NCT03179540Recruiting
Non-operative Management for Locally Advanced Rectal Cancer
Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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%.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 12 May 2017
- Start date
- 16 Mar 2018
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Mount Sinai Hospital, Canada
- Diseases
- Colorectal cancer
- NCT number
- NCT03179540
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 16 Mar 2018 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unfit for surgery
Other illness
- Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)
- Inflammatory bowel disease
- More than one primary colorectal cancer
- Other malignancy within 5 years of treatment for current rectal cancer
Other
- Unable to undergo MRI
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sinai Health System Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.