AzTrials
AzTrials

Stage II Rectal Cancer AJCC v8Phase 2/3JANUSNCT05610163

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 and Continuing Response

A Phase 2/3 study testing Capecitabine, 5-fluorouracil and Leucovorin calcium in people with Stage II Rectal Cancer AJCC v8 and Stage III Rectal Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 685 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II/III trial compares the effect of usual treatment approach alone (FOLFOX or CAPOX after chemoradiation) with using FOLFIRINOX after chemoradiation in patients with stage II-III rectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capecitabine, 5-fluorouracil and Leucovorin calcium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
760 participants
Where
685 sitesin 2 countries
Study dates
8 Dec 2022to 1 Jul 2037
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic Documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR)
  • 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; distal edge of the tumor =< 12cm from the anal verge (as determined by surgeon's endoscopic assessment; MRI can be used to compliment this information, but endoscopy should be the primary means of assessment)
  • No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed. No local approaches to excising the rectal cancer (even if done for diagnostic purposes) are allowed (e.g., transanal excision [open or minimally invasive], local excision, endoscopic submucosal dissection or endoscopic submucosal resection).
  • 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
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  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (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 (i.e., distal portion of tumor must be => 12 cm from the anal verge)
  • No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis or prior endoscopic submucosal dissection
  • No known mismatch repair deficient rectal adenocarcinoma
  • 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
  • Testing for dihydropyrimidine dehydrogenase (DPD) deficiency is not required. However, when available, patients with complete lack of DPD should not be treated with fluoropyrimidines (such patients must not be enrolled or if initiated on therapy and noted to have fluoropyrimidine related toxicities be taken off protocol; dose reductions for patients with partial deficiency may be done per local guidelines
  • 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
  • Once systemic chemotherapy has been completed and the patient is either in surveillance or being considered for surgery then medically necessary CYP3A4 medications can be resume

Who cannot join

None listed.

Trial locations and contacts

685 sites in 2 countries.

306 sites in 2 countries

United States300 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Atrium Health Stanly/LCI-Albemarle

    Albemarle, North Carolina, 28002

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • AdventHealth Altamonte

    Altamonte Springs, Florida, 32701

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Advocate Outpatient Center - Aurora

    Aurora, Illinois, 60506

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • OSF Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • United Hospital Center

    Bridgeport, West Virginia, 26330

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Keck Medicine of USC Buena Park

    Buena Park, California, 90621

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • UPMC Camp Hill

    Camp Hill, Pennsylvania, 17011

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Caro Cancer Center

    Caro, Michigan, 48723

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • AdventHealth Celebration

    Celebration, Florida, 34747

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

  • Levine Cancer Institute-SouthPark

    Charlotte, North Carolina, 28211

  • Atrium Health University City/LCI-University

    Charlotte, North Carolina, 28262

  • Levine Cancer Institute-Ballantyne

    Charlotte, North Carolina, 28277

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Wake Forest University at Clemmons

    Clemmons, North Carolina, 27012

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Baptist Health Corbin

    Corbin, Kentucky, 40701

  • Ochsner Hematology Oncology North Shore - Covington (West Region)

    Covington, Louisiana, 70433

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Northwest Cancer Center - Main Campus

    Crown Point, Indiana, 46307

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

  • UPMC Western Maryland

    Cumberland, Maryland, 21502

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • UCHealth - Cherry Creek

    Denver, Colorado, 80206

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Saint Elizabeth Healthcare Edgewood

    Edgewood, Kentucky, 41017

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Inova Fair Oaks Hospital

    Fairfax, Virginia, 22033

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Farmington Health Center

    Farmington, Utah, 84025

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • The New York Hospital Medical Center of Queens

    Flushing, New York, 11355

  • Levine Cancer Institute - Rutherford

    Forest City, North Carolina, 28043

  • Northwell Health Physicians Partners Radiation Medicine at Queens

    Forest Hills, New York, 11375

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Saint Elizabeth Healthcare Fort Thomas

    Fort Thomas, Kentucky, 41075

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Tarrant County Hospital District/JPS Health Network

    Fort Worth, Texas, 76104

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

  • Dana-Farber Cancer Institute at Foxborough

    Foxborough, Massachusetts, 02035

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Washington Hospital

    Fremont, California, 94538

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Levine Cancer Institute-Gaston

    Gastonia, North Carolina, 28054

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • The West Clinic - Wolf River

    Germantown, Tennessee, 38138

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

  • Lutheran Hospital - Cancer Centers of Colorado

    Golden, Colorado, 80401

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Northwell Health Cancer Institute at Huntington

    Greenlawn, New York, 11740

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • East Carolina University

    Greenville, North Carolina, 27834

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • UPMC Hillman Cancer Center in Greenville/UPMC Horizon

    Greenville, Pennsylvania, 16125

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Hi-Line Sletten Cancer Center

    Havre, Montana, 59501

  • Essentia Health-Hayward Clinic

    Hayward, Wisconsin, 54843

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • Hayworth Cancer Center

    High Point, North Carolina, 27262

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

  • University of North Carolina-Hillsborough Campus

    Hillsborough, North Carolina, 27278

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson West Houston

    Houston, Texas, 77079

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Allegiance Health

    Jackson, Michigan, 49201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Essentia Health - Jamestown Clinic

    Jamestown, North Dakota, 58401

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

Other trials in United States

Puerto Rico6 sites

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060

  • Doctors Cancer Center

    Manati, 00674

  • Pan American Center for Oncology Trials LLC

    San Juan, 00902

  • San Juan Community Oncology Group

    San Juan, 00917

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy Regarding Clinical Complete Response and Disease-free Survival in Patients With Locally Advanced Rectal Cancer

This phase II/III trial compares the effect of usual treatment approach alone (FOLFOX or CAPOX after chemoradiation) with using FOLFIRINOX after chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy regimens, such as FOLFIRINOX (folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, and oxaliplatin), or CAPOX (capecitabine and oxaliplatin) use more than one anticancer drug that 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 for the primary rectal tumor and lead to higher rates of clinical complete response (and thus a chance to avoid surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

Read the detailed description

PRIMARY OBJECTIVES:

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

II. To evaluate and compare disease-free survival (DFS) in patients with locally advanced rectal cancer treated with neoadjuvant LCRT followed by neoadjuvant mFOLFIRINOX versus neoadjuvant LCRT followed by neoadjuvant mFOLFOX6/CAPOX. (Phase III)

SECONDARY OBJECTIVES:

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

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

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

  1. To evaluate and compare sustained cCR between two treatment arms.

EXPLORATORY OBJECTIVE:

  1. 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.

ARM I:

LCRT: Patients undergo long-course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive either FOLFOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV bolus over 2-4 minutes and IV continuous infusion over 46-48 hours on day 1 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle or CAPOX consisting of capecitabine orally on days 1-14 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle. Treatment with FOLFOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity. Treatment with CAPOX repeats every 3 weeks for up to 5 cycles (15 weeks) in the absence of disease progression or unacceptable toxicity.

ARM II:

LCRT: Patients undergo long course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive FOLFIRINOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV continuous infusion over 46-48 hours on day 1 of each cycle, oxaliplatin IV over 2 hours on day 1 of each cycle, and irinotecan IV over 30-90 minutes on day 1 of each cycle) Treatment with FOLFIRINOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity.

All patients undergo CT scan, MRI scan, and collection of blood samples, and sigmoidoscopy throughout the trial and undergo biopsy during screening.

Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05610163
Study groupRoleWhat they receive
Arm I (LCRT, FOLFOX or CAPOX)Active comparatorLCRT: Patients undergo long-course chemoradiation therapy for up to 5 weeks. Consolidation: Patients receive either: FOLFOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV bolus over 2-4 minutes and IV continuous infusion over 46-48 hours on day 1 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle) or CAPOX (consisting of capecitabine PO on days 1-14 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle). Treatment with FOLFOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity. Treatment with CAPOX repeats every 3 weeks for up to 5 cycles (15 weeks) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, collection of blood samples and sigmoidoscopy throughout the trial and undergo biopsy during screening.
Receives: Drug: Capecitabine; Drug: 5-fluorouracil; Drug: Leucovorin calcium; Drug: Oxaliplatin; Radiation: Long Course Chemoradiotherapy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Sigmoidoscopy; Procedure: biopsy
Arm II (LCRT, FOLFIRINOX)ExperimentalLCRT: Patients undergo long-course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive FOLFIRINOX (consisting of leucovorin over 2 hours on day 1 of each cycle, fluorouracil IV continuous infusion over 46-48 hours on day 1 of each cycle, oxaliplatin IV over 2 hours on day 1 of each cycle, and irinotecan IV over 30-90 minutes on day 1 of each cycle). Treatment with FOLFIRINOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and collection of blood samples and sigmoidoscopy throughout the trial and undergo biopsy during screening.
Receives: Drug: Capecitabine; Drug: 5-fluorouracil; Drug: Leucovorin calcium; Drug: Irinotecan; Drug: Oxaliplatin; Radiation: Long Course Chemoradiotherapy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Sigmoidoscopy; Procedure: biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clincal Complete Response (cCR) Rates (Phase II)

    Defined 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 an nCR evolved to a cCR, then the patient will be counted in the numerator. Otherwise, the patient will be deemed as NOT achieving cCR status. Difference of proportions test will be conducted to compare cCR rate in the experimental arm to cCR rate in the control arm. If the one-sided p-value of the comparison is < 0.05 (difference in proportion > 9.3%), then we will conclude the cCR rate in the experimental arm is superior to the control arm.

    Measured: Up to 5 years

  2. Disease-free survival (DFS) rate (Phase III)

    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. Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.

    Measured: From date of randomization, assessed up to 5 years

Secondary outcomes (5)

  1. 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. Will be estimated, in each arm, using the method of Kaplan-Meier and treatment compared by a stratified Cox regression model.

    Measured: From date of randomization, assessed up to 5 years

  2. 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.

    Measured: From the date of randomization to the date of first documented distant metastasis, assessed up to 5 years

  3. Overall survival (OS)

    Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.

    Measured: From the date of randomization to the date of death due to all causes, assessed up to 5 years

  4. 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).

    Measured: Up to 5 years

  5. Sustained cCR

    Defined as a binary endpoint with two statuses: responder and non-responder. Responders are defined as those evaluable patients who achieved at least one of the following within 3 years after randomization:

    • Had TME and the pathologic outcome is pathologic complete response
    • Had a cCR, were on watch and wait (WW) with no regrowth and no distant metastases
    • Had nCR, were on WW with no regrowth and no distant metastases Non-responders are defined as all patients who did not meet the criteria as noted above for the responders.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2022
  2. Study start8 Dec 2022
  3. Primary completion1 Jul 2030 (estimated)
  4. Study completion1 Jul 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
760 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610163
Sponsor's protocol ID
A022104
Other IDs
U10CA180821, NCI-2022-07800, NRG-GI010
Acronym
JANUS
Status last verified
Sep 2026
First submitted
1 Nov 2022
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Raman S, Khalil MA, Eisenstein S, Lin M. Selected Abstracts. Dis Colon Rectum. 2026 Jul 1;69(7):1938-1942. doi: 10.1097/DCR.0000000000004250. Epub 2026 Apr 7. No abstract available.

    PubMed 42328901

  • Scott AJ, Kennedy EB, Berlin J, Brown G, Chalabi M, Cho MT, Cusnir M, Dorth J, George M, Kachnic LA, Kennecke HF, Loree JM, Morris VK, Perez RO, Smith JJ, Strickland MR, Gholami S. Management of Locally Advanced Rectal Cancer: ASCO Guideline. J Clin Oncol. 2024 Oct;42(28):3355-3375. doi: 10.1200/JCO.24.01160. Epub 2024 Aug 8.

    PubMed 39116386

  • Alvarez JA, Shi Q, Dasari A, Garcia-Aguilar J, Sanoff H, George TJ, Hong T, Yothers G, Philip P, Nelson G, Al Baghdadi T, Alese OB, Zambare W, Omer D, Verheij FS, Bercz A, Kim MJ, Buckley J, Williams H, George M, Garcia R, Gallagher P, O'Reilly EM, Meyerhardt JA, Crawley J, Shergill A, Horvat N, Romesser PB, Hall W, Smith JJ. Alliance A022104/NRG-GI010: The Janus Rectal Cancer Trial: a randomized phase II/III trial testing the efficacy of triplet versus doublet chemotherapy regarding clinical complete response and disease-free survival in patients with locally advanced rectal cancer. BMC Cancer. 2024 Jul 26;24(1):901. doi: 10.1186/s12885-024-12529-7.

    PubMed 39060961

  • Alvarez J, Shi Q, Dasari A, Garcia-Aguilar J, Sanoff H, George TJ, Hong TS, Yothers G, Philip PA, Nelson GD, Al Baghdadi T, Alese O, Zambare W, Omer DM, Verheij FS, Buckley J, Williams H, George M, Garcia R, O'Reilly EM, Meyerhardt JA, Shergill A, Horvat N, Romesser PB, Hall WA, Smith JJ. ALLIANCE A022104/NRG-GI010: The Janus Rectal Cancer Trial: a randomized phase II/III trial testing the efficacy of triplet versus doublet chemotherapy regarding clinical complete response and disease-free survival in patients with locally advanced rectal cancer. medRxiv [Preprint]. 2024 Apr 27:2024.04.25.24306396. doi: 10.1101/2024.04.25.24306396.

    PubMed 38712176

  • Langenfeld SJ, Davis BR, Vogel JD, Davids JS, Temple LKF, Cologne KG, Hendren S, Hunt S, Garcia Aguilar J, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Rectal Cancer 2023 Supplement. Dis Colon Rectum. 2024 Jan 1;67(1):18-31. doi: 10.1097/DCR.0000000000003057. Epub 2023 Aug 20. No abstract available.

    PubMed 37647138

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Capecitabine, 5-fluorouracil and Leucovorin calcium in people with Stage II Rectal Cancer AJCC v8 and Stage III Rectal Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 685 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 685 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clincal Complete Response (cCR) Rates (Phase II) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05610163, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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