Nonoperative management protocol for locally advanced rectal cancer

Area of Science:

• Oncology
• Surgical Oncology
• Gastroenterology

Background:

• Standard treatment for low rectal cancer involves chemoradiotherapy followed by surgery, often resulting in significant long-term bowel and sexual dysfunction.
• High surgical morbidity has spurred interest in nonoperative management (NOM) strategies for low rectal cancer.

Purpose of the Study:

• To conduct a pan-Canadian Phase II trial assessing the safety and efficacy of nonoperative management for low rectal cancer.
• To evaluate the potential of NOM to reduce surgical complications and improve patient outcomes.

Main Methods:

• Patients with Stage II or III low rectal cancer who completed chemoradiotherapy were assessed for clinical complete response (cCR).
• Subjects achieving cCR underwent active surveillance (endoscopy, imaging, bloodwork) for 24 months.
• The primary outcome was the rate of local regrowth at 2 years, with safety defined by a regrowth rate ≤30% and successful surgical salvage.

Main Results:

• The study is ongoing; results are pending.
• The primary outcome will determine if nonoperative management is as effective as surgery for local control.

Conclusions:

• Nonoperative management is anticipated to be safe and effective, potentially leading to widespread adoption in Canada.
• Successful implementation of NOM could decrease the number of patients requiring surgery, thereby reducing associated costs and long-term morbidity.