Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation (JANUS)

September 5, 2025 updated by: Alliance for Clinical Trials in Oncology

The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate and compare the clinical complete response (cCR) rates in patients with locally advanced rectal cancer treated with neoadjuvant long-course neoadjuvant radiotherapy (LCRT) followed by neoadjuvant modified fluorouracil, irinotecan, leucovorin, and oxaliplatin (mFOLFIRINOX) versus neoadjuvant LCRT followed by neoadjuvant modified leucovorin , fluorouracil, and oxaliplatin (mFOLFOX6).

SECONDARY OBJECTIVES:

I. To evaluate and compare organ-preservation-time (OPT) between two treatment arms.

II. To evaluate and compare the disease-free survival (DFS) time between the two treatment arms.

III. To evaluate and compare time to distant metastasis between two treatment arms.

IV. To evaluate and compare overall survival (OS) between two treatment arms. V. To evaluate and compare toxicity profiles of total neoadjuvant therapy (TNT) between two treatment arms.

EXPLORATORY OBJECTIVE:

I. Evaluation of circulating tumor deoxyribonucleic acid (ctDNA) kinetics during neoadjuvant therapy & surveillance and to correlate with radiographic, pathologic, and clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

GROUP I: Patients receive long-course chemoradiation therapy on study and then receive either: FOLFOX regimen consisting of leucovorin intravenously (IV), fluorouracil IV, and oxaliplatin IV or CAPOX consisting of capecitabine orally (PO), and oxaliplatin IV on study. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), and biospecimen collection throughout the trial. Patients also undergo sigmoidoscopy throughout the trial and biopsy during screening.

GROUP II: Patients receive long-course chemoradiation therapy on study and then receive FOLFIRINOX regimen consisting of leucovorin IV, fluorouracil IV, irinotecan IV, and oxaliplatin IV on study. Patients undergo CT scan, MRI scan, and blood specimen collection throughout the trial. Patients undergo sigmoidoscopy throughout the trial and biopsy during screening.

Study Type

Interventional

Enrollment (Actual)

783

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Puerto Rico
- - Bayamón, Puerto Rico, 00959-5060
    - Cancer Center-Metro Medical Center Bayamon
  - Manatí, Puerto Rico, 00674
    - Doctors Cancer Center
  - San Juan, Puerto Rico, 00917
    - San Juan Community Oncology Group
  - San Juan, Puerto Rico, 00927
    - Centro Comprensivo de Cancer de UPR
  - San Juan, Puerto Rico, 00936
    - San Juan City Hospital
  - San Juan, Puerto Rico, 00902
    - Pan American Center for Oncology Trials LLC
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama at Birmingham Cancer Center
  - Mobile, Alabama, United States, 36688
    - University of South Alabama Mitchell Cancer Institute
- Alaska
  - Anchorage, Alaska, United States, 98508
    - Anchorage Associates in Radiation Medicine
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Oncology and Hematology LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
- Arizona
  - Kingman, Arizona, United States, 86401
    - Kingman Regional Medical Center
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Hospital in Arizona
  - Phoenix, Arizona, United States, 85004
    - Cancer Center at Saint Joseph's
- Arkansas
  - Fort Smith, Arkansas, United States, 72903
    - Mercy Hospital Fort Smith
  - Jonesboro, Arkansas, United States, 72401
    - NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
- California
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Arroyo Grande, California, United States, 93420
    - Mission Hope Medical Oncology - Arroyo Grande
  - Buena Park, California, United States, 90621
    - Keck Medicine of USC Buena Park
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Carmichael, California, United States, 95608
    - Mercy San Juan Medical Center
  - Carmichael, California, United States, 95608
    - Mercy Cancer Center - Carmichael
  - Duarte, California, United States, 91010
    - City of Hope Comprehensive Cancer Center
  - Elk Grove, California, United States, 95758
    - Mercy Cancer Center - Elk Grove
  - Fremont, California, United States, 94538
    - Washington Hospital
  - Irvine, California, United States, 92618
    - City of Hope at Irvine Lennar
  - Irvine, California, United States, 92612
    - UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - Los Angeles General Medical Center
  - Merced, California, United States, 95340
    - Mercy Cancer Center
  - Napa, California, United States, 94558
    - Providence Queen of The Valley
  - Newport Beach, California, United States, 92663
    - USC Norris Oncology/Hematology-Newport Beach
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Orange, California, United States, 92868
    - Saint Joseph Hospital - Orange
  - Rocklin, California, United States, 95765
    - Mercy Cancer Center - Rocklin
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - Sacramento, California, United States, 95816
    - Mercy Cancer Center - Sacramento
  - Salinas, California, United States, 93901
    - Salinas Valley Memorial
  - San Luis Obispo, California, United States, 93401
    - Pacific Central Coast Health Center-San Luis Obispo
  - Santa Maria, California, United States, 93444
    - Mission Hope Medical Oncology - Santa Maria
  - Santa Rosa, California, United States, 95403
    - Providence Medical Foundation - Santa Rosa
  - South Pasadena, California, United States, 91030
    - City of Hope South Pasadena
  - St. Helena, California, United States, 94574
    - Saint Helena Hospital
  - Stockton, California, United States, 95204
    - Saint Joseph's Medical Center
  - Torrance, California, United States, 90503
    - City of Hope South Bay
  - Truckee, California, United States, 96161
    - Gene Upshaw Memorial Tahoe Forest Cancer Center
  - Upland, California, United States, 91786
    - City of Hope Upland
  - Walnut Creek, California, United States, 94598
    - John Muir Medical Center-Walnut Creek
  - Woodland, California, United States, 95695
    - Woodland Memorial Hospital
- Colorado
  - Aurora, Colorado, United States, 80045
    - UCHealth University of Colorado Hospital
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80909
    - UCHealth Memorial Hospital Central
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Colorado Springs, Colorado, United States, 80920
    - Memorial Hospital North
  - Colorado Springs, Colorado, United States, 80923
    - Saint Francis Cancer Center
  - Denver, Colorado, United States, 80206
    - UCHealth - Cherry Creek
  - Denver, Colorado, United States, 80218
    - Saint Joseph Hospital - Cancer Centers of Colorado
  - Denver, Colorado, United States, 80210
    - AdventHealth Porter
  - Golden, Colorado, United States, 80401
    - Lutheran Hospital - Cancer Centers of Colorado
  - Grand Junction, Colorado, United States, 81501
    - Saint Mary's Hospital and Regional Medical Center
  - Highlands Ranch, Colorado, United States, 80129
    - UCHealth Highlands Ranch Hospital
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Littleton, Colorado, United States, 80122
    - AdventHealth Littleton
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Parker, Colorado, United States, 80138
    - AdventHealth Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Westminster, Colorado, United States, 80023
    - Saint Anthony North Hospital
  - Wheat Ridge, Colorado, United States, 80401
    - Intermountain Health Lutheran Hospital
- Connecticut
  - Hartford, Connecticut, United States, 06102
    - Hartford Hospital
  - Meriden, Connecticut, United States, 06451
    - Midstate Medical Center
  - New Britain, Connecticut, United States, 06050
    - The Hospital of Central Connecticut
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Millville, Delaware, United States, 19967
    - Beebe South Coastal Health Campus
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20037
    - George Washington University Medical Center
  - Washington D.C., District of Columbia, United States, 20010
    - MedStar Washington Hospital Center
  - Washington D.C., District of Columbia, United States, 20007
    - MedStar Georgetown University Hospital
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - AdventHealth Altamonte
  - Aventura, Florida, United States, 33180
    - Mount Sinai Comprehensive Cancer Center at Aventura
  - Celebration, Florida, United States, 34747
    - AdventHealth Celebration
  - Clearwater, Florida, United States, 33756
    - Morton Plant Hospital
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Gainesville, Florida, United States, 32610
    - University of Florida Health Science Center - Gainesville
  - Hollywood, Florida, United States, 33021
    - Memorial Regional Hospital/Joe DiMaggio Children's Hospital
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
  - Kissimmee, Florida, United States, 34744
    - AdventHealth Kissimmee
  - Lutz, Florida, United States, 33558
    - Saint Joseph's Hospital-North
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32803
    - AdventHealth Orlando
  - Orlando, Florida, United States, 32822
    - AdventHealth East Orlando
  - Pembroke Pines, Florida, United States, 33028
    - Memorial Hospital West
  - St. Petersburg, Florida, United States, 33705
    - Saint Anthony's Hospital Cancer Care Center
  - Tampa, Florida, United States, 33606
    - Tampa General Hospital
  - Tampa, Florida, United States, 33607
    - Saint Joseph's Hospital/Children's Hospital-Tampa
- Georgia
  - Atlanta, Georgia, United States, 30308
    - Emory University Hospital Midtown
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital/Winship Cancer Institute
  - Atlanta, Georgia, United States, 30342
    - Emory Saint Joseph's Hospital
  - Decatur, Georgia, United States, 30033
    - Emory Decatur Hospital
  - Johns Creek, Georgia, United States, 30097
    - Emory Johns Creek Hospital
  - Savannah, Georgia, United States, 31404
    - Memorial Health University Medical Center
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Cenrer - POB I
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Kuakini Medical Center
  - Honolulu, Hawaii, United States, 96817
    - Queen's Cancer Center - Kuakini
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
  - ‘Aiea, Hawaii, United States, 96701
    - Hawaii Cancer Care - Westridge
  - ‘Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - ‘Aiea, Hawaii, United States, 96701
    - Queen's Cancer Center - Pearlridge
  - ‘Aiea, Hawaii, United States, 96701
    - The Cancer Center of Hawaii-Pali Momi
  - ‘Ewa Beach, Hawaii, United States, 96706
    - The Queen's Medical Center - West Oahu
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, United States, 83712
    - Saint Luke's Cancer Institute - Boise
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Health - Coeur d'Alene
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meridian
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, United States, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Nampa, Idaho, United States, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Alton, Illinois, United States, 62002
    - OSF Saint Anthony's Health Center
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Medical Center
  - Aurora, Illinois, United States, 60506
    - Advocate Outpatient Center - Aurora
  - Barrington, Illinois, United States, 60010
    - Advocate Good Shepherd Hospital
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Bloomington, Illinois, United States, 61701
    - OSF Saint Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Carterville, Illinois, United States, 62918
    - SIH Cancer Institute
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Centralia, Illinois, United States, 62801
    - Saint Mary's Hospital
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60637
    - University of Chicago Comprehensive Cancer Center
  - Chicago, Illinois, United States, 60612
    - John H Stroger Jr Hospital of Cook County
  - Chicago, Illinois, United States, 60657
    - Advocate Illinois Masonic Medical Center
  - Crystal Lake, Illinois, United States, 60014
    - AMG Crystal Lake - Oncology
  - Danville, Illinois, United States, 61832
    - Carle at The Riverfront
  - DeKalb, Illinois, United States, 60115
    - Northwestern Medicine Cancer Center Kishwaukee
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, United States, 61021
    - Illinois CancerCare-Dixon
  - Downers Grove, Illinois, United States, 60515
    - Advocate Good Samaritan Hospital
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Elgin, Illinois, United States, 60123
    - Advocate Sherman Hospital
  - Elmhurst, Illinois, United States, 60126
    - Elmhurst Memorial Hospital
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Geneva, Illinois, United States, 60134
    - Northwestern Medicine Cancer Center Delnor
  - Glenview, Illinois, United States, 60026
    - Northwestern Medicine Glenview Outpatient Center
  - Grayslake, Illinois, United States, 60030
    - Northwestern Medicine Grayslake Outpatient Center
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Hazel Crest, Illinois, United States, 60429
    - Advocate South Suburban Hospital
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Lake Forest, Illinois, United States, 60045
    - Northwestern Medicine Lake Forest Hospital
  - Libertyville, Illinois, United States, 60048
    - Condell Memorial Hospital
  - Libertyville, Illinois, United States, 60048
    - AMG Libertyville - Oncology
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Mount Vernon, Illinois, United States, 62864
    - SSM Health Good Samaritan
  - Naperville, Illinois, United States, 60540
    - Edward Hospital/Cancer Center
  - New Lenox, Illinois, United States, 60451
    - UC Comprehensive Cancer Center at Silver Cross
  - Normal, Illinois, United States, 61761
    - Carle Cancer Institute Normal
  - Normal, Illinois, United States, 61761
    - Carle BroMenn Medical Center
  - O'Fallon, Illinois, United States, 62269
    - Cancer Care Center of O'Fallon
  - O'Fallon, Illinois, United States, 62269
    - HSHS Saint Elizabeth's Hospital
  - Oak Lawn, Illinois, United States, 60453-2699
    - Advocate Christ Medical Center
  - Orland Park, Illinois, United States, 60462
    - University of Chicago Medicine-Orland Park
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Palos Heights, Illinois, United States, 60463
    - Advocate High Tech Medical Park
  - Park Ridge, Illinois, United States, 60068
    - Advocate Lutheran General Hospital
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Valley Radiation Oncology
  - Plainfield, Illinois, United States, 60585
    - Edward Hospital/Cancer Center?Plainfield
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Springfield, Illinois, United States, 62781
    - Springfield Memorial Hospital
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Warrenville, Illinois, United States, 60555
    - Northwestern Medicine Cancer Center Warrenville
  - Washington, Illinois, United States, 61571
    - Illinois CancerCare - Washington
- Indiana
  - Crown Point, Indiana, United States, 46307
    - Northwest Cancer Center - Main Campus
  - Dyer, Indiana, United States, 46311
    - Northwest Oncology LLC
  - Fort Wayne, Indiana, United States, 46845
    - Parkview Regional Medical Center
  - Hobart, Indiana, United States, 46342
    - Northwest Cancer Center - Hobart
  - Hobart, Indiana, United States, 46342
    - Saint Mary Medical Center
  - Munster, Indiana, United States, 46321
    - The Community Hospital
  - Munster, Indiana, United States, 46321
    - Women's Diagnostic Center - Munster
  - New Albany, Indiana, United States, 47150
    - Baptist Health Floyd
  - Richmond, Indiana, United States, 47374
    - Reid Health
  - Valparaiso, Indiana, United States, 46383
    - Northwest Cancer Center - Valparaiso
- Iowa
  - Ankeny, Iowa, United States, 50023
    - UI Health Care Mission Cancer and Blood - Ankeny Clinic
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, United States, 50325
    - UI Health Care Mission Cancer and Blood - West Des Moines Clinic
  - Creston, Iowa, United States, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - UI Health Care Mission Cancer and Blood - Des Moines Clinic
  - Des Moines, Iowa, United States, 50314
    - UI Health Care Mission Cancer and Blood - Laurel Clinic
  - Waukee, Iowa, United States, 50263
    - UI Health Care Mission Cancer and Blood - Waukee Clinic
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Garden City, Kansas, United States, 67846
    - Central Care Cancer Center - Garden City
  - Great Bend, Kansas, United States, 67530
    - Central Care Cancer Center - Great Bend
- Kentucky
  - Corbin, Kentucky, United States, 40701
    - Baptist Health Corbin
  - Edgewood, Kentucky, United States, 41017
    - Saint Elizabeth Healthcare Edgewood
  - Fort Thomas, Kentucky, United States, 41075
    - Saint Elizabeth Healthcare Fort Thomas
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Lexington, Kentucky, United States, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, United States, 40509
    - Saint Joseph Hospital East
  - Lexington, Kentucky, United States, 40503
    - Baptist Health Lexington
  - Lexington, Kentucky, United States, 40504
    - Saint Joseph Hospital
  - Lexington, Kentucky, United States, 40509
    - Baptist Health Hamburg
  - Louisville, Kentucky, United States, 40202
    - The James Graham Brown Cancer Center at University of Louisville
  - Louisville, Kentucky, United States, 40245
    - UofL Health Medical Center Northeast
  - Louisville, Kentucky, United States, 40207
    - Baptist Health Louisville
  - Paducah, Kentucky, United States, 42003
    - Baptist Health Paducah
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Ochsner Hematology Oncology North Shore - Covington (West Region)
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, United States, 70112
    - University Medical Center New Orleans
- Maine
  - Brewer, Maine, United States, 04412
    - Lafayette Family Cancer Center-EMMC
- Maryland
  - Baltimore, Maryland, United States, 21237
    - MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  - Baltimore, Maryland, United States, 21215
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, United States, 21239
    - MedStar Good Samaritan Hospital
  - Cumberland, Maryland, United States, 21502
    - UPMC Western Maryland
  - Westminster, Maryland, United States, 21157
    - William E Kahlert Regional Cancer Center/Sinai Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Burlington, Massachusetts, United States, 01805
    - Lahey Hospital and Medical Center
  - Foxborough, Massachusetts, United States, 02035
    - Dana-Farber Cancer Institute at Foxborough
  - Methuen, Massachusetts, United States, 01844
    - Dana Farber-Merrimack Valley
  - Milford, Massachusetts, United States, 01757
    - Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
  - Peabody, Massachusetts, United States, 01960
    - Lahey Medical Center-Peabody
  - South Weymouth, Massachusetts, United States, 02190
    - Dana-Farber/Brigham and Women's Cancer Center at South Shore
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Trinity Health Saint Joseph Mercy Hospital Ann Arbor
  - Brighton, Michigan, United States, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Brighton, Michigan, United States, 48116
    - University of Michigan - Brighton Center for Specialty Care
  - Brighton, Michigan, United States, 48114
    - Trinity Health Medical Center - Brighton
  - Brownstown, Michigan, United States, 48183
    - Henry Ford Cancer Institute-Downriver
  - Canton, Michigan, United States, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Canton, Michigan, United States, 48188
    - Trinity Health Medical Center - Canton
  - Caro, Michigan, United States, 48723
    - Caro Cancer Center
  - Chelsea, Michigan, United States, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Chelsea, Michigan, United States, 48118
    - Chelsea Hospital
  - Clinton Township, Michigan, United States, 48038
    - Henry Ford Macomb Hospital-Clinton Township
  - Dearborn, Michigan, United States, 48124
    - Corewell Health Dearborn Hospital
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48236
    - Henry Ford Health Saint John Hospital
  - Farmington Hills, Michigan, United States, 48336
    - Corewell Health Farmington Hills Hospital
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Henry Ford Saint John Hospital - Van Elslander
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Lansing, Michigan, United States, 48912
    - University of Michigan Health - Sparrow Lansing
  - Livonia, Michigan, United States, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Macomb, Michigan, United States, 48044
    - Henry Ford Saint John Hospital - Macomb Medical
  - Marlette, Michigan, United States, 48453
    - Saint Mary's Oncology/Hematology Associates of Marlette
  - Midland, Michigan, United States, 48670
    - MyMichigan Medical Center Midland
  - Novi, Michigan, United States, 48377
    - Henry Ford Medical Center-Columbus
  - Novi, Michigan, United States, 48374
    - Henry Ford Health Providence Novi Hospital
  - Pontiac, Michigan, United States, 48341
    - Trinity Health Saint Joseph Mercy Oakland Hospital
  - Pontiac, Michigan, United States, 48341
    - Michigan Healthcare Professionals Pontiac
  - Royal Oak, Michigan, United States, 48073
    - Corewell Health William Beaumont University Hospital
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saginaw, Michigan, United States, 48601
    - MyMichigan Medical Center Saginaw
  - Southfield, Michigan, United States, 48075
    - Henry Ford Health Providence Southfield Hospital
  - Tawas City, Michigan, United States, 48764
    - MyMichigan Medical Center Tawas
  - Troy, Michigan, United States, 48085
    - Corewell Health Beaumont Troy Hospital
  - Warren, Michigan, United States, 48093
    - Henry Ford Health Warren Hospital
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford West Bloomfield Hospital
  - West Branch, Michigan, United States, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Ypsilanti, Michigan, United States, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Brainerd, Minnesota, United States, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Burnsville, Minnesota, United States, 55337
    - Minnesota Oncology - Burnsville
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Deer River, Minnesota, United States, 56636
    - Essentia Health - Deer River Clinic
  - Detroit Lakes, Minnesota, United States, 56501
    - Essentia Health Saint Mary's - Detroit Lakes Clinic
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fosston, Minnesota, United States, 56542
    - Essentia Health - Fosston
  - Hibbing, Minnesota, United States, 55746
    - Essentia Health Hibbing Clinic
  - Maple Grove, Minnesota, United States, 55369
    - Fairview Clinics and Surgery Center Maple Grove
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - Monticello, Minnesota, United States, 55362
    - Monticello Cancer Center
  - Park Rapids, Minnesota, United States, 56470
    - Essentia Health - Park Rapids
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center at Saint Cloud Hospital
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Sandstone, Minnesota, United States, 55072
    - Essentia Health Sandstone
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Virginia, Minnesota, United States, 55792
    - Essentia Health Virginia Clinic
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
- Mississippi
  - Columbus, Mississippi, United States, 39705
    - Baptist Memorial Hospital and Cancer Center-Golden Triangle
  - Grenada, Mississippi, United States, 38901
    - Baptist Cancer Center-Grenada
  - New Albany, Mississippi, United States, 38652
    - Baptist Memorial Hospital and Cancer Center-Union County
  - Oxford, Mississippi, United States, 38655
    - Baptist Memorial Hospital and Cancer Center-Oxford
  - Southhaven, Mississippi, United States, 38671
    - Baptist Memorial Hospital and Cancer Center-Desoto
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center - Bolivar
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Mercy Cancer Center - Cape Girardeau
  - Farmington, Missouri, United States, 63640
    - Parkland Health Center - Farmington
  - Jefferson City, Missouri, United States, 65109
    - MU Health Care Goldschmidt Cancer Center
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Osage Beach, Missouri, United States, 65065
    - Lake Regional Hospital
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Rolla, Missouri, United States, 65401
    - Phelps Health Delbert Day Cancer Institute
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Sainte Genevieve, Missouri, United States, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - St Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - St Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - St Louis, Missouri, United States, 63128
    - Mercy Hospital South
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - BJC Outpatient Center at Sunset Hills
- Montana
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Health Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Sletten Cancer Institute
  - Havre, Montana, United States, 59501
    - Hi-Line Sletten Cancer Center
  - Kalispell, Montana, United States, 59901
    - Logan Health Medical Center
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59804
    - Community Medical Center
- Nebraska
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
- Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - OptumCare Cancer Care at Seven Hills
  - Las Vegas, Nevada, United States, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, United States, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89109
    - GenesisCare USA - Las Vegas
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, United States, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada - Town Center
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - OptumCare Cancer Care at Fort Apache
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89148
    - GenesisCare USA - Fort Apache
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, United States, 89509
    - Radiation Oncology Associates
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology Hematology PA-Concord
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  - Londonderry, New Hampshire, United States, 03053
    - The Dana-Farber Cancer Institute at Londonderry
  - Manchester, New Hampshire, United States, 03103
    - Solinsky Center for Cancer Care
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering Basking Ridge
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - Cherry Hill, New Jersey, United States, 08002
    - Jefferson Cherry Hill Hospital
  - Middletown, New Jersey, United States, 07748
    - Memorial Sloan Kettering Monmouth
  - Montvale, New Jersey, United States, 07645
    - Memorial Sloan Kettering Bergen
  - Morristown, New Jersey, United States, 07960
    - Morristown Medical Center
  - Paramus, New Jersey, United States, 07652
    - The Valley Hospital - Luckow Pavilion
  - Pompton, New Jersey, United States, 07444
    - Chilton Medical Center
  - Ridgewood, New Jersey, United States, 07450
    - Valley Health System Ridgewood Campus
  - Sewell, New Jersey, United States, 08080
    - Sidney Kimmel Cancer Center Washington Township
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
  - Teaneck, New Jersey, United States, 07666
    - Holy Name Hospital
  - Westwood, New Jersey, United States, 07675
    - Valley Health System-Hematology/Oncology
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - University of New Mexico Cancer Center
- New York
  - Brooklyn, New York, United States, 11215
    - New York-Presbyterian/Brooklyn Methodist Hospital
  - Brooklyn, New York, United States, 11220
    - NYU Langone Hospital - Brooklyn
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Commack, New York, United States, 11725
    - Memorial Sloan Kettering Commack
  - Flushing, New York, United States, 11355
    - The New York Hospital Medical Center of Queens
  - Forest Hills, New York, United States, 11375
    - Northwell Health Physicians Partners Radiation Medicine at Queens
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - Greenlawn, New York, United States, 11740
    - Northwell Health Cancer Institute at Huntington
  - Harrison, New York, United States, 10604
    - Memorial Sloan Kettering Westchester
  - Lake Success, New York, United States, 11042
    - Northwell Health/Center for Advanced Medicine
  - Manhasset, New York, United States, 11030
    - North Shore University Hospital
  - Middletown, New York, United States, 10940
    - Garnet Health Medical Center
  - Mineola, New York, United States, 11501
    - NYU Langone Hospital - Long Island
  - Mount Kisco, New York, United States, 10549
    - Northern Westchester Hospital
  - New Hyde Park, New York, United States, 11040
    - Long Island Jewish Medical Center
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10019
    - Mount Sinai West
  - New York, New York, United States, 10029
    - Mount Sinai Hospital
  - New York, New York, United States, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  - New York, New York, United States, 10065
    - NYP/Weill Cornell Medical Center
  - New York, New York, United States, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - New York, New York, United States, 10075
    - Lenox Hill Hospital
  - New York, New York, United States, 10065
    - Manhattan Eye Ear and Throat Hospital
  - Oswego, New York, United States, 13126
    - Upstate Cancer Center at Oswego
  - Rego Park, New York, United States, 11374
    - Queens Cancer Center
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Sleepy Hollow, New York, United States, 10591
    - Phelps Memorial Hospital Center
  - Syracuse, New York, United States, 13210
    - State University of New York Upstate Medical University
  - Syracuse, New York, United States, 13215
    - SUNY Upstate Medical Center-Community Campus
  - The Bronx, New York, United States, 10461
    - Montefiore Medical Center-Einstein Campus
  - The Bronx, New York, United States, 10467
    - Montefiore Medical Center - Moses Campus
  - The Bronx, New York, United States, 10461
    - Montefiore Medical Center-Weiler Hospital
  - Uniondale, New York, United States, 11553
    - Memorial Sloan Kettering Nassau
  - Verona, New York, United States, 13478
    - Upstate Cancer Center at Verona
  - Webster, New York, United States, 14580
    - Wilmot Cancer Institute at Webster
- North Carolina
  - Albemarle, North Carolina, United States, 28002
    - Atrium Health Stanly/LCI-Albemarle
  - Cary, North Carolina, United States, 27518
    - Duke Cancer Center Cary
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Charlotte, North Carolina, United States, 28203
    - Carolinas Medical Center/Levine Cancer Institute
  - Charlotte, North Carolina, United States, 28210
    - Atrium Health Pineville/LCI-Pineville
  - Charlotte, North Carolina, United States, 28262
    - Atrium Health University City/LCI-University
  - Charlotte, North Carolina, United States, 28211
    - Levine Cancer Institute-SouthPark
  - Charlotte, North Carolina, United States, 28277
    - Levine Cancer Institute-Ballantyne
  - Clemmons, North Carolina, United States, 27012
    - Wake Forest University at Clemmons
  - Concord, North Carolina, United States, 28025
    - Atrium Health Cabarrus/LCI-Concord
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Forest City, North Carolina, United States, 28043
    - Levine Cancer Institute - Rutherford
  - Gastonia, North Carolina, United States, 28054
    - Levine Cancer Institute-Gaston
  - Greenville, North Carolina, United States, 27834
    - East Carolina University
  - High Point, North Carolina, United States, 27262
    - Hayworth Cancer Center
  - Hillsborough, North Carolina, United States, 27278
    - University of North Carolina-Hillsborough Campus
  - Lincolnton, North Carolina, United States, 28092
    - Atrium Health Lincoln/LCI-Lincolnton
  - Matthews, North Carolina, United States, 28104
    - Levine Cancer Institute - Union West
  - Monroe, North Carolina, United States, 28112
    - Atrium Health Union/LCI-Union
  - Raleigh, North Carolina, United States, 27609
    - Duke Cancer Center Raleigh
  - Shelby, North Carolina, United States, 28150
    - Atrium Health Cleveland/LCI-Cleveland
  - Wilkesboro, North Carolina, United States, 28659
    - Wake Forest Baptist Health - Wilkes Medical Center
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Jamestown, North Dakota, United States, 58401
    - Essentia Health - Jamestown Clinic
- Ohio
  - Beavercreek, Ohio, United States, 45431
    - Indu and Raj Soin Medical Center
  - Boardman, Ohio, United States, 44512
    - Saint Elizabeth Boardman Hospital
  - Canton, Ohio, United States, 44710
    - Aultman Health Foundation
  - Centerville, Ohio, United States, 45459
    - Dayton Physicians LLC-Miami Valley South
  - Cincinnati, Ohio, United States, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Dayton, Ohio, United States, 45415
    - Dayton Physician LLC - Englewood
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Findlay, Ohio, United States, 45840
    - Armes Family Cancer Center
  - Findlay, Ohio, United States, 45840
    - Orion Cancer Care
  - Franklin, Ohio, United States, 45005
    - Dayton Physicians LLC-Atrium
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Greenville, Ohio, United States, 45331
    - Dayton Physicians LLC-Wayne
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Kettering, Ohio, United States, 45409
    - Greater Dayton Cancer Center
  - Troy, Ohio, United States, 45373
    - Dayton Physicians LLC - Troy
  - Warren, Ohio, United States, 44484
    - Saint Joseph Warren Hospital
  - Youngstown, Ohio, United States, 44501
    - Saint Elizabeth Youngstown Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
- Oregon
  - Bend, Oregon, United States, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, United States, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital and Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Altoona, Pennsylvania, United States, 16601
    - UPMC Altoona
  - Beaver, Pennsylvania, United States, 15009
    - UPMC-Heritage Valley Health System Beaver
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Camp Hill, Pennsylvania, United States, 17011
    - UPMC Camp Hill
  - Carlisle, Pennsylvania, United States, 17015
    - Carlisle Regional Cancer Center
  - Chadds Ford, Pennsylvania, United States, 19317
    - Christiana Care Health System-Concord Health Center
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Pocono Medical Center
  - Erie, Pennsylvania, United States, 16505
    - UPMC Hillman Cancer Center Erie
  - Erie, Pennsylvania, United States, 16544
    - Saint Vincent Hospital
  - Farrell, Pennsylvania, United States, 16121
    - UPMC Cancer Center at UPMC Horizon
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Greenville, Pennsylvania, United States, 16125
    - UPMC Hillman Cancer Center in Greenville/UPMC Horizon
  - Harrisburg, Pennsylvania, United States, 17109
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - Indiana, Pennsylvania, United States, 15701
    - IRMC Cancer Center
  - Jefferson Hills, Pennsylvania, United States, 15025
    - Jefferson Hospital
  - Johnstown, Pennsylvania, United States, 15901
    - UPMC-Johnstown/John P. Murtha Regional Cancer Center
  - McKeesport, Pennsylvania, United States, 15132
    - UPMC Cancer Center at UPMC McKeesport
  - Mechanicsburg, Pennsylvania, United States, 17050
    - UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
  - Monroeville, Pennsylvania, United States, 15146
    - Forbes Hospital
  - Monroeville, Pennsylvania, United States, 15146
    - UPMC Hillman Cancer Center - Monroeville
  - Monroeville, Pennsylvania, United States, 15146
    - UPMC Cancer Center - Monroeville
  - Moon Township, Pennsylvania, United States, 15108
    - UPMC Hillman Cancer Center in Coraopolis
  - Mount Pleasant, Pennsylvania, United States, 15666
    - UPMC Hillman Cancer Center - Part of Frick Hospital
  - N. Huntingdon, Pennsylvania, United States, 15642
    - Arnold Palmer Cancer Center Medical Oncology Norwin
  - Natrona Heights, Pennsylvania, United States, 15065
    - UPMC Cancer Center-Natrona Heights
  - New Castle, Pennsylvania, United States, 16105
    - UPMC Hillman Cancer Center - New Castle
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University Hospital
  - Philadelphia, Pennsylvania, United States, 19114
    - Jefferson Torresdale Hospital
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15224
    - West Penn Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC-Magee Womens Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - Pittsburgh, Pennsylvania, United States, 15232
    - UPMC-Shadyside Hospital
  - Pittsburgh, Pennsylvania, United States, 15215
    - UPMC-Saint Margaret
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC-Passavant Hospital
  - Pittsburgh, Pennsylvania, United States, 15243
    - UPMC-Saint Clair Hospital Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15219
    - UPMC-Mercy Hospital
  - Seneca, Pennsylvania, United States, 16346
    - UPMC Cancer Center at UPMC Northwest
  - Uniontown, Pennsylvania, United States, 15401
    - UPMC Uniontown Hospital Radiation Oncology
  - Uniontown, Pennsylvania, United States, 15401
    - UPMC Cancer Center-Uniontown
  - Washington, Pennsylvania, United States, 15301
    - UPMC Washington Hospital Radiation Oncology
  - Washington, Pennsylvania, United States, 15301
    - UPMC Cancer Center-Washington
  - West Chester, Pennsylvania, United States, 19380
    - Chester County Hospital
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wexford, Pennsylvania, United States, 15090
    - Wexford Health and Wellness Pavilion
  - Williamsport, Pennsylvania, United States, 17754
    - Divine Providence Hospital
  - Willow Grove, Pennsylvania, United States, 19090
    - Asplundh Cancer Pavilion
  - York, Pennsylvania, United States, 17408
    - UPMC Memorial
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Gaffney, South Carolina, United States, 29341
    - Gibbs Cancer Center-Gaffney
  - Georgetown, South Carolina, United States, 29440
    - Tidelands Georgetown Memorial Hospital
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Greer, South Carolina, United States, 29651
    - Gibbs Cancer Center-Pelham
  - Murrells Inlet, South Carolina, United States, 29576
    - MUSC Health Tidelands Health Radiation Therapy Center
  - Rock Hill, South Carolina, United States, 29732
    - Levine Cancer Institute-Rock Hill
  - Rock Hill, South Carolina, United States, 29730
    - Rock Hill Radiation Therapy Center
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Center
  - Union, South Carolina, United States, 29379
    - SMC Center for Hematology Oncology Union
  - West Columbia, South Carolina, United States, 29169
    - Lexington Medical Center
- South Dakota
  - Aberdeen, South Dakota, United States, 57401
    - Avera Cancer Institute-Aberdeen
  - Mitchell, South Dakota, United States, 57301
    - Avera Cancer Institute - Mitchell
  - Pierre, South Dakota, United States, 57501
    - Avera Cancer Institute at Pierre
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
  - Yankton, South Dakota, United States, 57078
    - Avera Cancer Institute at Yankton
- Tennessee
  - Collierville, Tennessee, United States, 38017
    - Baptist Memorial Hospital and Cancer Center-Collierville
  - Germantown, Tennessee, United States, 38138
    - The West Clinic - Wolf River
  - Memphis, Tennessee, United States, 38120
    - Baptist Memorial Hospital and Cancer Center-Memphis
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University/Ingram Cancer Center
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt Breast Center at One Hundred Oaks
- Texas
  - Amarillo, Texas, United States, 79106
    - The Don and Sybil Harrington Cancer Center
  - Conroe, Texas, United States, 77384
    - MD Anderson in The Woodlands
  - Dallas, Texas, United States, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Dallas, Texas, United States, 75237
    - UT Southwestern Simmons Cancer Center - RedBird
  - Fort Worth, Texas, United States, 76104
    - UT Southwestern/Simmons Cancer Center-Fort Worth
  - Fort Worth, Texas, United States, 76104
    - Tarrant County Hospital District/JPS Health Network
  - Houston, Texas, United States, 77030
    - M D Anderson Cancer Center
  - Houston, Texas, United States, 77026-1967
    - Lyndon Baines Johnson General Hospital
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  - Houston, Texas, United States, 77030
    - Ben Taub General Hospital
  - Houston, Texas, United States, 77079
    - MD Anderson West Houston
  - League City, Texas, United States, 77573
    - MD Anderson League City
  - Richardson, Texas, United States, 75080
    - UT Southwestern Clinical Center at Richardson/Plano
  - Round Rock, Texas, United States, 78665
    - Scott and White Healthcare Round Rock
  - San Antonio, Texas, United States, 78229
    - University of Texas Health Science Center at San Antonio
  - Sugar Land, Texas, United States, 77478
    - MD Anderson in Sugar Land
  - Temple, Texas, United States, 76508
    - Scott and White Memorial Hospital
- Utah
  - Farmington, Utah, United States, 84025
    - Farmington Health Center
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
  - Salt Lake City, Utah, United States, 84106
    - University of Utah Sugarhouse Health Center
- Vermont
  - Berlin Corners, Vermont, United States, 05602
    - Central Vermont Medical Center/National Life Cancer Treatment
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center
  - Burlington, Vermont, United States, 05405
    - University of Vermont and State Agricultural College
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Cancer Center
  - Fairfax, Virginia, United States, 22031
    - Inova Schar Cancer Institute
  - Fairfax, Virginia, United States, 22033
    - Inova Fair Oaks Hospital
  - Falls Church, Virginia, United States, 22042
    - Inova Fairfax Hospital
  - Leesburg, Virginia, United States, 20176
    - Inova Loudoun Hospital
  - Martinsville, Virginia, United States, 24112
    - Sovah Health Martinsville
  - Richmond, Virginia, United States, 23235
    - VCU Massey Cancer Center at Stony Point
  - Richmond, Virginia, United States, 23229
    - Virginia Cancer Institute
  - Richmond, Virginia, United States, 23298
    - VCU Massey Comprehensive Cancer Center
- Washington
  - Aberdeen, Washington, United States, 98520
    - Providence Regional Cancer System-Aberdeen
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, United States, 98026
    - Swedish Cancer Institute-Edmonds
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Kirkland, Washington, United States, 98034
    - FHCC at EvergreenHealth
  - Lacey, Washington, United States, 98503
    - Providence Regional Cancer System-Lacey
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Mount Vernon, Washington, United States, 98274
    - Skagit Regional Health Cancer Care Center
  - Renton, Washington, United States, 98055
    - Valley Medical Center
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center - Montlake
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Center
  - Sedro-Woolley, Washington, United States, 98284
    - PeaceHealth United General Medical Center
  - Silverdale, Washington, United States, 98383
    - Saint Michael Cancer Center
  - Vancouver, Washington, United States, 98686
    - Legacy Salmon Creek Hospital
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Vancouver, Washington, United States, 98684
    - Legacy Cancer Institute Medical Oncology and Day Treatment
  - Walla Walla, Washington, United States, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yakima, Washington, United States, 98902
    - North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia
  - Bridgeport, West Virginia, United States, 26330
    - United Hospital Center
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Healthcare
  - Parkersburg, West Virginia, United States, 26101
    - Camden Clark Medical Center
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Langlade Hospital and Cancer Center
  - Ashland, Wisconsin, United States, 54806
    - Duluth Clinic Ashland
  - Ashland, Wisconsin, United States, 54806
    - Northwest Wisconsin Cancer Center
  - Burlington, Wisconsin, United States, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Medical Center-EC Cancer Center
  - Germantown, Wisconsin, United States, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Hayward, Wisconsin, United States, 54843
    - Essentia Health-Hayward Clinic
  - Kenosha, Wisconsin, United States, 53142
    - Aurora Cancer Care-Kenosha South
  - Marinette, Wisconsin, United States, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Medford, Wisconsin, United States, 54451
    - Aspirus Medford Hospital
  - Menomonee Falls, Wisconsin, United States, 53051
    - Froedtert Menomonee Falls Hospital
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Medical Center - Minocqua
  - Mukwonago, Wisconsin, United States, 53149
    - ProHealth D N Greenwald Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oak Creek, Wisconsin, United States, 53154
    - Drexel Town Square Health Center
  - Oconomowoc, Wisconsin, United States, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Racine, Wisconsin, United States, 53406
    - Aurora Cancer Care-Racine
  - Rhinelander, Wisconsin, United States, 54501
    - Aspirus Cancer Care - James Beck Cancer Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Sheboygan, Wisconsin, United States, 53081
    - Saint Vincent Hospital Cancer Center at Sheboygan
  - Spooner, Wisconsin, United States, 54801
    - Essentia Health-Spooner Clinic
  - Stevens Point, Wisconsin, United States, 54482
    - Marshfield Medical Center-River Region at Stevens Point
  - Stevens Point, Wisconsin, United States, 54481
    - Aspirus Cancer Care - Stevens Point
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Superior, Wisconsin, United States, 54880
    - Essentia Health Saint Mary's Hospital - Superior
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Waukesha, Wisconsin, United States, 53188
    - UW Cancer Center at ProHealth Care
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Regional Cancer Center
  - Wauwatosa, Wisconsin, United States, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center
  - West Bend, Wisconsin, United States, 53095
    - Froedtert West Bend Hospital/Kraemer Cancer Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Medical Center - Weston
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Aspirus Cancer Care - Wisconsin Rapids
- Wyoming
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis
Tumor site: Rectum; =< 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
* Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for >= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for >= 6 months after the last treatment
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (or Karnofsky >= 60%)
Absolute neutrophil count (ANC) >= 1,500/mm^3
Platelet count >= 100,000/mm
Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 50 mL/min
^3
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN)
No upper rectal tumors (distal margin of tumor > 12 cm from the anal verge)
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
Human immunodeficiency virus HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better
Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (LCRT, FOLFOX or CAPOX) Patients receive long-course chemoradiation therapy on study and then receive either: FOLFOX regimen consisting of leucovorin IV, fluorouracil IV, and oxaliplatin IV or CAPOX consisting of capecitabine PO, and oxaliplatin IV on study. Patients undergo CT scan, MRI, and biospecimen collection throughout the trial. Patients also undergo sigmoidoscopy throughout the trial and biopsy during screening.	Drug: Oxaliplatin Given IV Drug: Capecitabine Given PO Drug: 5-fluorouracil Given IV Drug: Leucovorin calcium Given IV Radiation: Long Course Chemoradiotherapy Receive LCRT Procedure: Computed Tomography undergo CT Procedure: Magnetic Resonance Imaging undergo MRI Procedure: Sigmoidoscopy undergo sigmoidoscopy Procedure: biopsy undergo biopsy
Experimental: Group II (LCRT, FOLFIRINOX) Patients receive long-course chemoradiation therapy on study and then receive FOLFIRINOX regimen consisting of leucovorin IV, fluorouracil IV, irinotecan IV, and oxaliplatin IV on study. Patients undergo CT scan, MRI scan, and blood specimen collection throughout the trial. Patients undergo sigmoidoscopy throughout the trial and biopsy during screening.	Drug: Oxaliplatin Given IV Drug: Irinotecan Given IV Drug: Capecitabine Given PO Drug: 5-fluorouracil Given IV Drug: Leucovorin calcium Given IV Radiation: Long Course Chemoradiotherapy Receive LCRT Procedure: Computed Tomography undergo CT Procedure: Magnetic Resonance Imaging undergo MRI Procedure: Sigmoidoscopy undergo sigmoidoscopy Procedure: biopsy undergo biopsy

Participant Group / Arm

Intervention / Treatment

Active Comparator: Group I (LCRT, FOLFOX or CAPOX)

Patients receive long-course chemoradiation therapy on study and then receive either: FOLFOX regimen consisting of leucovorin IV, fluorouracil IV, and oxaliplatin IV or CAPOX consisting of capecitabine PO, and oxaliplatin IV on study. Patients undergo CT scan, MRI, and biospecimen collection throughout the trial. Patients also undergo sigmoidoscopy throughout the trial and biopsy during screening.

Drug: Oxaliplatin

Given IV

Drug: Capecitabine

Given PO

Drug: 5-fluorouracil

Given IV

Drug: Leucovorin calcium

Given IV

Radiation: Long Course Chemoradiotherapy

Receive LCRT

Procedure: Computed Tomography

undergo CT

Procedure: Magnetic Resonance Imaging

undergo MRI

Procedure: Sigmoidoscopy

undergo sigmoidoscopy

Procedure: biopsy

undergo biopsy

Experimental: Group II (LCRT, FOLFIRINOX)

Patients receive long-course chemoradiation therapy on study and then receive FOLFIRINOX regimen consisting of leucovorin IV, fluorouracil IV, irinotecan IV, and oxaliplatin IV on study. Patients undergo CT scan, MRI scan, and blood specimen collection throughout the trial. Patients undergo sigmoidoscopy throughout the trial and biopsy during screening.

Drug: Oxaliplatin

Given IV

Drug: Irinotecan

Given IV

Drug: Capecitabine

Given PO

Drug: 5-fluorouracil

Given IV

Drug: Leucovorin calcium

Given IV

Radiation: Long Course Chemoradiotherapy

Receive LCRT

Procedure: Computed Tomography

undergo CT

Procedure: Magnetic Resonance Imaging

undergo MRI

Procedure: Sigmoidoscopy

undergo sigmoidoscopy

Procedure: biopsy

undergo biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clincal Complete Response (cCR) Rates Time Frame: Up to 5 years	efined as the number of patients who achieved cCR at the end of total neoadjuvant therapy (TNT) divided by number of patients included in the analysis population. This endpoint will be assessed within 8-12 weeks after completion of TNT. If there is a cCR, then the patient will be counted in the numerator. If there is a near-complete response (nCR) then a re-evaluation within 4-8 weeks will be performed. If the tumor has evolved to a cCR, then the patient will be counted in the numerator. Otherwise, the patient will be deemed as NOT achieving cCR status. divided by number of patients included in the analysis population.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival (DFS) rate Time Frame: rom date of randomization, assessed up to 5 years	Defined as the time from date of randomization to the date of first occurrence of the following events: death due to all causes, tumor that recurs locally after an R0 total mesorectal excision (TME), tumor that regrows after an initial apparent clinical and radiological CR and cannot be surgically removed with an R0 TME, and M1 disease diagnosed at any point after the initiation of treatment.	rom date of randomization, assessed up to 5 years
Organ-preservation-time (OPT) Time Frame: From date of randomization, assessed up to 5 years	Defined as time from the date of randomization to the date of the first occurrence of the following events: TME performed or attempted, tumor that regrows after an initial apparent clinical and radiological complete response (CR), and death due to all causes.	From date of randomization, assessed up to 5 years
Time to distant metastasis (TDM) Time Frame: From the date of randomization to the date of first documented distant metastasis, assessed up to 5 years	Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.	From the date of randomization to the date of first documented distant metastasis, assessed up to 5 years
Overall survival (OS) Time Frame: From the date of randomization to the date of death due to all causes, assessed up to 5 years	Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.	From the date of randomization to the date of death due to all causes, assessed up to 5 years
Incidence of adverse events (AEs) Time Frame: Up to 5 years	Defined as the proportion of patients experienced at least one Grade 3, Grade 4, or Grade 5 of each type of AE. The overall adverse event rates for grade 3 or higher adverse events will be compared between two treatment groups using Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).	Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: J. Joshua Smith, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2033

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A022104
U10CA180821 (U.S. NIH Grant/Contract)
NCI-2022-07800 (Other Identifier: NCI)
NRG-GI010 (Other Identifier: NRG Oncology)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Stage III Rectal Cancer AJCC v8

Clinical Trials on Oxaliplatin

Search Similar Trials

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