Recruiting
Phase 3

Neoadjuvant Chemotherapy vs. Chemoradiotherapy

Sponsor:

Canadian Cancer Trials Group

Code:

NCT06205485

Conditions

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Leucovorin

Oxaliplatin

Fluoruracil

Capecitabine

Radiation

Study Details

Brief summary:

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

Conditions

Rectal Cancer

Study ID

NCT06205485

Start date

Jun 26, 2024

Status verified date

Jan, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jan 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.
  • MRI stage cT1 not eligible for transanal surgery or cT2-T3ab\*. \* T3a: <1mm depth invasion, T3b: 1-5mm depth of invasion.
  • cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).
  • M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.
  • Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.
  • Medically fit to undergo radical TME surgery as per treating surgeon's decision.
  • Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French or Spanish.
  • Age of at least 18 years.
  • No contraindications to protocol chemotherapy.
  • Adequate normal organ and marrow function: ANC ≥ x 10\^9/L; platelet count ≥ 100 x 10\^9/L; bilirubin < 1.5 UNL, excluding Gilbert's syndrome; Estimated creatinine clearance of ≥ 50ml/min
  • Patient must have an ECOG performance of <2 (or Karnofsty ≥ 60%).
  • Must be accessible for treatment and follow-up
  • Males and females of reproductive potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

Exclusion Criteria:

  • Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology.
  • Patients with visible pelvic sidewall nodes on MRI.
  • Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.
  • Previous pelvic radiation for any reason, including brachytherapy alone.
  • Patients who have had primary lesion excised prior to enrollment. If a patient has had partial excision prior to enrollment, there must be gross residual disease endoscopically for patient to be eligible.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Prior treatment for rectal cancer.
  • Patients with known dihydropyrimidine dehydrogenase deficiency (DYPD).
  • Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • Any contra-indications to undergo MRI imaging.
  • Presence of anterior lesions above or near peritoneal reflection rendering the patient ineligible for a transanal tumour excision.
  • T3 tumours invading or abutting the internal sphincter.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: FOLFOX OR CAPOX

FOLFOX= Six cycles of modified FOLFOX consisting of leucovorin, oxaliplatin and bolus fluoruracil (optional), infusional fluorouracil.

CAPOX= Capecitabine twice daily for 14 days and Oxaliplatin on day 1

active comparator: ChemoRT

Standard dose of infusional 5-Fluorouracil/capecitabine and radiation

Interventions

Leucovorin

400 mg/m2

Oxaliplatin

85 mg/m2 or 130 mg/m2 on day 1

Fluoruracil

bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2

Capecitabine

1,000 mg/m2 twice daily for 14 days

Radiation

54 Gy (27-30 fractions)

Primary outcome measure

  • Clinical response rate upon re-staging [ Time Frame: 6 years ]
  • Quality of Life defined using the LARS score [ Time Frame: 6 years ]

Central Contacts and Locations

Central contacts

Locations

Cancer Center at Saint Joseph's

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Principal Investigator:

Shahzad Siddique

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Jason A. Zell

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Joshua P. Schiff

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Joshua P. Schiff

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Jason A. Zell

Mission Hope Medical Oncology - Santa Maria

Recruiting

Santa Maria, California, United States, 93444

Contacts

Principal Investigator:

Shahzad Siddique

Beebe South Coastal Health Campus

Recruiting

Millville, Delaware, United States, 19967

Contacts

Principal Investigator:

Gregory A. Masters

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Beebe Health Campus

Recruiting

Rehoboth Beach, Delaware, United States, 19971

Contacts

Principal Investigator:

Gregory A. Masters

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Patrick S. Sullivan

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Patrick S. Sullivan

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Patrick S. Sullivan

Rush-Copley Medical Center

Recruiting

Aurora, Illinois, United States, 60504

Contacts

Principal Investigator:

Prem Sobti

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Aparna Kalyan

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Prem Sobti

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Aparna Kalyan

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Prem Sobti

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Aparna Kalyan

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Prem Sobti

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Prem Sobti

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Aparna Kalyan

Northwest Cancer Center - Crown Point

Recruiting

Crown Point, Indiana, United States, 46307

Contacts

Principal Investigator:

Prem Sobti

Northwest Oncology LLC

Recruiting

Dyer, Indiana, United States, 46311

Contacts

Site Public Contact

219-924-8178

Principal Investigator:

Prem Sobti

Northwest Cancer Center - Hobart

Recruiting

Hobart, Indiana, United States, 46342

Contacts

Site Public Contact

219-947-1795

Principal Investigator:

Prem Sobti

Saint Mary Medical Center

Recruiting

Hobart, Indiana, United States, 46342

Contacts

Principal Investigator:

Prem Sobti

The Community Hospital

Recruiting

Munster, Indiana, United States, 46321

Contacts

Site Public Contact

219-836-3349

Principal Investigator:

Prem Sobti

Northwest Cancer Center - Valparaiso

Recruiting

Valparaiso, Indiana, United States, 46383

Contacts

Principal Investigator:

Prem Sobti

Ochsner Hematology Oncology North Shore - Covington (West Region)

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Principal Investigator:

Jonathan D. Mizrahi

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Principal Investigator:

Sanda A. Tan

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Principal Investigator:

Jonathan D. Mizrahi

Beverly Hospital

Recruiting

Beverly, Massachusetts, United States, 01915

Contacts

Site Public Contact

978-922-3000

Principal Investigator:

Brian Labadie

Lahey Clinic

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Principal Investigator:

Brian Labadie

Addison Gilbert Hospital

Recruiting

Gloucester, Massachusetts, United States, 01930

Contacts

Site Public Contact

978-283-4000

Principal Investigator:

Brian Labadie

Henry Ford Cancer Institute-Downriver

Recruiting

Brownstown, Michigan, United States, 48183

Contacts

Principal Investigator:

Maria Diab

Henry Ford Macomb Hospital-Clinton Township

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Principal Investigator:

Maria Diab

Henry Ford Medical Center-Fairlane

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Principal Investigator:

Maria Diab

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Maria Diab

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

Allegiance Health

Recruiting

Jackson, Michigan, United States, 49201

Contacts

Principal Investigator:

Maria Diab

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Principal Investigator:

Kathleen Y. Butler

Henry Ford Medical Center-Columbus

Recruiting

Novi, Michigan, United States, 48377

Contacts

Principal Investigator:

Maria Diab

Henry Ford West Bloomfield Hospital

Recruiting

West Bloomfield, Michigan, United States, 48322

Contacts

Principal Investigator:

Maria Diab

Henry Ford Wyandotte Hospital

Recruiting

Wyandotte, Michigan, United States, 48192

Contacts

Site Public Contact

nhay@hfhs.org

Principal Investigator:

Maria Diab

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Principal Investigator:

Daniel Almquist

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Principal Investigator:

John A. Ellerton

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Gabriel A. Brooks

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Martin R. Weiser

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Martin R. Weiser

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Martin R. Weiser

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Lara McKean Baste

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Steven Nurkin

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Martin R. Weiser

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Martin R. Weiser

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Martin R. Weiser

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Fergal Fleming

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Martin R. Weiser

Wilmot Cancer Institute at Webster

Recruiting

Webster, New York, United States, 14580

Contacts

Principal Investigator:

Fergal Fleming

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Principal Investigator:

Michael D. Honaker

Sanford Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Principal Investigator:

Daniel Almquist

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Principal Investigator:

Tarek M. Sabagh

University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Ian M. Paquette

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Philip S. Bauer

Premier Blood and Cancer Center

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Site Public Contact

937-276-8320

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital North

Recruiting

Dayton, Ohio, United States, 45415

Contacts

Principal Investigator:

Tarek M. Sabagh

Atrium Medical Center-Middletown Regional Hospital

Recruiting

Franklin, Ohio, United States, 45005-1066

Contacts

Principal Investigator:

Tarek M. Sabagh

Miami Valley Cancer Care and Infusion

Recruiting

Greenville, Ohio, United States, 45331

Contacts

Site Public Contact

937-569-7515

Principal Investigator:

Tarek M. Sabagh

Upper Valley Medical Center

Recruiting

Troy, Ohio, United States, 45373

Contacts

Principal Investigator:

Tarek M. Sabagh

University of Cincinnati Cancer Center-West Chester

Recruiting

West Chester, Ohio, United States, 45069

Contacts

Principal Investigator:

Ian M. Paquette

Clackamas Radiation Oncology Center

Recruiting

Clackamas, Oregon, United States, 97015

Contacts

Principal Investigator:

Dan S. Zuckerman

Legacy Mount Hood Medical Center

Recruiting

Gresham, Oregon, United States, 97030

Contacts

Site Public Contact

503-413-2150

Principal Investigator:

Mei Dong

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Principal Investigator:

Dan S. Zuckerman

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Principal Investigator:

Charles W. Drescher

Legacy Good Samaritan Hospital and Medical Center

Recruiting

Portland, Oregon, United States, 97210

Contacts

Site Public Contact

800-220-4937cancer@lhs.org

Principal Investigator:

Mei Dong

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Dan S. Zuckerman

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Dan S. Zuckerman

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080trials@ohsu.edu

Principal Investigator:

Hagen F. Kennecke

Legacy Meridian Park Hospital

Recruiting

Tualatin, Oregon, United States, 97062

Contacts

Site Public Contact

503-413-1742

Principal Investigator:

Mei Dong

Christiana Care Health System-Concord Health Center

Recruiting

Chadds Ford, Pennsylvania, United States, 19317

Contacts

Principal Investigator:

Gregory A. Masters

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

Site Public Contact

717-531-3779CTO@hmc.psu.edu

Principal Investigator:

Nelson S. Yee

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Principal Investigator:

Daniel Almquist

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Principal Investigator:

Daniel Almquist

The West Clinic - Wolf River

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Principal Investigator:

Noam A. VanderWalde

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Cathy Eng

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Tsuyoshi Konishi

Scott and White Memorial Hospital

Recruiting

Temple, Texas, United States, 76508

Contacts

Site Public Contact

254-724-5407

Principal Investigator:

Lucas Wong

Dartmouth Cancer Center - North

Recruiting

Saint Johnsbury, Vermont, United States, 05819

Contacts

Principal Investigator:

Gabriel A. Brooks

FHCC Overlake

Recruiting

Bellevue, Washington, United States, 98004

Contacts

Site Public Contact

425-454-2148

Principal Investigator:

Nancy Y. Cui

FHCC at EvergreenHealth

Recruiting

Kirkland, Washington, United States, 98034

Contacts

Site Public Contact

425-899-6000

Principal Investigator:

Adam Diehl

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Principal Investigator:

Huong T. Pham

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Stacey A. Cohen

FHCC at Northwest Hospital

Recruiting

Seattle, Washington, United States, 98133

Contacts

Site Public Contact

206-606-5800

Principal Investigator:

Nikhil V. Kamat

Legacy Cancer Institute Medical Oncology and Day Treatment

Recruiting

Vancouver, Washington, United States, 98684

Contacts

Site Public Contact

oncologyresearch@lhs.org

Principal Investigator:

Mei Dong

Legacy Salmon Creek Hospital

Recruiting

Vancouver, Washington, United States, 98686

Contacts

Site Public Contact

503-413-2150

Principal Investigator:

Mei Dong

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Principal Investigator:

Rohit Sharma

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Principal Investigator:

Rohit Sharma

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, United States, 54548

Contacts

Principal Investigator:

Rohit Sharma

Marshfield Medical Center-Rice Lake

Recruiting

Rice Lake, Wisconsin, United States, 54868

Contacts

Principal Investigator:

Rohit Sharma

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Principal Investigator:

Rohit Sharma

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Principal Investigator:

Rohit Sharma

BCCA-Vancouver Cancer Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Site Public Contact

888-939-3333

Principal Investigator:

Jonathan M. Loree

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Principal Investigator:

Eric Hyun

Doctor H. Bliss Murphy Cancer Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Site Public Contact

709-777-7589

Principal Investigator:

Teri L. Stuckless

London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 4L6

Contacts

Site Public Contact

519-685-8600

Principal Investigator:

Terry M. Zwiep

Ottawa Hospital and Cancer Center-General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Site Public Contact

613-761-4395

Principal Investigator:

Kristopher Dennis

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Site Public Contact

514-252-3400

Principal Investigator:

Mikael Soucisse

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

Contacts

Site Public Contact

306-766-2213

Principal Investigator:

Mussawar Iqbal

Saskatoon Cancer Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

Contacts

Site Public Contact

306-655-2914

Principal Investigator:

Shahid Ahmed

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Jul 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-07-14.