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 macroscopicall
| Condition(s) | Rectal Neoplasms |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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%. |
| Who can participate | 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 completion of CRT * 18 years or older * Provides written consent Exclusion Criteria: * Unable to undergo MRI * Metastatic disease (including extramesorectal and retroperitoneal lymph nodes) * Pregnancy * Inflammatory bowel disease * More than one primary colorectal cancer * Other malignancy within 5 years of treatment for current rectal cancer * Unfit for surgery |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Mount Sinai Hospital, Canada |
| Locations | Toronto, Ontario, Canada |
| Start date | 2018-03-16 |
| NCT ID | NCT03179540 |
| Official listing | https://clinicaltrials.gov/study/NCT03179540 |