Stage III Colon CancerPhase 2/3CIRCULATE-USNCT05174169
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
A Phase 2/3 study testing Signatera test, mFOLFOX6 3-6 month and CAPOX 3 month in people with Stage III Colon Cancer, run by NRG Oncology at 1,085 sites in 3 countries.
Trial summary
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Colon Cancer
- What is being tested?
- Signatera test, mFOLFOX6 3-6 month and CAPOX 3 month
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,912 participants
- Where
- 1,085 sitesin 3 countries
- Study dates
- 8 Jul 2022to 10 Mar 2030
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have an ECOG performance status of 0 or 1.
- Patients must have histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria.
- No radiographic evidence of overt metastatic disease within 45 days prior to Step 1/Study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis).
- The distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation).
- The patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible.
- The resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera (after Step 1/Study entry and before Step2/Randomization). Patient must have sufficient tissue to meet protocol requirements. This blood specimen for the Signatera assay must be collected after surgery (and recommended at least 14 days post surgery).
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- Tumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded.
- The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan).
- The interval between surgery (post-operative Day 7) and Step 1/Study entry must be no more than 60 days. NOTE: Step 1/Study Entry may occur as early as post operative Day 7, but it cannot occur beyond 60 days from the actual date of the patient's surgery.
- Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.
- Adequate hematologic function within 28 days before Step 1/Study entry defined as follows:
- Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
- Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.
- BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.
- Platelet count must be greater than or equal to 100,000/mm3; and
- Hemoglobin must be greater than or equal to 9 g/dL.
- Adequate hepatic function within 28 days before Step 1/Study entry defined as follows:
- total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and
- alkaline phosphatase must be less than 2.5 x ULN for the lab; and
- AST and ALT must be less than 2.5 x ULN for the lab.
- Adequate renal function within 28 days before Step 1/Study entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.
- For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL) NOTE: Adjusted body weight (AdjBW) should be used for patients that have BMI greater than or equal to 28 (less than or equal to 30% above IBW).
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Pregnancy test (urine or serum according to institutional standard) done within 14 days before Step 1/Study entry must be negative (for women of childbearing potential only).
- Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine.
- Eligibility Criteria for Cohort A Arm-2 patients on Second Randomization
- Patient must have developed a ctDNA +ve assay during serial monitoring.
- Patient's willingness to be re-randomized affirmed.
- The patient must continue to have an ECOG performance status of 0 or 1.
- No radiographic evidence of overt metastatic disease.
- Pregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only).
- Adequate hematologic function within 28 days before second randomization defined as follows:
- Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
- Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.
- BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.
- Platelet count must be greater than or equal to 100,000/mm3; and
- Hemoglobin must be greater than or equal to 9 g/dL.
- Adequate hepatic function within 28 days before second randomization defined as follows:
- total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and
- alkaline phosphatase must be less than 2.5 x ULN for the lab; and
- AST and ALT must be less than 2.5 x ULN for the lab.
- Adequate renal function within 28 days before second randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.
- For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL)
Who cannot join
- Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).
- Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.
- Tumor-related bowel perforation.
- History of prior invasive colon malignancy, regardless of disease-free interval.
- History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary.
- Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and/or radiation is warranted are not permitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians' discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but not required after consent. The optional cycle of chemotherapy should be started greater than or equal to 4 weeks from surgery and while awaiting Step 2 randomization.
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- Other invasive malignancy within 5 years before Step 1/Study entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ.
- Synchronous primary rectal and/ or colon cancers.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- Sensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0.
- Blood transfusion within two weeks before collection of blood for central ctDNA testing.
- Active seizure disorder uncontrolled by medication.
- Active or chronic infection requiring systemic therapy.
- Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.
- Patients known to have Gilbert's Syndrome or homozygosity for UGT1A128 polymorphism.
- Pregnancy or lactation at the time of Step 1/Study entry.
- Co-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up).
- Ineligibility Criteria for Cohort A Arm-2 patients on Second Randomization
- Pregnancy or lactation at the time of randomization.
- No longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator.
Trial locations and contacts
1,085 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Langer contact
340 sites in 3 countries
United States300 sites, 257 recruiting
- Recruiting
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
Site Public Contact, 808-539-2273, info@hawaiicancercare.com
Jared D. Acoba
- Recruiting
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Site Public Contact, 808-486-6000
Jared D. Acoba
- Recruiting
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706
Site Public Contact, rohta@queens.org
Jared D. Acoba
- Recruiting
Abbeville General Hospital
Abbeville, Louisiana, 70510
Site Public Contact, 337-898-6413
Augusto C. Ochoa
- Recruiting
UM Upper Chesapeake Hematology and Oncology - Aberdeen
Aberdeen, Maryland, 21001
Site Public Contact, 443-643-1029, nfadrwoski@umm.edu
Ashkan Bahrani
- Recruiting
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, 57401
Site Public Contact, 605-622-8700, oncregulatory@avera.org
Heidi A. McKean
- Recruiting
Summa Health System - Akron Campus
Akron, Ohio, 44304
Site Public Contact, 330-375-4221, cancerresearch@summahealth.org
Bradley T. Clifford
- Recruiting
Cleveland Clinic Akron General
Akron, Ohio, 44307
Site Public Contact, 866-223-8100, CancerAnswer@ccf.org
Judy Peih-Ying Tsai
- Recruiting
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
Site Public Contact, 229-312-0405, ga_cares@augusta.edu
Anand P. Jillella
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Alissa Greenbaum
- Recruiting
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Site Public Contact, 505-559-6113, WBurman@phs.org
Alissa Greenbaum
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Tareq Al baghdadi
- Recruiting
Aultman Alliance Community Hospital
Alliance, Ohio, 44601
Site Public Contact, 330-363-1250
Raza A. Khan
- Recruiting
AdventHealth Altamonte
Altamonte Springs, Florida, 32701
Site Public Contact, 407-303-2200
Mohamedtaki A. Tejani
- Recruiting
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
Site Public Contact, 618-463-5623
Jay W. Carlson
- Recruiting
UPMC Altoona
Altoona, Pennsylvania, 16601
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Anwaar Saeed
- Recruiting
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
Site Public Contact, 806-212-1985, Gina.Cravey@bsahs.org
Anita Ravipati
- Recruiting
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003
Site Public Contact, 801-855-4100, officeofresearch@imail.org
Ramya Thota
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Gary L. Buchschacher
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
John C. Krauss
- Recruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Site Public Contact, 877-642-4691, Kpoct@kp.org
Tatjana Kolevska
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Matthias Weiss
- Recruiting
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Appleton, Wisconsin, 54915
Site Public Contact, AWRI.inquiry@ascension.org
Shannon Offerman
- Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
PCR Oncology
Arroyo Grande, California, 93420
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
University Cancer and Blood Center LLC
Athens, Georgia, 30607
Site Public Contact, research@universitycancer.com
Anand P. Jillella
- Active, not recruiting
Piedmont Hospital
Atlanta, Georgia, 30309
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-303-3355, ClinicalTrials@northside.com
Aldemar Montero
- Recruiting
Sutter Auburn Faith Hospital
Auburn, California, 95602
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, 95603
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Site Public Contact, 207-626-4855
Na Liu
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Christopher H. Lieu
- Suspended
Rush-Copley Medical Center
Aurora, Illinois, 60504
- Recruiting
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
Site Public Contact, ncorp@aah.org
Antony Ruggeri
- Recruiting
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701
Site Public Contact, 512-324-7991
Om N. Pandey
- Recruiting
University of Texas at Austin
Austin, Texas, 78712
Site Public Contact, 512-232-1543, irb@austin.utexas.edu
Om N. Pandey
- Recruiting
Avon - Richard E Jacobs Health Center
Avon, Ohio, 44011
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Kanika Nair
- Suspended
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
- Recruiting
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301
Site Public Contact, 661-323-4673
Ricardo Salas
- Recruiting
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Gary L. Buchschacher
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Site Public Contact, 443-849-3706
Gang Chen
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Site Public Contact, 410-601-9083
Pallavi P. Kumar
- Recruiting
Saint Agnes Hospital
Baltimore, Maryland, 21229
Site Public Contact, 410-368-2910
Carole B. Miller
- Recruiting
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237
Site Public Contact, 443-777-7364
Benjamin A. Weinberg
- Recruiting
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239
Site Public Contact, 410-261-8151, Barbara.rector@medstar.net
Benjamin A. Weinberg
- Recruiting
Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland, 21244
Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org
James Liu
- Recruiting
Summa Health System - Barberton Campus
Barberton, Ohio, 44203
Site Public Contact, 330-375-4221, cancerresearch@summahealth.org
Bradley T. Clifford
- Recruiting
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Antony Ruggeri
- Recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Medical Center of Baton Rouge
Baton Rouge, Louisiana, 70816
Site Public Contact, 225-761-5346, Camille.Beck@Ochsner.org
Lingling Du
- Recruiting
Ochsner High Grove
Baton Rouge, Louisiana, 70836
Site Public Contact, 225-761-5346, Camielle.beck@ochsner.org
Lingling Du
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
- Recruiting
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Anwaar Saeed
- Recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Site Public Contact, 443-643-3010
Ashkan Bahrani
- Recruiting
FHCC Overlake
Bellevue, Washington, 98004
Site Public Contact, 425-454-2148
Nancy Y. Cui
- Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Gary L. Buchschacher
- Recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Suspended
Summit Medical Group
Berkeley Heights, New Jersey, 07922
- Recruiting
ThedaCare Cancer Care - Berlin
Berlin, Wisconsin, 54923
Site Public Contact, 920-364-3605, ResearchDept@thedacare.org
Matthias Weiss
- Recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Site Public Contact, 802-225-5400
Jeremy Dressler
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Tareq Al baghdadi
- Recruiting
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu
Saima Sharif
- Recruiting
Beverly Hospital
Beverly, Massachusetts, 01915
Site Public Contact, 978-922-3000 ext. 2405
Karl J. D'Silva
- Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Site Public Contact, towercancerresearch@toweroncology.com
Jun Gong
- Suspended
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Site Public Contact, 800-648-6274
Ramya Thota
- Active, not recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Dan S. Zuckerman
- Recruiting
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
Site Public Contact, 913-948-5588, aroland@kccop.org
Jay W. Carlson
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org
Jacob M. Elkon
- Active, not recruiting
Boston Medical Center
Boston, Massachusetts, 02118
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Cox Cancer Center Branson
Branson, Missouri, 65616
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
United Hospital Center
Bridgeport, West Virginia, 26330
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Nour Daboul
- Recruiting
Intermountain Health Platte Valley Hospital
Brighton, Colorado, 80601
Site Public Contact, peaksresearch@imail.org
Ramya Thota
- Recruiting
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts, 02135
Site Public Contact, 617-789-2903
Alys Malcolm
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Brookfield, Wisconsin, 53045
Site Public Contact, AWRI.Inquiry@Ascension.org
Shannon Offerman
- Recruiting
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Site Public Contact, 718-780-3677, Adg9003@nyp.org
Uqba Khan
- Suspended
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
- Suspended
Saint Anne Hospital
Burien, Washington, 98166
- Recruiting
Kaiser Permanente-Burke Medical Center
Burke, Virginia, 22015
Site Public Contact, 240-632-4285, Charmaine.A.Mckie@kp.org
James Liu
- Recruiting
Mills-Peninsula Medical Center
Burlingame, California, 94010
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Lahey Clinic
Burlington, Massachusetts, 01805
Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org
Karl J. D'Silva
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Site Public Contact, 802-656-4101, rpo@uvm.edu
Jeremy Dressler
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Jeremy Dressler
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Anwaar Saeed
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Tareq Al baghdadi
- Suspended
Cambridge Medical Center
Cambridge, Minnesota, 55008
- Recruiting
Marshall Cancer Center
Cameron Park, California, 95682
Site Public Contact, 530-672-7050, cancerservices@marshallmedical.org
Edward J. Kim
- Recruiting
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, 95682
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Active, not recruiting
UPMC Camp Hill
Camp Hill, Pennsylvania, 17011
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
Site Public Contact, 888-293-4673
Mitchell Haut
- Recruiting
Aultman Health Foundation
Canton, Ohio, 44710
Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com
Raza A. Khan
- 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
AtlantiCare Health Park-Cape May Court House
Cape May Court House, New Jersey, 08210
Site Public Contact, 609-677-7735
Devon S. Mckenzie
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Anwaar Saeed
- Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@commonspirit.org
Loretta J. Nastoupil
- Suspended
Caro Cancer Center
Caro, Michigan, 48723
- Recruiting
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Site Public Contact, 515-689-7658, sbenson@iora.org
Seema Harichand-Herdt
- Recruiting
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703
Site Public Contact, 702-384-0013, research@sncrf.org
Khawaja S. Jahangir
- 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
Duke Cancer Center Cary
Cary, North Carolina, 27518
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Aman Opneja
- Recruiting
UNC Health Cancer Care Cary
Cary, North Carolina, 27518
Site Public Contact, 919-784-2500, CancCtrOncologyClinicalResearch@unchealth.unc.edu
Ranjit Joseph
- Recruiting
Waverly Hematology Oncology
Cary, North Carolina, 27518
Site Public Contact, 919-350-1700, TCHILDRESS@wakemed.org
Vijay Chaudhary
- Recruiting
Eden Hospital Medical Center
Castro Valley, California, 94546
Site Public Contact, clinicalresearch@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720
Site Public Contact, 435-868-5680, officeofresearch@imail.org
Ramya Thota
- Recruiting
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Site Public Contact, 319-297-2900
Bharat Jenigiri
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
AdventHealth Celebration
Celebration, Florida, 34747
Site Public Contact, 407-303-4120
Mohamedtaki A. Tejani
- Suspended
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania, 17201
Site Public Contact, 717-217-6020
Marianne Spengler
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Hanna K. Sanoff
- Suspended
Geauga Hospital
Chardon, Ohio, 44024
- Active, not recruiting
Roper Hospital
Charleston, South Carolina, 29401
- Active, not recruiting
Charleston Oncology - Roper
Charleston, South Carolina, 29403
- Active, not recruiting
Bon Secours Saint Francis Hospital
Charleston, South Carolina, 29414
- Active, not recruiting
Charleston Oncology - Saint Francis
Charleston, South Carolina, 29414
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Toros Dincman
- Recruiting
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org
Anahat Kaur
- Recruiting
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Site Public Contact, 800-804-9376
Kunal C. Kadakia
- Recruiting
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210
Site Public Contact, 980-442-2000
Kunal C. Kadakia
- Recruiting
Levine Cancer Institute-SouthPark
Charlotte, North Carolina, 28211
Site Public Contact, 980-442-2000
Kunal C. Kadakia
- Recruiting
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262
Site Public Contact, 800-804-9376
Kunal C. Kadakia
- Recruiting
Levine Cancer Institute-Ballantyne
Charlotte, North Carolina, 28277
Site Public Contact, 800-804-9376
Kunal C. Kadakia
- Recruiting
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota, 55318
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Steven J. Cohen
- Recruiting
Cancer Specialists of Tidewater Limited
Chesapeake, Virginia, 23320
Site Public Contact, 757-534-6863, casey.morris@rivhs.com
Khalid Matin
- Recruiting
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608
Site Public Contact, 773-257-5960, suhi@sinai.org
Pam G. Khosla
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Mary F. Mulcahy
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Site Public Contact, 312-864-5204
Deimante M. Tamkus
- Recruiting
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu
Audrey Kam
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Shikha Jain
- Recruiting
Swedish Covenant Hospital
Chicago, Illinois, 60625
Site Public Contact, 773-878-8200
Carolina Soto Chervin
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Blase N. Polite
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Antony Ruggeri
- Recruiting
Enloe Medical Center
Chico, California, 95926
Site Public Contact, 530-332-4700
Edward J. Kim
- Recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Site Public Contact, 877-779-7585, Jeffh@columbusccop.org
Aruna C. Gowda
- Recruiting
Ascension Calumet Hospital-Chilton
Chilton, Wisconsin, 53014
Site Public Contact, AWRI.inquiry@ascension.org
Shannon Offerman
- Recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Michael Husak
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Adam Rojan
- Recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Moh'd Khushman
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Dan S. Zuckerman
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
- Recruiting
Morton Plant Hospital
Clearwater, Florida, 33756
Site Public Contact, 855-314-8646
Hassan M. Ebrahim
- Suspended
Case Western Reserve University
Cleveland, Ohio, 44106
- Active, not recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
- Recruiting
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Kanika Nair
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Kanika Nair
- Recruiting
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 20735
Site Public Contact, 301-877-4673
Benjamin A. Weinberg
- 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
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Sohail A. Minhas
- Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Christopher H. Lieu
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Christopher H. Lieu
- Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
Site Public Contact, 573-882-7440
RuoBing Xue
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Sohail A. Minhas
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Pannaga Malalur
- Recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
Site Public Contact, 614-488-2745, Jeffh@columbusccop.org
Aruna C. Gowda
- Suspended
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
- Suspended
Riverside Methodist Hospital
Columbus, Ohio, 43214
- Suspended
Grant Medical Center
Columbus, Ohio, 43215
- 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
- Suspended
Doctors Hospital
Columbus, Ohio, 43228
- Recruiting
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Site Public Contact, 603-224-2556
Gina M. DiVenuti
- Recruiting
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Site Public Contact, 800-804-9376
Kunal C. Kadakia
- Recruiting
UT MD Anderson - The Woodlands
Conroe, Texas, 77384
Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org
Nageshwara V. Dasari
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Suspended
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Recruiting
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, 70433
Site Public Contact, 985-809-5668, Cheryl.kesler@ochsner.org
Lingling Du
- Recruiting
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania, 16066
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Anwaar Saeed
- Suspended
Greater Regional Medical Center
Creston, Iowa, 50801
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Moh'd Khushman
- Recruiting
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307
Site Public Contact, 219-836-6879, CancerResearch@powershealth.org
Suparna Mantha
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Antony Ruggeri
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Antony Ruggeri
- Recruiting
UPMC Western Maryland
Cumberland, Maryland, 21502
Site Public Contact, 240-964-1400
Anwaar Saeed
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Nilesh Verma
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Nilesh Verma
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Nilesh Verma
- Recruiting
Danbury Hospital
Danbury, Connecticut, 06810
Site Public Contact, 833-223-4732
Wenli Gao
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Mina Makary
- Suspended
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, 36526
- Recruiting
Sutter Davis Hospital
Davis, California, 95616
Site Public Contact, NCIclinicaltrials@sutterhealth.org
Jorge A. Garcia-Young
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Site Public Contact, 937-276-8320
Tarek M. Sabagh
- Recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Howard M. Gross
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
Site Public Contact, 248-551-7695
Andrew A. Muskovitz
- 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
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Mary F. Mulcahy
- Suspended
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
- Suspended
Grady Memorial Hospital
Delaware, Ohio, 43015
- Recruiting
Denver Health Medical Center
Denver, Colorado, 80204
Site Public Contact, 303-777-2663, ccrp@co-cancerresearch.org
Ankita Tandon
- Recruiting
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
UCHealth - Cherry Creek
Denver, Colorado, 80206
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Christopher H. Lieu
- Suspended
AdventHealth Porter
Denver, Colorado, 80210
- Recruiting
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
Site Public Contact, 303-318-3413
Ramya Thota
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Jeremy S. Kortmansky
- 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
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org
Tareq Al baghdadi
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, 18519
Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu
Mina Makary
- Recruiting
Dillon Health Center/Shaw Cancer Center
Dillon, Colorado, 80435
Site Public Contact, 970-470-7170
Erin Schwab
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Active, not recruiting
Bayhealth Hospital Kent Campus
Dover, Delaware, 19901
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Antony Ruggeri
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Richard T. Lee
- Suspended
Epic Care-Dublin
Dublin, California, 94568
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Tatjana Kolevska
- Suspended
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
- Suspended
Dublin Methodist Hospital
Dublin, Ohio, 43016
- Recruiting
Northside Hospital - Duluth
Duluth, Georgia, 30096
Site Public Contact, 404-303-3355, Clinical.trials@northside.com
Aldemar Montero
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
Mercy Medical Center
Durango, Colorado, 81301
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Aman Opneja
- Recruiting
Northwest Oncology LLC
Dyer, Indiana, 46311
Site Public Contact, 219-924-8178
Suparna Mantha
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Henry Ford River District Hospital
East China Township, Michigan, 48054
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Tareq Al baghdadi
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Tareq Al baghdadi
- Active, not recruiting
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Michael Husak
- Active, not recruiting
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Joleen M. Hubbard
- Recruiting
STCC at DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Site Public Contact, 956-362-2390, dhrresearch@dhr-rgv.com
Jose Cruz
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Dan S. Zuckerman
- Recruiting
Shaw Cancer Center
Edwards, Colorado, 81632
Site Public Contact, 970-569-7429
Erin Schwab
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
AtlantiCare Surgery Center
Egg Harbor, New Jersey, 08234
Site Public Contact, 609-748-7200
Devon S. Mckenzie
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Antony Ruggeri
- Recruiting
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
Elizabeth, New Jersey, 07207
Site Public Contact, 908-994-8000
Howard S. Hochster
- Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org
Loretta J. Nastoupil
- Recruiting
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Site Public Contact, 630-758-5460, Jrohde@emhc.org
Mohammed S. Azeem
- Suspended
Epic Care Partners in Cancer Care
Emeryville, California, 94608
- Suspended
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
- Recruiting
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522
Site Public Contact, 717-721-4840
Marianne Spengler
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Anwaar Saeed
- Recruiting
Saint Vincent Hospital
Erie, Pennsylvania, 16544
Site Public Contact, 814-452-5000
Dulabh K. Monga
Canada31 sites, 29 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Site Public Contact, 705-739-5661
Coralea Kappel
- Recruiting
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Patricia Tang
- Recruiting
Cambridge Memorial Hospital
Cambridge, Ontario, N1R 3G2
Site Public Contact, 519-621-2333
Skander Ghedira
- Recruiting
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec, J4V 2H1
Site Public Contact, 450-466-5065
Melina Boutin
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Site Public Contact, 905-387-9495
Shivani Dadwal
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Site Public Contact, 613-549-6666, cc-clinicaltrials@kgh.kari.net
Christopher M. Booth
- Recruiting
Waterloo Regional Health Network
Kitchener, Ontario, N2G 1G3
Site Public Contact, 519-749-4370, research@wrhn.ca
Anupam Batra
- Suspended
Hotel-Dieu De Levis
Lévis, Quebec, G6V 3Z1
- Recruiting
London Regional Cancer Program
London, Ontario, N6A 4L6
Site Public Contact, 519-685-8600
Elena V. Tsvetkova
- Recruiting
Markham Stouffville Hospital
Markham, Ontario, L3P 7P3
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Sam Babak
- Recruiting
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Site Public Contact, 514-252-3400 ext. 3329
Mikael Soucisse
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Site Public Contact, 514-340-8222 ext. 8248
Petr Kavan
- Recruiting
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Site Public Contact, 514-338-2172
Setareh Samimi
- Recruiting
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, L3Y 2P9
Site Public Contact, 905-895-4521 ext. 6820
Cynthia Luk
- Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Site Public Contact, 905-576-8711 ext. 4258
Amin Kay
- Recruiting
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6
Site Public Contact, 613-761-4395
Tina Hsu
- Recruiting
BCCA-Cancer Centre for the North
Prince George, British Columbia, V2M 7E9
Site Public Contact, 855-775-7300
Jonathan M. Loree
- Recruiting
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6
Site Public Contact, rechclinique@crchuq.ulaval.ca
Maxime Chenard-Poirier
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Site Public Contact, 306-766-2213
Kimberly M. Hagel
- Recruiting
Niagara Health System-Saint Catharines General
Saint Catharines, Ontario, L2S 0A9
Site Public Contact, 905-682-6451
Radhika Yelamanchili
- Recruiting
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Site Public Contact, 506-648-6890
James Michael
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Site Public Contact, 306-655-2914
Shahid Ahmed
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4
Site Public Contact, 819-820-6480, crcinformation.chus@ssss.gouv.qc.ca
Frederic Lemay
- Recruiting
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Site Public Contact, 709-777-7589
Angela Hyde
- Recruiting
North York General Hospital
Toronto, Ontario, M2K 1E1
Site Public Contact, 416-756-6000
Kathryn A. Towns
- Recruiting
Humber River Hospital
Toronto, Ontario, M3M 0B2
Site Public Contact, 416-242-1000, research@hrh.ca
Gautam Sudan
- Recruiting
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Site Public Contact, 416-480-5000
Anthony C. Lott
- Recruiting
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8
Site Public Contact, 416-864-6060 ext. 7830
Suneil Khanna
- Recruiting
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Site Public Contact, 888-939-3333
Jonathan M. Loree
- Recruiting
BCCA-Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Site Public Contact, 604-877-6010
Georgia Geller
- Active, not recruiting
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Puerto Rico9 sites, 9 recruiting
- Recruiting
Pan American Center for Oncology Trials LLC - Cayey
Cayey, 00646
Site Public Contact, 787-407-3333, info@panoncologytrials.com
Marcia R. Cruz-Correa
- Recruiting
Pan American Center for Oncology Trials LLC - Dorado
Dorado, 00646
Site Public Contact, 787-407-3333, info@panoncologytrials.com
Marcia R. Cruz-Correa
- Recruiting
Doctors Cancer Center
Manati, 00674
Site Public Contact, 787-621-4397
Luis J. Santos Reyes
- Recruiting
Pan American Center for Oncology Trials LLC
San Juan, PR, 00680
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Marcia R. Cruz-Correa
- Recruiting
Pan American Center for Oncology Trials LLC
San Juan, 00902
Site Public Contact, 787-407-3333, marcia.cruzcorrea@panoncologytrials.com
Marcia R. Cruz-Correa
- Recruiting
Pan American Center for Oncology Trials LLC - Ciudadela
San Juan, 00909
Site Public Contact, 787-407-3333, info@panoncologytrials.com
Marcia R. Cruz-Correa
- Recruiting
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Site Public Contact, 412-339-5294, Roster@nrgoncology.org
Luis J. Santos Reyes
- Recruiting
PROncology
San Juan, 00927
Site Public Contact, 787-919-7919, info@PRoncology.com
Luis J. Santos Reyes
- Recruiting
San Juan City Hospital
San Juan, 00936
Site Public Contact, 787-763-1296
Luis J. Santos Reyes
About this study
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
Read the detailed description
Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.
- Conditions
- Stage III Colon Cancer
- Being tested
- Signatera test, mFOLFOX6 3-6 month, CAPOX 3 month, mFOLFIRINOX, mFOLFOX6 6 month
- Keywords
- ctDNA positive, ctDNA negative, Adjuvant Chemotherapy, Natera, Signatera, mFOLFOX6, Stage III, CAPOX, mFOLFIRINOX, Oxaliplatin, 5-Fluorouracil (5-FU), Capecitabine, Leucovorin, Irinotecan, Stage II
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signatera testDevice
Central ctDNA testing for all patients
mFOLFOX6 3-6 monthDrug
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles
CAPOX 3 monthDrug
Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles
mFOLFIRINOXDrug
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles
mFOLFOX6 6 monthDrug
Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles
CAPOX 6 monthDrug
Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Arm 1 (ctDNA-ve) | Active comparator | Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles
OR
Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles Receives: Device: Signatera test; Drug: mFOLFOX6 3-6 month; Drug: CAPOX 3 month |
| Cohort A - Arm 2 (ctDNA-ve) | Experimental | Serial ctDNA monitoring no treatment Receives: Device: Signatera test |
| Cohort B - Arm 3 (ctDNA+ve) | Active comparator | Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles
OR
Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles Receives: Device: Signatera test; Drug: mFOLFOX6 6 month; Drug: CAPOX 6 month |
| Cohort B - Arm 4 (ctDNA+ve) | Experimental | Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles Receives: Device: Signatera test; Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA positive status (TTPos)
TTPos is defined as time from randomization until ctDNA positive event: TTPos events are first ctDNA positive result after randomization for the immediate adjuvant chemo arm (Arm 1), 2nd ctDNA positive result after randomization for the delayed adjuvant chemo (Arm 2) and recurrence without a positive ctDNA result for both arms.
Measured: Time from randomization to the first TTPos event, a maximum of 3 years
Disease-Free Survival (DFS)
Time from randomization to first disease-free survival event (recurrence, second primary colorectal cancer or death from any cause).
Measured: Time from randomization to disease-free survival event, a maximum of 5 years]
Secondary outcomes (4)
Baseline post-surgery ctDNA positivity rate
percentage of patients with ctDNA positive results post-surgery at study entry.
Measured: At time of randomization
Overall Survival (OS)
Time from randomization to death of any cause.
Measured: Time from randomization to death, a maximum of 5 years.
Recurrence
Time from randomization to disease recurrence.
Measured: Time from randomization to disease recurrence, a maximum of 5 years
Compliance with adjuvant chemotherapy
number of cycles of chemotherapy received.
Measured: from randomization to the last cycle of chemotherapy, a maximum of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start8 Jul 2022
- Primary completion10 Mar 2029 (estimated)
- Study completion10 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Colon CancerStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,912 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Natera, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174169
- Sponsor's protocol ID
- NRG-GI008
- Other IDs
- U10CA180868, NRG-GI008, NCI-2021-08397
- Acronym
- CIRCULATE-US
- Status last verified
- Nov 2026
- First submitted
- 13 Dec 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
- ClinicalTrials.gov ID
- NCT05174169
- Acronym / sponsor ID
- CIRCULATE-US / NRG-GI008
- Conditions
- Stage III Colon Cancer
- Keywords
- ctDNA positive, ctDNA negative, Adjuvant Chemotherapy, Natera, Signatera, mFOLFOX6, Stage III, CAPOX
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,912 participants (estimated)
- Lead sponsor
- NRG OncologyUniversity, hospital or other
- Collaborators
- Natera, Inc., National Cancer Institute (NCI)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 10 Mar 2029 (estimated)
- Study completion
- 10 Mar 2030 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
Detailed description
Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Arm 1 (ctDNA-ve) | Active comparator | Device: Signatera test, Drug: mFOLFOX6 3-6 month, Drug: CAPOX 3 monthOxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles |
| Cohort A - Arm 2 (ctDNA-ve) | Experimental | Device: Signatera testSerial ctDNA monitoring no treatment |
| Cohort B - Arm 3 (ctDNA+ve) | Active comparator | Device: Signatera test, Drug: mFOLFOX6 6 month, Drug: CAPOX 6 monthOxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles |
| Cohort B - Arm 4 (ctDNA+ve) | Experimental | Device: Signatera test, Drug: mFOLFIRINOXOxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (43 listed)
- The patient must have an ECOG performance status of 0 or 1.
- Patients must have histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria.
- No radiographic evidence of overt metastatic disease within 45 days prior to Step 1/Study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis).
- The distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation).
- The patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible.
Key exclusion criteria (20 listed)
- Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).
- Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.
- Tumor-related bowel perforation.
- History of prior invasive colon malignancy, regardless of disease-free interval.
- History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signatera testCentral ctDNA testing for all patients | Device | Cohort A - Arm 1 (ctDNA-ve), Cohort A - Arm 2 (ctDNA-ve), Cohort B - Arm 3 (ctDNA+ve), Cohort B - Arm 4 (ctDNA+ve) |
| mFOLFOX6 3-6 monthOxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles | Drug | Cohort A - Arm 1 (ctDNA-ve) |
| CAPOX 3 monthOxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles | Drug | Cohort A - Arm 1 (ctDNA-ve) |
| mFOLFIRINOXOxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles | Drug | Cohort B - Arm 4 (ctDNA+ve) |
| mFOLFOX6 6 monthOxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles | Drug | Cohort B - Arm 3 (ctDNA+ve) |
| CAPOX 6 monthOxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles | Drug | Cohort B - Arm 3 (ctDNA+ve) |
Primary outcome
ctDNA positive status (TTPos)
Time frame: Time from randomization to the first TTPos event, a maximum of 3 years
TTPos is defined as time from randomization until ctDNA positive event: TTPos events are first ctDNA positive result after randomization for the immediate adjuvant chemo arm (Arm 1), 2nd ctDNA positive result after randomization for the delayed adjuvant chemo (Arm 2) and recurrence without a positive ctDNA result for both arms.
Disease-Free Survival (DFS)
Time frame: Time from randomization to disease-free survival event, a maximum of 5 years]
Time from randomization to first disease-free survival event (recurrence, second primary colorectal cancer or death from any cause).
4 secondary outcomes
Baseline post-surgery ctDNA positivity rate
Time frame: At time of randomization
Overall Survival (OS)
Time frame: Time from randomization to death, a maximum of 5 years.
Recurrence
Time frame: Time from randomization to disease recurrence, a maximum of 5 years
Compliance with adjuvant chemotherapy
Time frame: from randomization to the last cycle of chemotherapy, a maximum of 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Langer contact
1,085 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Signatera test, mFOLFOX6 3-6 month and CAPOX 3 month in people with Stage III Colon Cancer, run by NRG Oncology at 1,085 sites in 3 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 43 inclusion and 20 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1,085 sites in United States, Canada, Puerto Rico. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Judy Langer (412-339-5300, langerj@nrgoncology.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA positive status (TTPos) (time frame: Time from randomization to the first TTPos event, a maximum of 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?
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 4 Nov 2026.