Actively Recruiting
Non-operative Management for Locally Advanced Rectal Cancer
Led by Mount Sinai Hospital, Canada · Updated on 2024-11-20
90
Participants Needed
1
Research Sites
454 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%.
CONDITIONS
Official Title
Non-operative Management for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed chemoradiotherapy as standard care for Stage II or III low rectal cancer
- Planned or probable abdominoperineal resection (APR) surgery
- Achieved complete clinical response 8 to 10 weeks after finishing chemoradiotherapy
- At least 18 years old
- Provided written informed consent
You will not qualify if you...
- Unable to undergo MRI scans
- Presence of metastatic disease including extramesorectal and retroperitoneal lymph nodes
- Pregnant
- Have inflammatory bowel disease
- Have more than one primary colorectal cancer
- Had another malignancy within 5 years before current rectal cancer treatment
- Not fit for surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sinai Health System
Toronto, Ontario, Canada, M5T 3L9
Actively Recruiting
Research Team
E
Erin Kennedy
CONTACT
S
Selina Schmocker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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