Non-operative Management for Locally Advanced Rectal Cancer
Recruiting
N/A
Interventional Study
Rectal Neoplasms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Mount Sinai Hospital, Canada · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Completed chemoradiotherapy (CRT) as standard of care \[Stage II and Stage III (T3-T4N0, AnyTN1-2)\]; \[50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine\]
* Planned or probable APR
* ALL criteria for complete clinical response are met between 8 and 10 weeks following comp…
Contacts