Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer

Phase 3

• Conditions: Colorectal Cancer

• Registration Number: NCT00007930
• Lead Sponsor: National Medical Research Council (NMRC), Singapore

Brief Summary

RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.

Detailed Description

OBJECTIVES:

* Compare local and distant recurrences in patients with mid-rectal cancer treated with wide mesorectal surgical excision with straight colorectal anastomosis versus total mesorectal surgical excision with colonic J pouch coloanal anastomosis.

* Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures.

* Compare disease-free survival and overall survival in these patients treated with these two surgical procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo surgical resection with a wide mesorectal excision followed by a straight colorectal anastomosis.

* Arm II: Patients undergo surgical resection with a total mesorectal excision followed by a colonic J pouch coloanal anastomosis. Patients then receive a temporary ileostomy which is closed 6 weeks later.

Patients are followed at 6 weeks, every 4-6 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 800 patients (400 per arm) will be accrued for this study.

Study Timeline

• Study Start: 1999-08
• Study First Submitted: 2001-01-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2006-12
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local recurrence at 3 years

Secondary Outcome Measures

Name	Time	Method
Disease-free and overall survival at 5 years

Trial Locations

Locations (3)

National Cancer Centre - Singapore; 🇸🇬 Singapore, Singapore

Hong Kong Sanatorium & Hospital; 🇨🇳 Hong Kong, China

Pamela Youde Nethersole Eastern Hospital; 🇨🇳 Hong Kong, China