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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05610163
Other study ID # A022104
Secondary ID NCI-2022-07800U1
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 8, 2022
Est. completion date September 2032

Study information

Verified date May 2024
Source Alliance for Clinical Trials in Oncology
Contact J. Joshua Smith, MD
Phone 212-639-5807
Email smithj5@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 312
Est. completion date September 2032
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Capecitabine
Given PO
5-fluorouracil
Given IV
Leucovorin calcium
Given IV
Irinotecan
Given IV
Oxaliplatin
Given IV
Radiation:
Long Course Chemoradiotherapy
Receive LCRT
Procedure:
Computed Tomography
undergo CT
Magnetic Resonance Imaging
undergo MRI
Sigmoidoscopy
undergo sigmoidoscopy
biopsy
undergo biopsy

Locations

Country Name City State
Puerto Rico Cancer Center-Metro Medical Center Bayamon Bayamon
Puerto Rico Doctors Cancer Center Manati
Puerto Rico Centro Comprensivo de Cancer de UPR San Juan
Puerto Rico San Juan City Hospital San Juan
Puerto Rico San Juan Community Oncology Group San Juan
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Atrium Health Stanly/LCI-Albemarle Albemarle North Carolina
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States AdventHealth Altamonte Altamonte Springs Florida
United States UPMC Altoona Altoona Pennsylvania
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States AnMed Health Cancer Center Anderson South Carolina
United States Mission Cancer and Blood - Ankeny Ankeny Iowa
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States PCR Oncology Arroyo Grande California
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northwest Wisconsin Cancer Center Ashland Wisconsin
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Rush - Copley Medical Center Aurora Illinois
United States UCHealth University of Colorado Hospital Aurora Colorado
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States MedStar Good Samaritan Hospital Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Advocate Good Shepherd Hospital Barrington Illinois
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States OSF Saint Joseph Medical Center Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States University of Michigan - Brighton Center for Specialty Care Brighton Michigan
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn New York
United States Henry Ford Cancer Institute-Downriver Brownstown Michigan
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cooper Hospital University Medical Center Camden New Jersey
United States UPMC Camp Hill Camp Hill Pennsylvania
United States Aultman Health Foundation Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Trinity Health Medical Center - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Carlisle Regional Cancer Center Carlisle Pennsylvania
United States Mercy Cancer Center - Carmichael Carmichael California
United States Mercy San Juan Medical Center Carmichael California
United States Caro Cancer Center Caro Michigan
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Duke Cancer Institute Cary Cary North Carolina
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Saint Mary's Hospital Centralia Illinois
United States Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Atrium Health Pineville/LCI-Pineville Charlotte North Carolina
United States Atrium Health University City/LCI-University Charlotte North Carolina
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Levine Cancer Institute-Ballantyne Charlotte North Carolina
United States Levine Cancer Institute-SouthPark Charlotte North Carolina
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Advocate Illinois Masonic Medical Center Chicago Illinois
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Northwestern University Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Morton Plant Hospital Clearwater Florida
United States Wake Forest University at Clemmons Clemmons North Carolina
United States MetroHealth Medical Center Cleveland Ohio
United States Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee
United States Memorial Hospital North Colorado Springs Colorado
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Saint Francis Cancer Center Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Atrium Health Cabarrus/LCI-Concord Concord North Carolina
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States MD Anderson in The Woodlands Conroe Texas
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Ochsner Hematology Oncology North Shore - Covington (West Region) Covington Louisiana
United States Greater Regional Medical Center Creston Iowa
United States Northwest Cancer Center - Main Campus Crown Point Indiana
United States AMG Crystal Lake - Oncology Crystal Lake Illinois
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern Simmons Cancer Center - RedBird Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle at The Riverfront Danville Illinois
United States Dayton Physician LLC - Englewood Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Porter Adventist Hospital Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States UCHealth - Cherry Creek Denver Colorado
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Illinois CancerCare-Dixon Dixon Illinois
United States Advocate Good Samaritan Hospital Downers Grove Illinois
United States City of Hope Comprehensive Cancer Center Duarte California
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Duke University Medical Center Durham North Carolina
United States Northwest Oncology LLC Dyer Indiana
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Saint Elizabeth Healthcare Edgewood Edgewood Kentucky
United States Fairview Southdale Hospital Edina Minnesota
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Advocate Sherman Hospital Elgin Illinois
United States Mercy Cancer Center - Elk Grove Elk Grove California
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Saint Vincent Hospital Erie Pennsylvania
United States UPMC Hillman Cancer Center Erie Erie Pennsylvania
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Inova Fair Oaks Hospital Fairfax Virginia
United States Inova Schar Cancer Institute Fairfax Virginia
United States Inova Fairfax Hospital Falls Church Virginia
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Farmington Health Center Farmington Utah
United States Parkland Health Center - Farmington Farmington Missouri
United States Beaumont Hospital - Farmington Hills Farmington Hills Michigan
United States UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States The New York Hospital Medical Center of Queens Flushing New York
United States Levine Cancer Institute - Rutherford Forest City North Carolina
United States Holy Cross Hospital Fort Lauderdale Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Saint Elizabeth Healthcare Fort Thomas Fort Thomas Kentucky
United States Parkview Regional Medical Center Fort Wayne Indiana
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Essentia Health - Fosston Fosston Minnesota
United States Dana-Farber Cancer Institute at Foxborough Foxboro Massachusetts
United States Beebe South Coastal Health Campus Frankford Delaware
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Washington Hospital Fremont California
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Levine Cancer Institute-Gaston Gastonia North Carolina
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Tidelands Georgetown Memorial Hospital Georgetown South Carolina
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States The West Clinic - Wolf River Germantown Tennessee
United States Glens Falls Hospital Glens Falls New York
United States SCL Health Cancer Centers of Colorado - Lutheran Medical Center Golden Colorado
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Northwell Health Cancer Institute at Huntington Greenlawn New York
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States East Carolina University Greenville North Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Baptist Cancer Center-Grenada Grenada Mississippi
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania
United States Memorial Sloan Kettering Westchester Harrison New York
United States Hartford Hospital Hartford Connecticut
United States Ingalls Memorial Hospital Harvey Illinois
United States Essentia Health-Hayward Clinic Hayward Wisconsin
United States Advocate South Suburban Hospital Hazel Crest Illinois
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States UCHealth Highlands Ranch Hospital Highlands Ranch Colorado
United States University of North Carolina-Hillsborough Campus Hillsborough North Carolina
United States Northwest Cancer Center - Hobart Hobart Indiana
United States Saint Mary Medical Center Hobart Indiana
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States Ben Taub General Hospital Houston Texas
United States Lyndon Baines Johnson General Hospital Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson West Houston Houston Texas
United States IRMC Cancer Center Indiana Pennsylvania
United States City of Hope at Irvine Lennar Irvine California
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Mayo Clinic in Florida Jacksonville Florida
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Jefferson Hospital Jefferson Hills Pennsylvania
United States UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States CHI Health Good Samaritan Kearney Nebraska
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kingman Regional Medical Center Kingman Arizona
United States FHCC at EvergreenHealth Kirkland Washington
United States AdventHealth Kissimmee Kissimmee Florida
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Saint Anthony Hospital Lakewood Colorado
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States MD Anderson League City League City Texas
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States Inova Loudoun Hospital Leesburg Virginia
United States Beebe Medical Center Lewes Delaware
United States Saint Joseph Hospital Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States AMG Libertyville - Oncology Libertyville Illinois
United States Condell Memorial Hospital Libertyville Illinois
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Atrium Health Lincoln/LCI-Lincolnton Lincolnton North Carolina
United States Littleton Adventist Hospital Littleton Colorado
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States The Dana-Farber Cancer Institute at Londonderry Londonderry New Hampshire
United States Longmont United Hospital Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Los Angeles General Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States Saint Joseph's Hospital-North Lutz Florida
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States North Shore University Hospital Manhasset New York
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Sovah Health Martinsville Martinsville Virginia
United States Levine Cancer Institute - Union West Matthews North Carolina
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania
United States UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin
United States Mercy Cancer Center Merced California
United States Midstate Medical Center Meriden Connecticut
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Dana Farber-Merrimack Valley Methuen Massachusetts
United States Garnet Health Medical Center Middletown New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford Massachusetts
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States NYU Langone Hospital - Long Island Mineola New York
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Center Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Atrium Health Union/LCI-Union Monroe North Carolina
United States Forbes Hospital Monroeville Pennsylvania
United States UPMC Cancer Center - Monroeville Monroeville Pennsylvania
United States UPMC Hillman Cancer Center - Monroeville Monroeville Pennsylvania
United States Monticello Cancer Center Monticello Minnesota
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States UPMC Hillman Cancer Center in Coraopolis Moon Pennsylvania
United States Northern Westchester Hospital Mount Kisco New York
United States UPMC Hillman Cancer Center - Part of Frick Hospital Mount Pleasant Pennsylvania
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Skagit Regional Health Cancer Care Center Mount Vernon Washington
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States The Community Hospital Munster Indiana
United States Women's Diagnostic Center - Munster Munster Indiana
United States MUSC Health Tidelands Health Radiation Therapy Center Murrells Inlet South Carolina
United States Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon Pennsylvania
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Providence Queen of The Valley Napa California
United States Edward Hospital/Cancer Center Naperville Illinois
United States Vanderbilt Breast Center at One Hundred Oaks Nashville Tennessee
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States UPMC Cancer Center-Natrona Heights Natrona Heights Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi
United States The Hospital of Central Connecticut New Britain Connecticut
United States UPMC Hillman Cancer Center - New Castle New Castle Pennsylvania
United States Long Island Jewish Medical Center New Hyde Park New York
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Lenox Hill Hospital New York New York
United States Manhattan Eye Ear and Throat Hospital New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai Hospital New York New York
United States Mount Sinai West New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States NYP/Weill Cornell Medical Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Providence Newberg Medical Center Newberg Oregon
United States Ascension Providence Hospitals - Novi Novi Michigan
United States Henry Ford Medical Center-Columbus Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States HSHS Saint Elizabeth's Hospital O'Fallon Illinois
United States Drexel Town Square Health Center Oak Creek Wisconsin
United States Advocate Christ Medical Center Oak Lawn Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States AdventHealth East Orlando Orlando Florida
United States AdventHealth Orlando Orlando Florida
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Upstate Cancer Center at Oswego Oswego New York
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
United States Advocate High Tech Medical Park Palos Heights Illinois
United States The Valley Hospital - Luckow Pavilion Paramus New Jersey
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States Parker Adventist Hospital Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Jefferson Torresdale Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Mayo Clinic Hospital in Arizona Phoenix Arizona
United States Avera Cancer Institute at Pierre Pierre South Dakota
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States UPMC-Mercy Hospital Pittsburgh Pennsylvania
United States UPMC-Passavant Hospital Pittsburgh Pennsylvania
United States UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania
United States UPMC-Saint Margaret Pittsburgh Pennsylvania
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States Edward Hospital/Cancer Center?Plainfield Plainfield Illinois
United States Michigan Healthcare Professionals Pontiac Pontiac Michigan
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Illinois CancerCare-Princeton Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Duke Raleigh Hospital Raleigh North Carolina
United States Queens Cancer Center Rego Park New York
United States Beebe Health Campus Rehoboth Beach Delaware
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States Reid Health Richmond Indiana
United States VCU Massey Cancer Center at Stony Point Richmond Virginia
United States Virginia Cancer Institute Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Valley Health System Ridgewood Campus Ridgewood New Jersey
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Levine Cancer Institute-Rock Hill Rock Hill South Carolina
United States Rock Hill Radiation Therapy Center Rock Hill South Carolina
United States Mercy Cancer Center - Rocklin Rocklin California
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Mercy Cancer Center - Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Saint Anthony's Hospital Cancer Care Center Saint Petersburg Florida
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salinas Valley Memorial Salinas California
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States University of Utah Sugarhouse Health Center Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Essentia Health Sandstone Sandstone Minnesota
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Providence Medical Foundation - Santa Rosa Santa Rosa California
United States Memorial Health University Medical Center Savannah Georgia
United States FHCC South Lake Union Seattle Washington
United States Fred Hutchinson Cancer Center Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania
United States Sidney Kimmel Cancer Center Washington Township Sewell New Jersey
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Atrium Health Cleveland/LCI-Cleveland Shelby North Carolina
United States Welch Cancer Center Sheridan Wyoming
United States Saint Michael Cancer Center Silverdale Washington
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Phelps Memorial Hospital Center Sleepy Hollow New York
United States City of Hope South Pasadena South Pasadena California
United States Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth Massachusetts
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States Spartanburg Medical Center Spartanburg South Carolina
United States Essentia Health-Spooner Clinic Spooner Wisconsin
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States MD Anderson in Sugar Land Sugar Land Texas
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Essentia Health Saint Mary's Hospital - Superior Superior Wisconsin
United States State University of New York Upstate Medical University Syracuse New York
United States SUNY Upstate Medical Center-Community Campus Syracuse New York
United States Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Holy Name Hospital Teaneck New Jersey
United States Scott and White Memorial Hospital Temple Texas
United States City of Hope South Bay Torrance California
United States Dayton Physicians LLC - Troy Troy Ohio
United States William Beaumont Hospital - Troy Troy Michigan
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States MGC Hematology Oncology-Union Union South Carolina
United States Memorial Sloan Kettering Nassau Uniondale New York
United States UPMC Cancer Center-Uniontown Uniontown Pennsylvania
United States UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania
United States City of Hope Upland Upland California
United States Carle Cancer Center Urbana Illinois
United States Northwest Cancer Center - Valparaiso Valparaiso Indiana
United States Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver Washington
United States Legacy Salmon Creek Hospital Vancouver Washington
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Upstate Cancer Center at Verona Verona New York
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States George Washington University Medical Center Washington District of Columbia
United States Illinois CancerCare - Washington Washington Illinois
United States MedStar Georgetown University Hospital Washington District of Columbia
United States MedStar Washington Hospital Center Washington District of Columbia
United States UPMC Cancer Center-Washington Washington Pennsylvania
United States UPMC Washington Hospital Radiation Oncology Washington Pennsylvania
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Wilmot Cancer Institute at Webster Webster New York
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Chester County Hospital West Chester Pennsylvania
United States Lexington Medical Center West Columbia South Carolina
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States William E Kahlert Regional Cancer Center/Sinai Hospital Westminster Maryland
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Valley Health System-Hematology/Oncology Westwood New Jersey
United States Wexford Health and Wellness Pavilion Wexford Pennsylvania
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Wake Forest Baptist Health - Wilkes Medical Center Wilkesboro North Carolina
United States Divine Providence Hospital Williamsport Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Woodland Memorial Hospital Woodland California
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Avera Cancer Institute at Yankton Yankton South Dakota
United States UPMC Memorial York Pennsylvania
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clincal Complete Response (cCR) Rates 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 Disease-free survival (DFS) rate 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
Secondary Organ-preservation-time (OPT) 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
Secondary Time to distant metastasis (TDM) 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
Secondary Overall survival (OS) 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
Secondary Incidence of adverse events (AEs) 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
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