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Could early rectal cancer patients skip radiation? new trial aims to find out

NCT ID NCT06205485

Disease control Sponsor: Canadian Cancer Trials Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests whether giving chemotherapy alone before limited surgery works as well as chemotherapy plus radiation for early rectal cancer. The goal is to see if avoiding radiation improves quality of life without harming cancer control. About 250 adults with early-stage rectal cancer will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    113 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addison Gilbert Hospital

    RECRUITING

    Gloucester, Massachusetts, 01930, United States

  • Allan Blair Cancer Centre

    RECRUITING

    Regina, Saskatchewan, S4T 7T1, Canada

  • Allegiance Health

    RECRUITING

    Jackson, Michigan, 49201, United States

    Contact Email: •••••@•••••

  • Atrium Medical Center-Middletown Regional Hospital

    RECRUITING

    Franklin, Ohio, 45005-1066, United States

    Contact Email: •••••@•••••

  • BCCA-Vancouver Cancer Centre

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Beebe Health Campus

    RECRUITING

    Rehoboth Beach, Delaware, 19971, United States

    Contact Email: •••••@•••••

  • Beebe South Coastal Health Campus

    RECRUITING

    Millville, Delaware, 19967, United States

    Contact Email: •••••@•••••

  • Beverly Hospital

    RECRUITING

    Beverly, Massachusetts, 01915, United States

  • CIUSSSEMTL-Hopital Maisonneuve-Rosemont

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Cancer Center at Saint Joseph's

    RECRUITING

    Phoenix, Arizona, 85004, United States

    Contact Email: •••••@•••••

  • CancerCare Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • Christiana Care Health System-Concord Health Center

    RECRUITING

    Chadds Ford, Pennsylvania, 19317, United States

  • Clackamas Radiation Oncology Center

    RECRUITING

    Clackamas, Oregon, 97015, United States

    Contact Email: •••••@•••••

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dartmouth Cancer Center - North

    RECRUITING

    Saint Johnsbury, Vermont, 05819, United States

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Doctor H. Bliss Murphy Cancer Centre

    RECRUITING

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

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Emory Saint Joseph's Hospital

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • FHCC Overlake

    RECRUITING

    Bellevue, Washington, 98004, United States

  • FHCC at EvergreenHealth

    RECRUITING

    Kirkland, Washington, 98034, United States

  • FHCC at Northwest Hospital

    RECRUITING

    Seattle, Washington, 98133, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Helen F Graham Cancer Center

    RECRUITING

    Newark, Delaware, 19713, United States

  • Henry Ford Cancer Institute-Downriver

    RECRUITING

    Brownstown, Michigan, 48183, United States

    Contact Email: •••••@•••••

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • Henry Ford Macomb Hospital-Clinton Township

    RECRUITING

    Clinton Township, Michigan, 48038, United States

    Contact Email: •••••@•••••

  • Henry Ford Medical Center-Columbus

    RECRUITING

    Novi, Michigan, 48377, United States

    Contact Email: •••••@•••••

  • Henry Ford Medical Center-Fairlane

    RECRUITING

    Dearborn, Michigan, 48126, United States

    Contact Email: •••••@•••••

  • Henry Ford West Bloomfield Hospital

    RECRUITING

    West Bloomfield, Michigan, 48322, United States

    Contact Email: •••••@•••••

  • Henry Ford Wyandotte Hospital

    RECRUITING

    Wyandotte, Michigan, 48192, United States

  • Lahey Clinic

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Legacy Cancer Institute Medical Oncology and Day Treatment

    RECRUITING

    Vancouver, Washington, 98684, United States

    Contact Email: •••••@•••••

  • Legacy Good Samaritan Hospital and Medical Center

    RECRUITING

    Portland, Oregon, 97210, United States

    Contact Email: •••••@•••••

  • Legacy Meridian Park Hospital

    RECRUITING

    Tualatin, Oregon, 97062, United States

  • Legacy Mount Hood Medical Center

    RECRUITING

    Gresham, Oregon, 97030, United States

  • Legacy Salmon Creek Hospital

    RECRUITING

    Vancouver, Washington, 98686, United States

  • London Regional Cancer Program

    RECRUITING

    London, Ontario, N6A 4L6, Canada

  • Los Angeles General Medical Center

    RECRUITING

    Los Angeles, California, 90033, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center - Minocqua

    RECRUITING

    Minocqua, Wisconsin, 54548, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center - Weston

    RECRUITING

    Weston, Wisconsin, 54476, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-EC Cancer Center

    RECRUITING

    Eau Claire, Wisconsin, 54701, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Marshfield

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Rice Lake

    RECRUITING

    Rice Lake, Wisconsin, 54868, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-River Region at Stevens Point

    RECRUITING

    Stevens Point, Wisconsin, 54482, United States

    Contact Email: •••••@•••••

  • Medical Oncology Hematology Consultants PA

    RECRUITING

    Newark, Delaware, 19713, United States

  • Memorial Sloan Kettering Basking Ridge

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    RECRUITING

    Harrison, New York, 10604, United States

  • Mercy Hospital Saint Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Miami Valley Cancer Care and Infusion

    RECRUITING

    Greenville, Ohio, 45331, United States

  • Miami Valley Hospital

    SUSPENDED

    Dayton, Ohio, 45409, United States

  • Miami Valley Hospital North

    RECRUITING

    Dayton, Ohio, 45415, United States

    Contact Email: •••••@•••••

  • Miami Valley Hospital South

    RECRUITING

    Centerville, Ohio, 45459, United States

    Contact Email: •••••@•••••

  • Mission Hope Medical Oncology - Santa Maria

    RECRUITING

    Santa Maria, California, 93444, United States

    Contact Email: •••••@•••••

  • Northwest Cancer Center - Crown Point

    RECRUITING

    Crown Point, Indiana, 46307, United States

    Contact Email: •••••@•••••

  • Northwest Cancer Center - Hobart

    RECRUITING

    Hobart, Indiana, 46342, United States

  • Northwest Cancer Center - Valparaiso

    RECRUITING

    Valparaiso, Indiana, 46383, United States

    Contact Email: •••••@•••••

  • Northwest Oncology LLC

    RECRUITING

    Dyer, Indiana, 46311, United States

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

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

    RECRUITING

    Covington, Louisiana, 70433, United States

  • Ochsner Medical Center Jefferson

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Orlando Health Cancer Institute

    SUSPENDED

    Orlando, Florida, 32806, United States

  • Ottawa Hospital and Cancer Center-General Campus

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Penn State Milton S Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033-0850, United States

  • Premier Blood and Cancer Center

    RECRUITING

    Dayton, Ohio, 45409, United States

  • Providence Newberg Medical Center

    RECRUITING

    Newberg, Oregon, 97132, United States

    Contact Email: •••••@•••••

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Providence Saint Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

    Contact Email: •••••@•••••

  • Providence Willamette Falls Medical Center

    RECRUITING

    Oregon City, Oregon, 97045, United States

    Contact Email: •••••@•••••

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

    Contact Email: •••••@•••••

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Rush-Copley Medical Center

    RECRUITING

    Aurora, Illinois, 60504, United States

  • Saint Mary Medical Center

    RECRUITING

    Hobart, Indiana, 46342, United States

    Contact Email: •••••@•••••

  • Sanford Bismarck Medical Center

    RECRUITING

    Bismarck, North Dakota, 58501, United States

    Contact Email: •••••@•••••

  • Sanford Broadway Medical Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford Cancer Center Oncology Clinic

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

    Contact Email: •••••@•••••

  • Sanford Joe Lueken Cancer Center

    RECRUITING

    Bemidji, Minnesota, 56601, United States

    Contact Email: •••••@•••••

  • Sanford Roger Maris Cancer Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford USD Medical Center - Sioux Falls

    RECRUITING

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

    Contact Email: •••••@•••••

  • Saskatoon Cancer Centre

    RECRUITING

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Scott and White Memorial Hospital

    RECRUITING

    Temple, Texas, 76508, United States

  • The Community Hospital

    RECRUITING

    Munster, Indiana, 46321, United States

  • The West Clinic - Wolf River

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

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

    RECRUITING

    Irvine, California, 92612, United States

    Contact Email: •••••@•••••

  • USC / Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University Medical Center New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

    Contact Email: •••••@•••••

  • University of Cincinnati Cancer Center-West Chester

    RECRUITING

    West Chester, Ohio, 45069, United States

    Contact Email: •••••@•••••

  • University of New Mexico Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • Upper Valley Medical Center

    RECRUITING

    Troy, Ohio, 45373, United States

    Contact Email: •••••@•••••

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Mason Medical Center

    RECRUITING

    Seattle, Washington, 98101, United States

    Contact Email: •••••@•••••

  • West Michigan Cancer Center

    RECRUITING

    Kalamazoo, Michigan, 49007, United States

  • Wilmot Cancer Institute at Webster

    RECRUITING

    Webster, New York, 14580, United States

    Contact Email: •••••@•••••

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