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RECRUITING

NCT06205485

PHASE3

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Sponsor: Canadian Cancer Trials Group

View on ClinicalTrials.gov

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?

Official title: A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation Versus Chemoradiotherapy For Early Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-06-26

Completion Date

2030-06-30

Last Updated

2026-01-13

Healthy Volunteers

Conditions

Rectal Cancer

Interventions

DRUG

Leucovorin

400 mg/m2

DRUG

Oxaliplatin

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

DRUG

Fluoruracil

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

DRUG

Capecitabine

1,000 mg/m2 twice daily for 14 days

RADIATION

Radiation

54 Gy (27-30 fractions)

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.

Locations (100)

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Northwest Cancer Center - Main Campus

Crown Point, Indiana, United States

Northwest Oncology LLC

Dyer, Indiana, United States

Northwest Cancer Center - Hobart

Hobart, Indiana, United States

Saint Mary Medical Center

Hobart, Indiana, United States

The Community Hospital

Munster, Indiana, United States

Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Beverly Hospital

Beverly, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Addison Gilbert Hospital

Gloucester, Massachusetts, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Henry Ford Wyandotte Hospital

Wyandotte, Michigan, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Renown Regional Medical Center

Reno, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Wilmot Cancer Institute at Webster

Webster, New York, United States

East Carolina University

Greenville, North Carolina, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Miami Valley Hospital South

Centerville, Ohio, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Premier Blood and Cancer Center

Dayton, Ohio, United States

Miami Valley Hospital North

Dayton, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, United States

Upper Valley Medical Center

Troy, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 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

Oregon Health and Science University

Portland, Oregon, United States

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 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

The West Clinic - Wolf River

Germantown, Tennessee, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

FHCC at EvergreenHealth

Kirkland, Washington, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Legacy Cancer Institute Medical Oncology and Day Treatment

Vancouver, Washington, United States

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Clinical Research Directory

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (100)