Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007930
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
2001-01-06
Brief Title:
Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
Sponsor:
National Medical Research Council NMRC Singapore
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-99019 | None | None | None |
| NMRC-ICR01 | None | None | None |