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Non-operative Management for Locally Advanced Rectal Cancer

Rectal Neoplasms

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%.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

Sinai Health System
Sinai Health System
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Erin Kennedy

Study Sponsored By
Mount Sinai Hospital, Canada
Participants Required
More Information
Study ID: NCT03179540