Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery
Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v8
About this trial
This is an interventional treatment trial for Colon Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically/pathologically confirmed stage IIA adenocarcinoma of the colon (T3, N0, M0) with at least 12 lymph nodes examined at the time of surgical resection.
- Appropriate for active surveillance (i.e., no adjuvant chemotherapy) at the discretion of and as documented by the evaluating oncologist based on current practice patterns.
- The distal extent of the tumor must be >= 12 cm from the anal verge on pre-surgical endoscopy (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). If the patient did not undergo a pre-surgical endoscopy, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination or pre-operative imaging.
- The patient must have had an en bloc complete gross resection of tumor (curative resection) as definitive surgical cancer treatment within 14 to 60 days of study randomization. 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.
- Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.
- Absolute neutrophil count (ANC) must be >= 1200/mm^3 (within 28 days before randomization).
- Platelet count must be >= 100,000/mm^3 (within 28 days before randomization); and
- Hemoglobin must be >= 9 g/dL (within 28 days before randomization).
- Total bilirubin must be =< ULN (upper limit of normal) for the lab (within 28 days before randomization) unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert?s disease or similar syndrome involving slow conjugation of bilirubin; and
- Alkaline phosphatase must be < 2.5 x ULN for the lab (within 28 days before randomization); and
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 1.5 x ULN for the lab (within 28 days before randomization).
- Serum creatinine =< 1.5 x ULN for the lab or measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab (within 28 days before randomization).
- Pregnancy test (urine or serum according to institutional standard) done within 14 days before randomization must be negative (for women of childbearing potential only).
- Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of international normalized ratio (INR) if they are randomized to Arm 2 and receive capecitabine.
Exclusion Criteria:
- Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).
- Pathologic, clinical, or radiologic evidence of overt metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected (including the presence of satellite nodules constituting N1c disease in the absence of lymph node involvement).
- Tumor-related bowel perforation.
- History of prior invasive colon malignancy, regardless of disease-free interval.
- History of organ transplantation.
- Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary rectal adenocarcinomas for which treatment with neoadjuvant chemoradiation is warranted are not permitted).
- Other invasive malignancy within 5 years before randomization. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ including those of the cervix and breast (DCIS).
- Synchronous primary rectal and/or colon cancers.
- Antineoplastic therapy (e.g., chemotherapy, targeted therapy, or immunotherapy) within 5 years before randomization. (For the purposes of this study, hormonal therapy is not considered chemotherapy.).
Uncontrolled cardiac disease, in the opinion of the treating medical oncologist, that would preclude the use of any of the drugs included in the GI005 treatment regimen. This includes but is not limited to:
- Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker.
- Ventricular tachycardia or supraventricular tachycardia that requires treatment with class Ia antiarrhythmic drugs (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted.
- Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker.
- Complete left bundle branch block (LBBB) unless treated with a permanent pacemaker.
- Sensory or motor neuropathy >= grade 2, according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
- Active seizure disorder uncontrolled by medication.
- Active or chronic infection requiring systemic therapy.
- Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.
- Pregnancy or lactation at the time of randomization.
- Co-morbid illnesses or other concurrent disease that, in the judgement of the clinician obtaining informed consent, 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).
- Prior testing with any available ctDNA test as part of the management of colon cancer.
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- University of South Alabama Mitchell Cancer Institute
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Kingman Regional Medical Center
- Cancer Center at Saint Joseph's
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- Kaiser Permanente-Anaheim
- Mission Hope Medical Oncology - Arroyo Grande
- PCR Oncology
- Sutter Auburn Faith Hospital
- Kaiser Permanente-Baldwin Park
- Kaiser Permanente-Bellflower
- UCSF Cancer Center - Berkeley
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Marshall Cancer Center
- Mercy Cancer Center �� Carmichael
- Mercy San Juan Medical Center
- Eden Hospital Medical Center
- Enloe Medical Center
- UC Irvine Health Cancer Center-Newport
- Sutter Davis Hospital
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Mercy Cancer Center - Elk Grove
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fontana
- Palo Alto Medical Foundation-Fremont
- Kaiser Permanente - Harbor City
- Kaiser Permanente-Irvine
- Keck Medicine of USC Koreatown
- Kaiser Permanente Los Angeles Medical Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente West Los Angeles
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Providence Queen of The Valley
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Kaiser Permanente-Ontario
- Saint Joseph Hospital - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente - Panorama City
- Kaiser Permanente-Riverside
- Mercy Cancer Center - Rocklin
- Sutter Roseville Medical Center
- Mercy Cancer Center - Sacramento
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Salinas Valley Memorial
- Kaiser Permanente-San Diego Mission
- Kaiser Permanente-San Diego Zion
- California Pacific Medical Center-Pacific Campus
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente-San Marcos
- UCSF Cancer Center - San Mateo
- Palo Alto Medical Foundation-Santa Cruz
- Mission Hope Medical Oncology - Santa Maria
- Providence Medical Foundation - Santa Rosa
- Sutter Pacific Medical Foundation
- Providence Santa Rosa Memorial Hospital
- City of Hope South Pasadena
- Palo Alto Medical Foundation-Sunnyvale
- City of Hope South Bay
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- City of Hope Upland
- Sutter Solano Medical Center/Cancer Center
- Epic Care Cyberknife Center
- Kaiser Permanente-Woodland Hills
- Woodland Memorial Hospital
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- UCHealth University of Colorado Hospital
- Boulder Community Foothills Hospital
- Rocky Mountain Cancer Centers-Boulder
- Rocky Mountain Cancer Centers - Centennial
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Memorial Hospital North
- Saint Francis Cancer Center
- Kaiser Permanente-Franklin
- The Women's Imaging Center
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Rocky Mountain Cancer Centers - Swedish
- Swedish Medical Center
- The Melanoma and Skin Cancer Institute
- Poudre Valley Hospital
- Cancer Care and Hematology-Fort Collins
- SCL Health Cancer Centers of Colorado - Lutheran Medical Center
- North Colorado Medical Center
- UCHealth Greeley Hospital
- Kaiser Permanente-Rock Creek
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Kaiser Permanente-Lone Tree
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- Medical Center of the Rockies
- Parker Adventist Hospital
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers-Thornton
- Danbury Hospital
- Smilow Cancer Hospital-Derby Care Center
- Smilow Cancer Hospital Care Center-Fairfield
- Smilow Cancer Hospital Care Center at Greenwich
- Smilow Cancer Hospital Care Center - Guilford
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Midstate Medical Center
- The Hospital of Central Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Yale-New Haven Hospital North Haven Medical Center
- Norwalk Hospital
- Smilow Cancer Hospital-Orange Care Center
- Smilow Cancer Hospital-Torrington Care Center
- Smilow Cancer Hospital Care Center-Trumbull
- Smilow Cancer Hospital-Waterbury Care Center
- Smilow Cancer Hospital Care Center - Waterford
- Beebe South Coastal Health Campus
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Beebe Health Campus
- Kaiser Permanente-Capitol Hill Medical Center
- MedStar Washington Hospital Center
- Holy Cross HospitalRecruiting
- University of Florida Health Science Center - Gainesville
- AdventHealth Orlando
- Orlando Health Cancer Institute
- Memorial Hospital West
- Cleveland Clinic-Weston
- University Cancer and Blood Center LLC
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Augusta Oncology Associates PC-D'Antignac
- Augusta Oncology Associates PC-Wheeler
- Northeast Georgia Medical Center-Gainesville
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Queen's Cancer Center - Kuakini
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Rush - Copley Medical Center
- Advocate Good Shepherd Hospital
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- Rush University Medical Center
- University of Illinois
- Advocate Illinois Masonic Medical Center
- AMG Crystal Lake - Oncology
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Northwestern Medicine Cancer Center Kishwaukee
- Illinois CancerCare-Dixon
- Advocate Good Samaritan Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Advocate Sherman Hospital
- Elmhurst Memorial Hospital
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- Ingalls Memorial Hospital
- Advocate South Suburban Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Edward Hines Jr VA Hospital
- Illinois CancerCare-Kewanee Clinic
- AMG Libertyville - Oncology
- Condell Memorial Hospital
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- Edward Hospital/Cancer Center
- Cancer Care Center of O'Fallon
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Advocate Lutheran General Hospital
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Edward Hospital/Cancer Center?Plainfield
- Illinois CancerCare-Princeton
- West Suburban Medical Center
- Genesis Cancer Center - Silvis
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Illinois CancerCare - Washington
- Rush-Copley Healthcare Center
- IU Health North Hospital
- Northwest Cancer Center - Main Campus
- Northwest Oncology LLC
- Goshen Center for Cancer Care
- Northwest Cancer Center - Hobart
- Saint Mary Medical Center
- Indiana University/Melvin and Bren Simon Cancer Center
- Franciscan Health Indianapolis
- Saint Catherine Hospital
- Franciscan Health Mooresville
- The Community Hospital
- Women's Diagnostic Center - Munster
- Reid Health
- Memorial Hospital of South Bend
- Union Hospital
- Northwest Cancer Center - Valparaiso
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- University of Iowa Healthcare Cancer Services Quad Cities
- McFarland Clinic - Boone
- Physicians' Clinic of Iowa PC
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Genesis Medical Center - East Campus
- Genesis Cancer Care Institute
- Iowa Cancer Specialists
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer Center
- Trinity Regional Medical Center
- University of Iowa/Holden Comprehensive Cancer Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- University of Kansas Clinical Research Center
- HaysMed University of Kansas Health System
- University of Kansas Cancer Center-West
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- University of Kansas Health System Saint Francis Campus
- University of Kansas Hospital-Westwood Cancer Center
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Baptist Health Lexington
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Saint Joseph London
- Jewish Hospital
- Baptist Health Louisville
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Jewish Hospital Medical Center South
- LSU Health Baton Rouge-North Clinic
- Our Lady of The Lake
- Louisiana Hematology Oncology Associates LLC
- Mary Bird Perkins Cancer Center
- Our Lady of the Lake Physicians Group - Medical Oncology
- Northshore Oncology Associates-Covington
- Terrebonne General Medical Center
- Ochsner Medical Center Jefferson
- Harold Alfond Center for Cancer Care
- Waldo County General Hospital
- MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
- Lafayette Family Cancer Center-EMMC
- Penobscot Bay Medical Center
- MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
- Maine Medical Partners - South Portland
- Greater Baltimore Medical Center
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- MedStar Good Samaritan Hospital
- Kaiser Permanente-Woodlawn Medical Center
- UM Upper Chesapeake Medical Center
- UPMC Western Maryland
- University of Maryland Shore Medical Center at Easton
- FMH James M Stockman Cancer Institute
- Kaiser Permanente-Gaithersburg Medical Center
- UM Baltimore Washington Medical Center/Tate Cancer Center
- Kaiser Permanente - Largo Medical Center
- Kaiser Permanente Lutherville - Timonium Medical Center
- UMass Memorial Medical Center - University Campus
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- McLaren Cancer Institute-Bay City
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Hematology Oncology Consultants-Clarkston
- McLaren Cancer Institute-Clarkston
- Newland Medical Associates-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Weisberg Cancer Treatment Center
- Beaumont Hospital - Farmington Hills
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Mid-Michigan Physicians-Lansing
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer Region
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton Shores
- Henry Ford Medical Center-Columbus
- McLaren Cancer Institute-Northern Michigan
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- McLaren-Port Huron
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Henry Ford Macomb Health Center - Shelby Township
- Ascension Providence Hospitals - Southfield
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Munson Medical Center
- William Beaumont Hospital - Troy
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- University of Michigan Health - West
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Cambridge Medical Center
- Mercy Hospital
- Essentia Health Cancer Center
- Fairview Southdale Hospital
- Unity Hospital
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Coborn Cancer Center at Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
- Baptist Cancer Center-Grenada
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Baptist Memorial Hospital and Cancer Center-Desoto
- Saint Louis Cancer and Breast Institute-Ballwin
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Truman Medical Centers
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- Carson Tahoe Regional Medical Center
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- Las Vegas Urology - Green Valley
- Las Vegas Urology - Pebble
- Urology Specialists of Nevada - Green Valley
- Las Vegas Urology - Pecos
- Desert West Surgery
- OptumCare Cancer Care at Charleston
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Radiation Oncology Centers of Nevada Central
- Urology Specialists of Nevada - Central
- GenesisCare USA - Las Vegas
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Las Vegas Prostate Cancer Center
- Las Vegas Urology - Sunset
- Urology Specialists of Nevada - Southwest
- Radiation Oncology Centers of Nevada Southeast
- Ann M Wierman MD LTD
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Las Vegas Urology - Cathedral Rock
- Las Vegas Urology - Smoke Ranch
- OptumCare Cancer Care at MountainView
- Urology Specialists of Nevada - Northwest
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- New Hampshire Oncology Hematology PA-Concord
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Solinsky Center for Cancer Care
- Cooper Hospital University Medical Center
- The Cancer Institute of New Jersey Hamilton
- Saint Barnabas Medical Center
- Monmouth Medical Center
- Rutgers Cancer Institute of New Jersey
- The Valley Hospital-Luckow Pavilion
- Valley Hospital
- Robert Wood Johnson University Hospital Somerset
- Holy Name Hospital
- Community Medical Center
- MD Anderson Cancer Center at Cooper-Voorhees
- Valley Medical Group - Wayne Multispecialty Practice
- Valley Health System-Hematology/Oncology
- University of New Mexico Cancer Center
- Presbyterian Kaseman Hospital
- Memorial Medical Center - Las Cruces
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
- Saint Peter's Health Partners
- Hematology Oncology Associates of Central New York-Auburn
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Hematology Oncology Associates of Central New York-East Syracuse
- Glens Falls Hospital
- Northwell Health/Center for Advanced Medicine
- Mount Sinai West
- Lenox Hill Hospital
- Mount Sinai Hospital
- Manhattan Eye Ear and Throat Hospital
- Phelps Memorial Hospital Center
- Staten Island University Hospital
- Stony Brook University Medical Center
- Hematology Oncology Associates of Central New York-Onondaga Hill
- Saint Marys Hospital-Troy
- Atrium Health Stanly/LCI-Albemarle
- AdventHealth Infusion Center Asheville
- Duke Cancer Institute Cary
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Atrium Health Pineville/LCI-Pineville
- Levine Cancer Institute-SouthPark
- Atrium Health University City/LCI-University
- Levine Cancer Institute-Ballantyne
- Wake Forest University at Clemmons
- Southeastern Medical Oncology Center-Clinton
- AdventHealth Infusion Center Haywood
- Atrium Health Cabarrus/LCI-Concord
- Duke University Medical Center
- CaroMont Regional Medical Center
- Levine Cancer Institute-Gaston
- Southeastern Medical Oncology Center-Goldsboro
- Margaret R Pardee Memorial Hospital
- AdventHealth Hendersonville
- Southeastern Medical Oncology Center-Jacksonville
- Atrium Health Lincoln/LCI-Lincolnton
- Atrium Health Union/LCI-Union
- Duke Raleigh Hospital
- Marion L Shepard Cancer Center at Vidant Beaufort Hospital
- AdventHealth Infusion Center Weaverville
- Wake Forest Baptist Health - Wilkes Medical Center
- Wake Forest University Health SciencesRecruiting
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Altru Cancer Center
- Cleveland Clinic Akron General
- UHHS-Chagrin Highlands Medical Center
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-Belpre
- Saint Elizabeth Boardman Hospital
- Cleveland Clinic Mercy Hospital
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Geauga Hospital
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer Center
- Grady Memorial Hospital
- Dublin Methodist Hospital
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Central Ohio Breast and Endocrine Surgery
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Mount Carmel Grove City Hospital
- Cleveland Clinic Cancer Center Independence
- Greater Dayton Cancer Center
- Kettering Medical Center
- Fairfield Medical Center
- OhioHealth Mansfield Hospital
- Cleveland Clinic Cancer Center Mansfield
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- University Hospitals Parma Medical Center
- Southern Ohio Medical Center
- University Hospitals Portage Medical Center
- North Coast Cancer Care
- Trinity's Tony Teramana Cancer Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- Toledo Clinic Cancer Centers-Toledo
- Dayton Physicians LLC - Troy
- Upper Valley Medical Center
- University Hospitals Sharon Health Center
- South Pointe Hospital
- Saint Joseph Warren Hospital
- University of Cincinnati Cancer Center-West Chester
- Saint Ann's Hospital
- UH Seidman Cancer Center at Saint John Medical Center
- Cleveland Clinic Wooster Family Health and Surgery Center
- Saint Elizabeth Youngstown Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Three Rivers Community Hospital
- Legacy Mount Hood Medical Center
- Rogue Valley Medical Center
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Saint Charles Health System-Redmond
- Legacy Meridian Park Hospital
- Lehigh Valley Hospital-Cedar Crest
- UPMC Altoona
- UPMC-Heritage Valley Health System Beaver
- Lehigh Valley Hospital - Muhlenberg
- Crozer-Keystone Regional Cancer Center at Broomall
- Bryn Mawr Hospital
- UPMC Camp Hill
- Carlisle Regional Cancer Center
- Chambersburg Hospital
- Geisinger Medical Center
- Doylestown Hospital
- Delaware County Memorial Hospital
- Pocono Medical Center
- Ephrata Cancer Center
- UPMC Hillman Cancer Center Erie
- Saint Vincent Hospital
- UPMC Hamot
- UPMC Cancer Center at UPMC Horizon
- Adams Cancer Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Cherry Tree Cancer Center
- UPMC Pinnacle Harrisburg
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Geisinger Medical Center-Cancer Center Hazleton
- Lehigh Valley Hospital-Hazleton
- IRMC Cancer Center
- Jefferson Hospital
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Sechler Family Cancer Center
- Geisinger Medical Oncology-Lewisburg
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
- Riddle Memorial Hospital
- Forbes Hospital
- UPMC Hillman Cancer Center - Monroeville
- UPMC Hillman Cancer Center - Part of Frick Hospital
- Arnold Palmer Cancer Center Medical Oncology Norwin
- Allegheny Valley Hospital
- UPMC Hillman Cancer Center - New Castle
- Paoli Memorial Hospital
- Thomas Jefferson University Hospital
- Jefferson Torresdale Hospital
- Phoenixville Hospital
- Allegheny General Hospital
- Oncology Hematology Association
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Pottstown Hospital
- Geisinger Cancer Services-Pottsville
- Guthrie Medical Group PC-Robert Packer Hospital
- Community Medical Center
- UPMC Cancer Center at UPMC Northwest
- UPMC Cancer Center-Uniontown
- UPMC Cancer Center-Washington
- UPMC West Mifflin-Cancer Center Jefferson
- Reading Hospital
- Wexford Health and Wellness Pavilion
- Geisinger Wyoming Valley/Henry Cancer Center
- Asplundh Cancer Pavilion
- Lankenau Medical Center
- WellSpan Health-York Cancer Center
- Kent Hospital
- AnMed Health Cancer Center
- Saint Joseph's/Candler - Bluffton Campus
- Prisma Health Cancer Institute - Spartanburg
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Cancer Institute - Eastside
- Self Regional Healthcare
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- South Carolina Cancer Specialists PC
- Levine Cancer Institute-Rock Hill
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Avera Cancer Institute-Aberdeen
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Baptist Memorial Hospital and Cancer Center-Collierville
- Ballad Health Cancer Care - Kingsport
- Thompson Cancer Survival Center
- Thompson Cancer Survival Center - West
- Thompson Oncology Group-Lenoir City
- Thompson Oncology Group-Maryville
- Baptist Memorial Hospital and Cancer Center-Memphis
- Vanderbilt University/Ingram Cancer Center
- Thompson Oncology Group-Oak Ridge
- Hendrick Medical Center
- Saint Joseph Regional Cancer Center
- MD Anderson in The Woodlands
- UT Southwestern/Simmons Cancer Center-Dallas
- STCC at DHR Health Institute for Research and Development
- Lyndon Baines Johnson General Hospital
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Ben Taub General Hospital
- M D Anderson Cancer Center
- Michael E DeBakey VA Medical Center
- MD Anderson West Houston
- MD Anderson League City
- MD Anderson in Sugar Land
- Farmington Health Center
- University of Utah Sugarhouse Health Center
- Huntsman Cancer Institute/University of Utah
- Norris Cotton Cancer Center-North
- Wellmont Medical Associates-Bristol
- Kaiser Permanente-Burke Medical Center
- Sentara Martha Jefferson Hospital
- University of Virginia Cancer Center
- Cancer Specialists of Tidewater Limited
- Augusta Health Center for Cancer and Blood Disorders
- Peninsula Cancer Institute-Gloucester
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Kaiser Permanente Tysons Corner Medical Center
- Peninsula Cancer Institute-Newport News
- Riverside Shore Cancer Center
- Virginia Cancer Institute
- VCU Massey Cancer Center at Stony Point
- Virginia Commonwealth University/Massey Cancer Center
- Cancer Specialists of Tidewater-Suffolk
- Peninsula Cancer Institute-Cancer Specialists of Tidewater
- Peninsula Cancer Institute-Williamsburg
- Shenandoah Oncology PC
- Providence Regional Cancer System-Aberdeen
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Jefferson Healthcare
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Valley Medical Center
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- Franciscan Research Center-Northwest Medical Plaza
- PeaceHealth Southwest Medical Center
- Legacy Cancer Institute Medical Oncology and Day Treatment
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- West Virginia University Charleston Division
- Princeton Community Hospital
- Langlade Hospital and Cancer Center
- ThedaCare Regional Cancer Center
- Ascension Saint Elizabeth Hospital
- Ascension Southeast Wisconsin Hospital - Elmbrook Campus
- Aurora Cancer Care-Southern Lakes VLCC
- Ascension Calumet Hospital
- Marshfield Medical Center-EC Cancer Center
- Ascension Saint Francis - Reiman Cancer Center
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- University of Wisconsin Carbone Cancer Center
- Aurora Bay Area Medical Group-Marinette
- Marshfield Medical Center-Marshfield
- Aspirus Medford Hospital
- Froedtert Menomonee Falls Hospital
- Ascension Columbia Saint Mary's Hospital Ozaukee
- Aurora Cancer Care-Milwaukee
- Ascension Columbia Saint Mary's Hospital - Milwaukee
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Ascension Mercy Hospital
- Vince Lombardi Cancer Clinic - Oshkosh
- Ascension All Saints Hospital
- Aurora Cancer Care-Racine
- Marshfield Medical Center-Rice Lake
- ThedaCare Cancer Care - Shawano
- Saint Vincent Hospital Cancer Center at Sheboygan
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Marshfield Medical Center-River Region at Stevens Point
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- UW Cancer Center at ProHealth Care
- Aspirus Regional Cancer Center
- Ascension Medical Group Southeast Wisconsin - Mayfair Road
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Froedtert West Bend Hospital/Kraemer Cancer Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Welch Cancer Center
- Tom Baker Cancer Centre
- Cross Cancer Institute
- BCCA-Vancouver Cancer Centre
- CancerCare Manitoba
- Atlantic Health Sciences Corporation-Saint John Regional Hospital
- Royal Victoria Regional Health Centre
- Cambridge Memorial Hospital
- Juravinski Cancer Centre at Hamilton Health Sciences
- Kingston Health Sciences Centre
- London Regional Cancer Program
- Lakeridge Health Oshawa
- Ottawa Hospital and Cancer Center-General Campus
- Niagara Health System-Saint Catharines General
- North York General Hospital
- Mount Sinai Hospital
- CSSS Champlain-Charles Le Moyne
- Hopital de la Cite-de-la-Sante
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
- Jewish General Hospital
- Hopital Du Sacre-Coeur de Montreal
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Centro Comprensivo de Cancer de UPR
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (blood stored and tested for ctDNA later)
Arm II (blood tested for ctDNA at baseline)
Patients undergo active surveillance.
Patients are assigned to 1 of 2 groups. GROUP I (ctDNA DETECTED): At the discretion of the investigator, patients receive either oxaliplatin IV over 2 hours on day 1, leucovorin IV over 2 hours on day 1, and fluorouracil IV bolus over 2-4 minutes on day 1 and then by continuous IV over 46-48 hours repeated every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 1-14 repeated every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity at the discretion of the investigator. GROUP II (ctDNA NOT DETECTED): Patients undergo active surveillance.