Non-operative Management for Locally Advanced Rectal Cancer

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%.

Trial Details

NCT ID
NCT03179540
Phase
NA
Sponsor
Mount Sinai Hospital, Canada
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Non-operative management
Locations (sample)
  • Toronto, Ontario, Canada|43.70643,-79.39864

Key Eligibility 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 ca…
  • Planned or probable APR
  • ALL criteria for complete clinical response are met between 8 and 10 weeks following completion of CRT
  • 18 years or older

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →