Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
Recruitment status was Recruiting
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.
Procedure: conventional surgery
Procedure: laparoscopic surgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer|
- Local recurrence at 3 years [ Designated as safety issue: No ]
- Disease-free and overall survival at 5 years [ Designated as safety issue: No ]
|Study Start Date:||August 1999|
- 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.
|Hong Kong Sanatorium & Hospital||Recruiting|
|Hong Kong, China|
|Contact: Samuel P.Y. Kwok, MD 852-2899-2217 firstname.lastname@example.org|
|Pamela Youde Nethersole Eastern Hospital||Recruiting|
|Hong Kong, China|
|Contact: Michael K.W. Li, FRCS, FHKAM 852-2595-6389 email@example.com|
|National Cancer Centre - Singapore||Recruiting|
|Singapore, Singapore, 169608|
|Contact: Heah Sieu Min, MD 65-6526-5247|
|Study Chair:||Heah Sieu Min, MD||National Cancer Centre, Singapore|