Non-operative Management for Locally Advanced Rectal Cancer

Recruiting now · Not applicable

Conditions studied: Rectal Neoplasms

In brief

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%.

Key facts

Study ID

NCT03179540

Run by

Mount Sinai Hospital, Canada

People needed

90

Starts

2018-03-16

Expected to finish

2028-12-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Sinai Health System — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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