NCT03179540 Non-operative Management for Locally Advanced Rectal Cancer
| NCT ID | NCT03179540 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mount Sinai Hospital, Canada |
| Condition | Rectal Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2018-03-16 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2018-03-16 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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%.
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 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
Contact & Investigator
Erin Kennedy
PRINCIPAL INVESTIGATOR
Sinai Health System
Frequently Asked Questions
Who can join the NCT03179540 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03179540 currently recruiting?
Yes, NCT03179540 is actively recruiting participants. Contact the research team at erin.kennedy@sinaihealthsystem.ca for enrollment information.
Where is the NCT03179540 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT03179540 clinical trial?
NCT03179540 is sponsored by Mount Sinai Hospital, Canada. The principal investigator is Erin Kennedy at Sinai Health System. The trial plans to enroll 90 participants.