Non-surgical treatment for low rectal cancer after chemotherapy and radiation
Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer
This study is testing if patients with low rectal cancer who respond well to chemotherapy and radiation can safely avoid surgery by being closely monitored instead.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03179540 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of non-operative management (NOM) for patients with low rectal cancer who achieve a complete clinical response after chemoradiotherapy. It aims to determine if NOM can effectively replace surgery by monitoring local re-growth rates and the presence of positive resection margins when surgery is necessary. The study will involve active surveillance of patients instead of immediate surgical intervention, potentially reducing the long-term complications associated with surgery. Conducted across multiple centers in Canada, this Phase II trial seeks to provide more robust evidence for the NOM approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with low rectal cancer who have completed chemoradiotherapy and achieved a complete clinical response.
Not a fit: Patients with metastatic disease, inflammatory bowel disease, or those unfit for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for surgery and its associated complications for patients with low rectal cancer.
How similar studies have performed: While there have been a few single institution studies showing favorable results with non-operative management, this approach has not yet been widely adopted, making this study a significant step in evaluating its safety.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Toronto, Ontario
- Sinai Health System — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Erin Kennedy — Sinai Health System
- Study coordinator: Erin Kennedy
- Email: erin.kennedy@sinaihealthsystem.ca
- Phone: 416-586-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.