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Non-operative Management for Locally Advanced Rectal Cancer
Sponsor: Mount Sinai Hospital, Canada
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%.
Official title: Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2018-03-16
Completion Date
2026-12
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
Non-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