Nonoperative management protocol for locally advanced rectal cancer

• Published in: Colorectal disease Vol. 26; no. 6; pp. 1285 - 1291
• Main Authors: Kennedy, Erin D., Schmocker, Selina, Brown, Carl, Liberman, Sender, Baxter, Nancy N., Drolet, Sebastien, Neumann, Katerina, Simunovic, Marko, Richard, Carole, Brezden‐Masley, Christine, Jhaveri, Kartik, Kopek, Neil, Kirsch, Richard
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.06.2024
• Subjects: active surveillance; Adult; Aged; Canada; Cancer; Chemoradiotherapy; Chemoradiotherapy - methods; Colorectal cancer; complete clinical response; Disease management; Disease-Free Survival; Endoscopy; Female; Humans; Ileostomy; Male; Middle Aged; Morbidity; Neoadjuvant Therapy - methods; Neoplasm Recurrence, Local - therapy; Neoplasm Staging; nonoperative management; Ostomy; Patients; Proctectomy - methods; rectal cancer; Rectal Neoplasms - pathology; Rectal Neoplasms - therapy; Rectum; Surgery; Treatment Outcome; Canada; nonoperative management; complete clinical response; active surveillance; rectal cancer
• ISSN: 1462-8910; 1463-1318; 1463-1318
• DOI: 10.1111/codi.17035

Aim The standard treatment for low rectal cancer is preoperative chemoradiotherapy followed by surgery with low anterior resection with diverting ileostomy or abdominoperineal resection, both of which have significant long‐term effects on bowel and sexual function. Due to the high morbidity of surgery, there has been increasing interest in nonoperative management for low rectal cancer. The aim of this work is to conduct a pan‐Canadian Phase II trial assessing the safety of nonoperative management for low rectal cancer. Method Patients with Stage II or III low rectal cancer completing chemoradiotherapy according to standard of care at participating centres will be assessed for complete clinical response 8–14 weeks following completion of chemoradiotherapy. Subjects achieving a clinical complete response will undergo active surveillance including endoscopy, imaging and bloodwork at regular intervals for 24 months. The primary outcome will be the rate of local regrowth 2 years after chemoradiotherapy. Nonoperative management will be considered safe (i.e. as effective as surgery to achieve local control) if the rate of local regrowth is ≤30% and surgical salvage is possible for all local regrowths. Secondary outcomes will include disease‐free and overall survival. Conclusion The results will be highly clinically relevant, as it is expected that nonoperative management will be safe and lead to widespread adoption of nonoperative management in Canada. This change in practice has the potential to decrease the number of patients requiring surgery and the costs associated with surgery and long‐term surgical morbidity.