naval Medical Center -San Diego

    San Diego, California, 92134

    Site Public Contact, 619-532-8712

    Yoko T. Udaka

    Recruiting

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

    Site Public Contact, 877-827-3222, cancertrials@ucsf.edu

    Arun A. Rangaswami

    Recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

    Site Public Contact, 912-350-7887, Lorraine.OHara@hcahealthcare.com

    Andrew L. Pendleton

    Recruiting

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Aaron R. Weiss

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Site Public Contact, 866-987-2000

    Sarah E. Leary

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org

    Jordan Fritch-Hanson

    Recruiting

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

    Site Public Contact, 800-228-6618, HopeBeginsHere@providence.org

    Judy L. Felgenhauer

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Gregory P. Brandt

    Recruiting

  • Cardinal Glennon Children's Medical Center

    St Louis, Missouri, 63104

    Site Public Contact, 314-268-4000

    William S. Ferguson

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Amy Armstrong

    Recruiting

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Robin D. Hanson

    Recruiting

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

    Site Public Contact, 727-767-4784, Ashley.Repp@jhmi.edu

    Jennifer B. Dean

    Recruiting

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

    Site Public Contact, 315-464-5476

    Melanie A. Comito

    Recruiting

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington, 98405

    Site Public Contact, 253-403-1461, research@multicare.org

    Robert G. Irwin

    Recruiting

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

    Site Public Contact, 253-968-6144, melissa.a.forouhar.mil@health.mil

    Melissa A. Forouhar

    Recruiting

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida, 33607

    Site Public Contact, 813-357-0849, jennifer.manns@baycare.org

    Don E. Eslin

    Recruiting

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

    Site Public Contact, 254-724-5407

    Nicholas W. McGregor

    Recruiting

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Alice Lee

    Recruiting

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Jamie L. Dargart

    Recruiting

  • New York Medical College

    Valhalla, New York, 10595

    Site Public Contact, 914-594-3794

    Andrew J. Bellantoni

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Site Public Contact, 202-444-2223

    Caileigh Pudela

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    Site Public Contact, 202-476-2800, OncCRC_OnCall@childrensnational.org

    Jeffrey S. Dome

    Recruiting

  • Saint Mary's Medical Center

    West Palm Beach, Florida, 33407

    Site Public Contact, 561-822-4745

    Matthew D. Ramirez

    Recruiting

  • Wesley Medical Center

    Wichita, Kansas, 67214

    Site Public Contact, 316-962-7802, WesleyResearch@wesleymc.com

    Nathan S. Hall

    Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

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

    Sridhi Patel

    Recruiting

  • Northwestern Medicine Central DuPage Hospital

    Winfield, Illinois, 60190

    Site Public Contact, 630-315-1918, Claudine.Gamster@CadenceHealth.org

    Jennifer L. Reichek

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Site Public Contact, 336-713-6771

    Sarah Supples

    Recruiting

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

    Site Public Contact, 508-856-3216, cancer.research@umassmed.edu

    Stefanie R. Lowas

    Recruiting

Other trials in United States

Canada10 sites, 9 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

  • 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

  • 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

    Suspended

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

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

    Anita Villani

    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

Australia3 sites, 3 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

  • 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

    Mandy PohLui de Silva

    Recruiting

Other trials in New Zealand

About this study

Official title: A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the failure free survival (FFS) of patients with very low-risk (VLR) rhabdomyosarcoma (RMS) (fusion negative [FN], stage 1, clinical group [CG] I, MYOD1 wildtype [WT], TP53 [WT]) when treated with 24 weeks of vincristine and dactinomycin (VA).

II. To evaluate the FFS of patients with low-risk (LR) RMS (FN, stage 1 CG II, or stage 2 CG I/II or CG III [orbit only], MYOD1 WT, TP53 WT) when treated with 12 weeks of vincristine, dactinomycin and cyclophosphamide (VAC) followed by 12 weeks of VA.

SECONDARY OBJECTIVES:

  1. To evaluate the overall survival (OS) of patients with VLR RMS treated with 24 weeks of VA.

II. To evaluate the OS of patients with LR RMS treated with 12 weeks of VAC followed by 12 weeks of VA.

III. To demonstrate the feasibility of central molecular risk stratification of patients with newly diagnosed RMS in the context of a prospective clinical trial.

EXPLORATORY OBJECTIVES:

  1. To collect blood and tissue samples for banking at baseline, during treatment, at the end of therapy, and at the time of progression to bank for future research.

II. To describe the methylation array profile of patients with fusion negative, low-risk rhabdomyosarcoma.

III. To describe the outcomes of patients with VLR or LR RMS and MYOD1 or TP53 mutations treated with intensified therapy.

OUTLINE: Patients are assigned to 1 of 2 regimens based on clinical features. Patients with positive mutation status are transitioned to a third regimen, Regimen M.

REGIMEN VA: Patients with VLR RMS receive vincristine intravenously (IV) on day 1 of each cycle and days 8 and 15 of cycles 1, 3, 5, and 7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3).

REGIMEN VAC/VA: Patients with LR RMS receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 1-3. Patients also receive dactinomycin IV over 1-5 minutes or 10-15 minutes and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 5-7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Patients may also undergo radiation therapy at cycle 5.

REGIMEN M: Patients receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 2-4, 7-8, and 11-12 and dactinomycin IV over 1-5 minutes or 10-15 minutes on day 1 of cycles 2-5 and 8-14. Patients also receive cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 12-13 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo radiation therapy at cycle 5.

Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, positron emission tomography (PET) scan and tumor biopsy throughout the study.

Being tested
Biopsy Procedure, Bone Scan, Computed Tomography, Cyclophosphamide, Dactinomycin
Medical subject headings
Rhabdomyosarcoma, Embryonal

What participants receive

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

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

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

    Undergo CT scan

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518

    Given IV

  • DactinomycinBiological

    Also called Actinomycin A IV, Actinomycin C1, Actinomycin D, Actinomycin I1

    Given IV

  • Magnetic Resonance ElastographyProcedure or surgery

    Also called MRE

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation

  • VincristineDrug

    Also called LCR, Leurocristine, VCR, Vincrystine

    Given IV

Study groups in NCT05304585
Study groupRoleWhat they receive
Regimen M (positive mutation)ExperimentalPatients receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 2-4, 7-8, and 11-12 and dactinomycin IV over 1-5 minutes or 10-15 minutes on day 1 of cycles 2-5 and 8-14. Patients also receive cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 12-13 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo radiation therapy at cycle 5. Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
Receives: Procedure: Biopsy Procedure; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Cyclophosphamide; Biological: Dactinomycin; Procedure: Magnetic Resonance Elastography; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy; Drug: Vincristine
Regimen VA (VLR RMS)ExperimentalPatients with VLR RMS receive vincristine intravenously (IV) on day 1 of each cycle and days 8 and 15 of cycles 1, 3, 5, and 7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
Receives: Procedure: Biopsy Procedure; Procedure: Bone Scan; Biological: Dactinomycin; Procedure: Magnetic Resonance Elastography; Procedure: Positron Emission Tomography; Drug: Vincristine
Regimen VAC/VA (VL RMS)ExperimentalPatients with LR RMS receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 1-3. Patients also receive dactinomycin IV over 1-5 minutes or 10-15 minutes and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 5-7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Radiation therapy (if needed) will be administered at cycle 5.Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
Receives: Procedure: Biopsy Procedure; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Cyclophosphamide; Biological: Dactinomycin; Procedure: Magnetic Resonance Elastography; Procedure: Positron Emission Tomography; Drug: Vincristine

What is being measured

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

  1. Failure free survival (FFS) for very low risk patients

    The Kaplan-Meier method will be used to estimate 3-year FFS along with 80% log-minus-log transformed confidence limits for very low risk (VLR) patients.

    Measured: From study enrollment to disease progression, recurrence, or death as a first event, assessed up to 3 years

  2. Failure free survival (FFS) for low risk patients

    The Kaplan-Meier method will be used to estimate 3 year FFS along with 80% log-minus-log transformed confidence limits for low risk (LR) patients.

    Measured: From study enrollment to disease progression, recurrence, or death as a first event, assessed up to 3 years

Secondary outcomes (3)

  1. Overall survival (OS) for very low risk patients

    Log-rank test will be used to compare the OS of patients with VLR rhabdomyosarcoma (RMS) treated with 24 weeks of vincristine, dactinomycin (VA) to the VLR RMS patients from ARST0331 and D9602 with the same inclusion criteria.

    Measured: From study entry to death of any cause, assessed up to 5 years

  2. Overall survival (OS) for low risk patients

    Log-rank test will be used to compare the OS from LR RMS patients to LR RMS patients from ARST0331 and D9602 with the same inclusion criteria.

    Measured: From study entry to death of any cause, assessed up to 5 years

  3. Feasibility of central molecular risk stratification of patients assessed by the percentage of patients who have molecular testing results returned by 6 weeks

    If the percentage of patients who have molecular testing results returned by 6 weeks is >= 80% then the central molecular risk stratification is considered feasible.

    Measured: Up to 24 weeks

Timeline

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

  1. First posted31 Mar 2022
  2. Study start4 Aug 2022
  3. Primary completion30 Jun 2030 (estimated)
  4. Study completion30 Jun 2030 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
205 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304585
Sponsor's protocol ID
ARST2032
Other IDs
NCI-2022-01012, ARST2032, ARST2032, U10CA180886
Status last verified
Oct 2025
First submitted
24 Feb 2022
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biopsy Procedure, Bone Scan and Computed Tomography in people with Embryonal Rhabdomyosarcoma and Fusion-Negative Alveolar Rhabdomyosarcoma, run by Children's Oncology Group at 181 sites in 4 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 29 inclusion and 8 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 181 sites in United States, Canada, Australia, New Zealand. 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?

Failure free survival (FFS) for very low risk patients (time frame: From study enrollment to disease progression, recurrence, or death as a first event, assessed up to 3 years). 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 NCT05304585.

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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