Non-operative Management for Locally Advanced Rectal Cancer

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

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

Conditions2

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