RecruitingNot ApplicableNCT03179540

Non-operative Management for Locally Advanced Rectal Cancer

Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer


Sponsor

Mount Sinai Hospital, Canada

Enrollment

90 participants

Start Date

Mar 16, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR) following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when surgery is required due to local re-growth. NOM will be considered safe or as effective as surgery to achieve local control if the rate of local re-growth is equal to or less than 30% and the rate of a macroscopically positive margin is 0%.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether some patients with advanced rectal cancer (cancer of the lower bowel) who have an excellent response to chemoradiation therapy can avoid major surgery — including permanent colostomy (a bag worn outside the body) — by being closely monitored instead. **You may be eligible if...** - You have stage II or III rectal cancer and have completed standard chemoradiation treatment - You were originally planned for surgery that would likely result in a permanent colostomy - Your cancer shows a complete response (no visible tumor) on examination 8–10 weeks after finishing radiation - You are 18 years or older and able to sign a consent form - You are able to have MRI scans **You may NOT be eligible if...** - You cannot have MRI scans - Your cancer has spread to other parts of the body - You are pregnant - You have inflammatory bowel disease - You have another active cancer within the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENon-operative management

Patients who are eligible and provide informed consent to participate in the trial will undergo non-operative management (i.e., active surveillance for 24 months) according to the schedule outlined in the study protocol.


Locations(1)

Sinai Health System

Toronto, Ontario, Canada

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NCT03179540


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