NCT03548844

Local Excision Versus Total Mesorectal Excision In Pathological Complete Response (ypT0-1cN0) Mid- Or Low-Rectal Cancer After Neoadjuvant Therapy

A Prospective Randomized Controlled Trial Of Local Excision Versus Total Mesorectal Excision In Pathological Complete Response (ypT0-1cN0) Mid- or Low-Rectal Cancer After Neoadjuvant Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 326 (estimated)
• Sponsor: Yanhong Deng · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with cT2-4aN0-2M0 mid- or low-rectal cancer received neoadjuvant chemotherapy or combined chemoradiotherapy. Good responders (cT0-1N0) patients received local excision 4-8 weeks after treatment. Pathologically verified ypT0-1 patients are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). The composite end points include 3 year disease-free survival (DFS), overall survival (OS), recurrence, major morbidity and quality of life.

Detailed description

Total mesorectal excision is still the standard surgical treatment of mid-and low advanced rectal cancer after neoadjuvant treatment. This radical procedure inevitably has the risk of major short and long term morbidity and anorectal function impairment. Additionally, abdominal perineal resection(APR) with permanent stoma is still applied to some low rectal cancer patients, even though major response had been achieved after neoadjuvant treatment. Previous studies have proposed "wait and see" strategy in clinical complete response patients. The local recurrence rate is still high due to residue adenocarcinoma lesion. Local excision is a conservative alternative approach associated with low mortality and morbidity and high quality of life. In this study, the investigators proposed local excision in good responders (cT0-1N0) 4-8 weeks after neoadjuvant treatment. Patients with pathologically verified complete response (ypT0-1cN0) are randomized to observation (local excision group) or complementary rectal excision (total mesorectal excision group). The purpose of this prospective randomized controlled study is to compare local excision versus total mesorectal excision in pathological complete response (ypT0-1cN0) mid- or low-rectal cancer after neoadjuvant therapy.

Conditions

• Rectal Cancer
• Surgery

Interventions

Type	Name	Description
PROCEDURE	local excision	Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to observation (local excision group) .
PROCEDURE	total mesorectal excision	Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to complementary rectal excision (total mesorectal excision group).

Timeline

• Start date: 2018-05-24
• Primary completion: 2021-05-01
• Completion: 2023-05-01
• First posted: 2018-06-07
• Last updated: 2018-06-07

Locations

1 site across 1 country: China