Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT00007930|
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : January 27, 2003
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: conventional surgery Procedure: laparoscopic surgery||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Official Title:||Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer|
|Study Start Date :||August 1999|
- Local recurrence at 3 years
- Disease-free and overall survival at 5 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007930
|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|