Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)
Stage III Colon Cancer
About this trial
This is an interventional treatment trial for Stage III Colon Cancer focused on measuring ctDNA positive, ctDNA negative, Adjuvant Chemotherapy, Natera, Signatera, mFOLFOX6, Stage III, CAPOX, mFOLFIRINOX, Oxaliplatin, 5-Fluorouracil (5-FU), Capecitabine, Leucovorin, Irinotecan, Stage II
Eligibility Criteria
Inclusion Criteria:
The patient must have an ECOG performance status of 0 or 1.
Patients must have histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria. NOTE: Patients with pathologic stages II or IIIC colon adenocarcinoma with R0 resection who have a commercially obtained Signatera™ ctDNA+ve assay result post-operatively meeting all timelines and eligibility requirements otherwise, are eligible for enrollment and inclusion in Cohort B.
No radiographic evidence of overt metastatic disease within 28 days prior to 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 IIIA or Stage IIIB colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera.
NOTE: Patients with stage IIIA or IIIB colon cancer who otherwise meet eligibility criteria and have had ctDNA status checked with the Signatera™ assay as routine care outside of the study, are allowed to be enrolled, and will be retested and placed in either Cohort A or Cohort B depending on the central ctDNA testing result.
NOTE: Patients with stage II or IIIC colon cancer who otherwise meet eligibility criteria and have had ctDNA status checked with the Signatera™ assay as routine care outside of the study AND have a ctDNA+ve result, are allowed to be enrolled. Patients will have central ctDNA testing, confirmed to be ctDNA+ve, and placed in Cohort B.
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 study entry must be no more than 60 days.
Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.
Adequate hematologic function within 28 days before study entry defined as follows:
- Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
- 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 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 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)
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 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 study entry must be negative (for women of childbearing potential only).
Adequate hematologic function within 28 days before randomization defined as follows:
- Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
- 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 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 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)
Exclusion Criteria:
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).
Other invasive malignancy within 5 years before 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 UGT1A1*28 polymorphism.
Pregnancy or lactation at the time of 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.
Sites / Locations
- Thomas HospitalRecruiting
- Mobile Infirmary Medical CenterRecruiting
- University of South Alabama Mitchell Cancer InstituteRecruiting
- Kingman Regional Medical CenterRecruiting
- Cancer Center at Saint Joseph'sRecruiting
- Mayo Clinic Hospital in Arizona
- Mercy Hospital Fort SmithRecruiting
- CHI Saint Vincent Cancer Center Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroRecruiting
- University of Arkansas for Medical SciencesRecruiting
- Kaiser Permanente-AnaheimRecruiting
- Kaiser Permanente-Deer Valley Medical CenterRecruiting
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- PCR OncologyRecruiting
- AIS Cancer Center at San Joaquin Community HospitalRecruiting
- Kaiser Permanente-Baldwin ParkRecruiting
- Kaiser Permanente-BellflowerRecruiting
- Tower Cancer Research FoundationRecruiting
- Marshall Cancer CenterRecruiting
- Mercy Cancer Center �� CarmichaelRecruiting
- Mercy San Juan Medical CenterRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Epic Care-DublinRecruiting
- Kaiser Permanente DublinRecruiting
- Mercy Cancer Center - Elk GroveRecruiting
- Epic Care Partners in Cancer CareRecruiting
- Kaiser Permanente-FontanaRecruiting
- Orange Coast Memorial Medical CenterRecruiting
- Kaiser Permanente-FremontRecruiting
- Washington HospitalRecruiting
- Kaiser Permanente-FresnoRecruiting
- Kaiser Permanente - Harbor CityRecruiting
- City of Hope at Irvine LennarRecruiting
- Kaiser Permanente-IrvineRecruiting
- Saddleback Memorial Medical CenterRecruiting
- UCI Health Laguna HillsRecruiting
- City of Hope Antelope ValleyRecruiting
- Loma Linda University Medical CenterRecruiting
- Long Beach Memorial Medical Center-Todd Cancer InstituteRecruiting
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Kaiser Permanente West Los AngelesRecruiting
- Cedars Sinai Medical CenterRecruiting
- Contra Costa Regional Medical CenterRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- Kaiser Permanente-ModestoRecruiting
- Bay Area Tumor InstituteRecruiting
- Kaiser Permanente-OaklandRecruiting
- Kaiser Permanente-OntarioRecruiting
- Saint Joseph Hospital - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Kaiser Permanente - Panorama CityRecruiting
- Kaiser Permanente- Marshall Medical OfficesRecruiting
- Kaiser Permanente-RichmondRecruiting
- Kaiser Permanente-RiversideRecruiting
- Mercy Cancer Center - RocklinRecruiting
- Kaiser Permanente-RosevilleRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- Mercy Cancer Center - SacramentoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-South SacramentoRecruiting
- Kaiser Permanente-San Diego ZionRecruiting
- Kaiser Permanente-San FranciscoRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Kaiser Permanente San LeandroRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Kaiser Permanente-San MarcosRecruiting
- Kaiser San Rafael-GallinasRecruiting
- Kaiser Permanente Medical Center - Santa ClaraRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Kaiser Permanente-Santa RosaRecruiting
- City of Hope South PasadenaRecruiting
- Kaiser Permanente-South San FranciscoRecruiting
- Kaiser Permanente-StocktonRecruiting
- City of Hope South BayRecruiting
- Gene Upshaw Memorial Tahoe Forest Cancer CenterRecruiting
- City of Hope UplandRecruiting
- Kaiser Permanente Medical Center-VacavilleRecruiting
- Kaiser Permanente-VallejoRecruiting
- Kaiser Permanente-Walnut CreekRecruiting
- Epic Care Cyberknife CenterRecruiting
- Kaiser Permanente-Woodland HillsRecruiting
- Woodland Memorial HospitalRecruiting
- University of Colorado HospitalRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- UCHealth Memorial Hospital CentralRecruiting
- Memorial Hospital NorthRecruiting
- Saint Francis Cancer CenterRecruiting
- Kaiser Permanente-FranklinRecruiting
- UCHealth - Cherry CreekRecruiting
- Porter Adventist HospitalRecruiting
- Mercy Medical CenterRecruiting
- Southwest Oncology PCRecruiting
- Shaw Cancer CenterRecruiting
- Poudre Valley HospitalRecruiting
- Cancer Care and Hematology-Fort CollinsRecruiting
- UCHealth Greeley HospitalRecruiting
- UCHealth Highlands Ranch HospitalRecruiting
- Kaiser Permanente-Rock CreekRecruiting
- Saint Anthony HospitalRecruiting
- Littleton Adventist HospitalRecruiting
- Kaiser Permanente-Lone TreeRecruiting
- UCHealth Lone Tree Health CenterRecruiting
- Longmont United HospitalRecruiting
- Rocky Mountain Cancer Centers-Longmont
- Medical Center of the RockiesRecruiting
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical CenterRecruiting
- Smilow Cancer Hospital-Derby Care CenterRecruiting
- Smilow Cancer Hospital Care Center-FairfieldRecruiting
- Smilow Cancer Hospital Care Center at GlastonburyRecruiting
- Smilow Cancer Hospital Care Center at GreenwichRecruiting
- Smilow Cancer Hospital Care Center - GuilfordRecruiting
- Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
- Smilow Cancer Center/Yale-New Haven HospitalRecruiting
- Yale UniversityRecruiting
- Yale-New Haven Hospital North Haven Medical CenterRecruiting
- Smilow Cancer Hospital-Orange Care CenterRecruiting
- Smilow Cancer Hospital Care Center at Long RidgeRecruiting
- Smilow Cancer Hospital-Torrington Care CenterRecruiting
- Smilow Cancer Hospital Care Center-TrumbullRecruiting
- Smilow Cancer Hospital-Waterbury Care CenterRecruiting
- Smilow Cancer Hospital Care Center - WaterfordRecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Kaiser Permanente-Capitol Hill Medical CenterRecruiting
- MedStar Georgetown University HospitalRecruiting
- MedStar Washington Hospital CenterRecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- Jupiter Medical CenterRecruiting
- AdventHealth OrlandoRecruiting
- Moffitt Cancer Center-International PlazaRecruiting
- Moffitt Cancer Center - McKinley CampusRecruiting
- Moffitt Cancer CenterRecruiting
- University Cancer and Blood Center LLCRecruiting
- Piedmont HospitalRecruiting
- Piedmont Fayette HospitalRecruiting
- Piedmont Newnan HospitalRecruiting
- Piedmont Henry HospitalRecruiting
- Hawaii Cancer Care - WestridgeRecruiting
- Pali Momi Medical CenterRecruiting
- Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
- Queen's Cancer Cenrer - POB IRecruiting
- Queen's Medical CenterRecruiting
- Straub Clinic and HospitalRecruiting
- University of Hawaii Cancer CenterRecruiting
- Queen's Cancer Center - KuakiniRecruiting
- Kaiser Permanente Moanalua Medical CenterRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer ClinicRecruiting
- Saint Anthony's HealthRecruiting
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Northwestern UniversityRecruiting
- University of IllinoisRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Elmhurst Memorial HospitalRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Ingalls Memorial HospitalRecruiting
- Edward Hines Jr VA HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Trinity Medical CenterRecruiting
- Good Samaritan Regional Health CenterRecruiting
- Edward Hospital/Cancer CenterRecruiting
- UC Comprehensive Cancer Center at Silver CrossRecruiting
- Cancer Care Center of O'FallonRecruiting
- University of Chicago Medicine-Orland ParkRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Edward Hospital/Cancer Center?PlainfieldRecruiting
- Illinois CancerCare-PrincetonRecruiting
- SwedishAmerican Regional Cancer Center/ACTRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare CenterRecruiting
- Northwest Cancer Center - Main CampusRecruiting
- Northwest Oncology LLCRecruiting
- Parkview Regional Medical CenterRecruiting
- Northwest Cancer Center - HobartRecruiting
- Saint Mary Medical CenterRecruiting
- Saint Catherine HospitalRecruiting
- The Community HospitalRecruiting
- Women's Diagnostic Center - MunsterRecruiting
- Reid HealthRecruiting
- Northwest Cancer Center - ValparaisoRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic PC - AmesRecruiting
- University of Iowa Healthcare Cancer Services Quad CitiesRecruiting
- McFarland Clinic PC-BooneRecruiting
- Mercy HospitalRecruiting
- Oncology Associates at Mercy Medical CenterRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Alegent Health Mercy HospitalRecruiting
- Greater Regional Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- McFarland Clinic PC-Trinity Cancer CenterRecruiting
- University of Iowa/Holden Comprehensive Cancer CenterRecruiting
- McFarland Clinic PC-JeffersonRecruiting
- McFarland Clinic PC-MarshalltownRecruiting
- Siouxland Regional Cancer CenterRecruiting
- Mercy Medical Center-West LakesRecruiting
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- Cancer Center of Kansas-Wichita Medical Arts TowerRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- Flaget Memorial HospitalRecruiting
- Commonwealth Cancer Center-CorbinRecruiting
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- Saint Joseph LondonRecruiting
- Jewish Hospital
- Norton Hospital Pavilion and Medical CampusRecruiting
- Saints Mary and Elizabeth Hospital
- Norton Audubon Hospital and Medical CampusRecruiting
- Norton Brownsboro Hospital and Medical CampusRecruiting
- UofL Health Medical Center Northeast
- Jewish Hospital Medical Center South
- LSU Health Baton Rouge-North ClinicRecruiting
- Our Lady of the Lake Physicians Group - Medical OncologyRecruiting
- Ochsner Hematology Oncology North Shore - Covington (West Region)Recruiting
- West Jefferson Medical CenterRecruiting
- Louisiana State University Health Science CenterRecruiting
- University Medical Center New OrleansRecruiting
- Ochsner Medical Center JeffersonRecruiting
- Harold Alfond Center for Cancer CareRecruiting
- MaineHealth/SMHC Cancer Care and Blood Disorders-BiddefordRecruiting
- MaineHealth/SMHC Cancer Care and Blood Disorders-SanfordRecruiting
- Maine Medical Partners - South PortlandRecruiting
- Greater Baltimore Medical CenterRecruiting
- Sinai Hospital of BaltimoreRecruiting
- Saint Agnes HospitalRecruiting
- MedStar Franklin Square Medical Center/Weinberg Cancer InstituteRecruiting
- MedStar Good Samaritan HospitalRecruiting
- Kaiser Permanente-Woodlawn Medical CenterRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- UPMC Western MarylandRecruiting
- Kaiser Permanente-Gaithersburg Medical CenterRecruiting
- UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
- Kaiser Permanente - Largo Medical CenterRecruiting
- Kaiser Permanente Lutherville - Timonium Medical CenterRecruiting
- William E Kahlert Regional Cancer Center/Sinai HospitalRecruiting
- Tufts Medical CenterRecruiting
- Steward Saint Elizabeth's Medical CenterRecruiting
- Dana-Farber Cancer Institute at FoxboroughRecruiting
- Dana Farber-Merrimack ValleyRecruiting
- Dana-Farber/Brigham and Women's Cancer Center at Milford RegionalRecruiting
- Dana-Farber/Brigham and Women's Cancer Center at South ShoreRecruiting
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Bronson Battle CreekRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer CenterRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-ClarkstonRecruiting
- Newland Medical Associates-ClarkstonRecruiting
- Beaumont Hospital - DearbornRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Sparrow HospitalRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- Trinity Health Muskegon HospitalRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Ascension Providence Hospitals - NoviRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer CenterRecruiting
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Spectrum Health Reed City HospitalRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Marie Yeager Cancer CenterRecruiting
- Ascension Providence Hospitals - SouthfieldRecruiting
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- William Beaumont Hospital - TroyRecruiting
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- University of Michigan Health - WestRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - BurnsvilleRecruiting
- Cambridge Medical CenterRecruiting
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity HospitalRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- New Ulm Medical CenterRecruiting
- Fairview Northland Medical CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud HospitalRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Sanford Thief River Falls Medical CenterRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Sanford Cancer Center WorthingtonRecruiting
- Fairview Lakes Medical CenterRecruiting
- Baptist Memorial Hospital and Cancer Center-Golden TriangleRecruiting
- Baptist Cancer Center-GrenadaRecruiting
- Baptist Memorial Hospital and Cancer Center-Union CountyRecruiting
- Baptist Memorial Hospital and Cancer Center-OxfordRecruiting
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Cox Cancer Center BransonRecruiting
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- University of Missouri - Ellis FischelRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Mercy Hospital SouthRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital WashingtonRecruiting
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls ClinicRecruiting
- Kalispell Regional Medical CenterRecruiting
- Community Medical HospitalRecruiting
- CHI Health Saint Francis
- CHI Health Good SamaritanRecruiting
- Saint Elizabeth Regional Medical CenterRecruiting
- Alegent Health Immanuel Medical CenterRecruiting
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- Midlands Community HospitalRecruiting
- Carson Tahoe Regional Medical CenterRecruiting
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- OptumCare Cancer Care at Seven HillsRecruiting
- OptumCare Cancer Care at CharlestonRecruiting
- Comprehensive Cancer Centers of NevadaRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- New Hampshire Oncology Hematology PA-ConcordRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- The Dana-Farber Cancer Institute at LondonderryRecruiting
- Solinsky Center for Cancer CareRecruiting
- Trinitas Hospital and Comprehensive Cancer Center - Williamson Street CampusRecruiting
- The Cancer Institute of New Jersey HamiltonRecruiting
- Jersey City Medical CenterRecruiting
- Monmouth Medical Center Southern CampusRecruiting
- Saint Barnabas Medical CenterRecruiting
- Monmouth Medical CenterRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Rutgers New Jersey Medical SchoolRecruiting
- Newark Beth Israel Medical CenterRecruiting
- Robert Wood Johnson University Hospital SomersetRecruiting
- Community Medical CenterRecruiting
- University of New Mexico Cancer CenterRecruiting
- Presbyterian Kaseman HospitalRecruiting
- Memorial Medical Center - Las CrucesRecruiting
- Presbyterian Rust Medical Center/Jorgensen Cancer CenterRecruiting
- Montefiore Medical Center-Einstein CampusRecruiting
- New York-Presbyterian/Brooklyn Methodist HospitalRecruiting
- The New York Hospital Medical Center of QueensRecruiting
- Queens Medical Associates PCRecruiting
- Glens Falls HospitalRecruiting
- Northwell Health Cancer Institute at HuntingtonRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Garnet Health Medical CenterRecruiting
- NYU Winthrop HospitalRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- Mount Sinai WestRecruiting
- Lenox Hill HospitalRecruiting
- Mount Sinai HospitalRecruiting
- Manhattan Eye Ear and Throat HospitalRecruiting
- NYP/Weill Cornell Medical CenterRecruiting
- University of RochesterRecruiting
- Stony Brook University Medical CenterRecruiting
- Wilmot Cancer Institute at WebsterRecruiting
- Duke Cancer Institute CaryRecruiting
- Rex Hematology Oncology Associates-CaryRecruiting
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Southeastern Medical Oncology Center-ClintonRecruiting
- Duke University Medical CenterRecruiting
- Rex Hematology Oncology Associates-GarnerRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Margaret R Pardee Memorial HospitalRecruiting
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- UNC Rex HealthcareRecruiting
- Duke Raleigh HospitalRecruiting
- UNC Rex Cancer Center of WakefieldRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Summa Health System - Akron CampusRecruiting
- Cleveland Clinic Akron GeneralRecruiting
- UH Seidman Cancer Center at UH Avon Health CenterRecruiting
- Summa Health System - Barberton CampusRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Strecker Cancer Center-BelpreRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Geauga HospitalRecruiting
- Adena Regional Medical CenterRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- Good Samaritan Hospital - CincinnatiRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Bethesda North HospitalRecruiting
- TriHealth Cancer Institute-WestsideRecruiting
- TriHealth Cancer Institute-AndersonRecruiting
- Case Western Reserve UniversityRecruiting
- MetroHealth Medical CenterRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Mount Carmel East HospitalRecruiting
- Columbus Oncology and Hematology Associates IncRecruiting
- Riverside Methodist HospitalRecruiting
- Grant Medical CenterRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Doctors HospitalRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Delaware Health Center-Grady Cancer CenterRecruiting
- Grady Memorial HospitalRecruiting
- Columbus Oncology and Hematology AssociatesRecruiting
- Dublin Methodist HospitalRecruiting
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Central Ohio Breast and Endocrine SurgeryRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Wayne HospitalRecruiting
- Mount Carmel Grove City HospitalRecruiting
- Cleveland Clinic Cancer Center IndependenceRecruiting
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- Fairfield Medical CenterRecruiting
- Saint Rita's Medical CenterRecruiting
- OhioHealth Mansfield HospitalRecruiting
- Cleveland Clinic Cancer Center MansfieldRecruiting
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General HospitalRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- Summa Health Medina Medical CenterRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- UH Seidman Cancer Center at Southwest General HospitalRecruiting
- Knox Community HospitalRecruiting
- Mount Carmel New Albany Surgical HospitalRecruiting
- Licking Memorial HospitalRecruiting
- Newark Radiation OncologyRecruiting
- University Hospitals Parma Medical CenterRecruiting
- Mercy Health Perrysburg Cancer CenterRecruiting
- Southern Ohio Medical CenterRecruiting
- University Hospitals Portage Medical CenterRecruiting
- North Coast Cancer CareRecruiting
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical CenterRecruiting
- Trinity's Tony Teramana Cancer CenterRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- Saint Vincent Mercy Medical CenterRecruiting
- Mercy Health - Saint Anne HospitalRecruiting
- Dayton Physicians LLC - TroyRecruiting
- University Hospitals Sharon Health CenterRecruiting
- South Pointe HospitalRecruiting
- Saint Joseph Warren HospitalRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- Saint Ann's HospitalRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Oklahoma Cancer Specialists and Research Institute-TulsaRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Kaiser Permanente NorthwestRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- UPMC AltoonaRecruiting
- UPMC-Heritage Valley Health System BeaverRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- UPMC Hillman Cancer Center at Butler Health SystemRecruiting
- UPMC Camp HillRecruiting
- Carlisle Regional Cancer CenterRecruiting
- UPMC Hillman Cancer Center - Passavant - CranberryRecruiting
- Pocono Medical CenterRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- UPMC Cancer Center at UPMC HorizonRecruiting
- UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
- Lehigh Valley Hospital-HazletonRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- IRMC Cancer CenterRecruiting
- UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
- UPMC Cancer Center at UPMC McKeesportRecruiting
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
- UPMC Hillman Cancer Center - MonroevilleRecruiting
- UPMC Hillman Cancer Center in CoraopolisRecruiting
- Arnold Palmer Cancer Center Medical Oncology NorwinRecruiting
- UPMC Cancer Center-Natrona HeightsRecruiting
- UPMC Hillman Cancer Center - New CastleRecruiting
- Thomas Jefferson University HospitalRecruiting
- Fox Chase Cancer Center
- Jefferson Methodist HospitalRecruiting
- UPMC-Presbyterian HospitalRecruiting
- UPMC-Saint MargaretRecruiting
- UPMC-Mercy HospitalRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Shadyside HospitalRecruiting
- UPMC-Passavant HospitalRecruiting
- UPMC-Saint Clair Hospital Cancer CenterRecruiting
- UPMC Cancer Center at UPMC NorthwestRecruiting
- UPMC Cancer Center-UniontownRecruiting
- UPMC Cancer Center-WashingtonRecruiting
- Divine Providence HospitalRecruiting
- Asplundh Cancer PavilionRecruiting
- UPMC MemorialRecruiting
- Smilow Cancer Hospital Care Center - WesterlyRecruiting
- Avera Cancer Institute-AberdeenRecruiting
- Avera Cancer Institute at PierreRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Baptist Memorial Hospital and Cancer Center-ColliervilleRecruiting
- The West Clinic - Wolf RiverRecruiting
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Dell Seton Medical Center at The University of TexasRecruiting
- University of Texas at AustinRecruiting
- Saint Joseph Regional Cancer Center
- STCC at DHR Health Institute for Research and DevelopmentRecruiting
- University of Texas Medical BranchRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- Ben Taub General HospitalRecruiting
- M D Anderson Cancer CenterRecruiting
- Farmington Health CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- South Jordan Health CenterRecruiting
- Central Vermont Medical Center/National Life Cancer TreatmentRecruiting
- University of Vermont Medical CenterRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Kaiser Permanente-Burke Medical CenterRecruiting
- Cancer Specialists of Tidewater LimitedRecruiting
- Peninsula Cancer Institute-GloucesterRecruiting
- Centra Lynchburg Hematology-Oncology Clinic IncRecruiting
- Kaiser Permanente Tysons Corner Medical CenterRecruiting
- Peninsula Cancer Institute-Newport NewsRecruiting
- Virginia Cancer InstituteRecruiting
- VCU Massey Cancer Center at Stony PointRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- VCU Community Memorial Health CenterRecruiting
- Cancer Specialists of Tidewater-SuffolkRecruiting
- Peninsula Cancer Institute-Cancer Specialists of TidewaterRecruiting
- Peninsula Cancer Institute-WilliamsburgRecruiting
- Harrison Medical CenterRecruiting
- Highline Medical Center-Main Campus
- Saint Elizabeth Hospital
- Saint Francis Hospital
- Saint Clare Hospital
- Valley Medical CenterRecruiting
- Franciscan Research Center-Northwest Medical Plaza
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- WVUH-Berkely Medical CenterRecruiting
- West Virginia University HealthcareRecruiting
- Camden Clark Medical CenterRecruiting
- Wheeling Hospital/Schiffler Cancer CenterRecruiting
- ThedaCare Regional Cancer CenterRecruiting
- ThedaCare Cancer Care - BerlinRecruiting
- HSHS Sacred Heart HospitalRecruiting
- Mayo Clinic Health System-Eau Claire Clinic
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- Mayo Clinic Health System-Franciscan Healthcare
- University of Wisconsin Carbone Cancer CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Saint Vincent Hospital Cancer Center at Oconto FallsRecruiting
- ThedaCare Cancer Care - ShawanoRecruiting
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- UW Cancer Center at ProHealth CareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Active Comparator
Experimental
Cohort A - Arm 1 (ctDNA-ve)
Cohort A - Arm 2 (ctDNA-ve)
Cohort B - Arm 3 (ctDNA+ve)
Cohort B - Arm 4 (ctDNA+ve)
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
Serial ctDNA monitoring no treatment
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
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