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?
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Clinical response rate upon re-staging — 6 years
Quality of Life defined using the LARS score — 6 years
Trial sites (113)
Facility
City
Region
Status
Cancer Center at Saint Joseph's
Phoenix
Arizona
Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine
California
Recruiting
Los Angeles General Medical Center
Los Angeles
California
Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles
California
Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
California
Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria
California
Recruiting
Beebe South Coastal Health Campus
Millville
Delaware
Recruiting
Helen F Graham Cancer Center
Newark
Delaware
Recruiting
Medical Oncology Hematology Consultants PA
Newark
Delaware
Recruiting
Beebe Health Campus
Rehoboth Beach
Delaware
Recruiting
Orlando Health Cancer Institute
Orlando
Florida
Suspended
Emory University Hospital Midtown
Atlanta
Georgia
Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta
Georgia
Recruiting
Emory Saint Joseph's Hospital
Atlanta
Georgia
Recruiting
Rush-Copley Medical Center
Aurora
Illinois
Recruiting
Northwestern University
Chicago
Illinois
Recruiting
Carle at The Riverfront
Danville
Illinois
Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb
Illinois
Recruiting
Carle Physician Group-Effingham
Effingham
Illinois
Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva
Illinois
Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon
Illinois
Recruiting
Carle Cancer Center
Urbana
Illinois
Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville
Illinois
Recruiting
Northwest Cancer Center - Crown Point
Crown Point
Indiana
Recruiting
Northwest Oncology LLC
Dyer
Indiana
Recruiting
Northwest Cancer Center - Hobart
Hobart
Indiana
Recruiting
Saint Mary Medical Center
Hobart
Indiana
Recruiting
The Community Hospital
Munster
Indiana
Recruiting
Northwest Cancer Center - Valparaiso
Valparaiso
Indiana
Recruiting
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington
Louisiana
Recruiting
University Medical Center New Orleans
New Orleans
Louisiana
Recruiting
Ochsner Medical Center Jefferson
New Orleans
Louisiana
Recruiting
Beverly Hospital
Beverly
Massachusetts
Recruiting
Lahey Clinic
Burlington
Massachusetts
Recruiting
Addison Gilbert Hospital
Gloucester
Massachusetts
Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown
Michigan
Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township
Michigan
Recruiting
Henry Ford Medical Center-Fairlane
Dearborn
Michigan
Recruiting
Henry Ford Hospital
Detroit
Michigan
Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids
Michigan
Recruiting
+ 73 more sites — see the full list on the official registry below.
More Canadian Cancer Trials Group trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.