Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer
NCT ID: NCT06205485
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2024-06-26
2030-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy, followed by surgery. There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy. For patients who get the usual approach for this cancer, about 90 out of 100 are free of cancer after 5 years.
If a patient decides to take part in this study, they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks.
After finishing treatment, and even if treatment is stopped early, the study doctor will watch for side effects and determine which type of surgery would be best. After surgery, patients will be asked to come in every 4 months for 2 years, then every 6 months for an additional year. Then will be checked every year for 2 years. This means seeing the study doctor for up to 5 years after surgery. Patients may be seen more often if your study doctor thinks it is necessary.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
ChemoRT
Standard dose of infusional 5-Fluorouracil/capecitabine and radiation
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* MRI stage cT1 not eligible for transanal surgery or cT2-T3a.
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alliance for Clinical Trials in Oncology
OTHER
ECOG-ACRIN Cancer Research Group
NETWORK
NRG Oncology
OTHER
SWOG Cancer Research Network
NETWORK
Canadian Cancer Trials Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hagen Kennecke
Role: STUDY_CHAIR
Providence Portland Medical Centre, Portland, OR, USA
Carl Brown
Role: STUDY_CHAIR
St. Paul's Hospital, Vancouver, BC, Canada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, 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
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
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
Virginia Mason Medical 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCTG-CO32
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2023-10515
Identifier Type: OTHER
Identifier Source: secondary_id
CCTG-CO32
Identifier Type: -
Identifier Source: org_study_id