Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002575
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
1999-11-01
Brief Title:
Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
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 Less invasive types of surgery may help reduce the number of side effects and improve recovery It is not yet known which type of surgery is more effective for colon cancer
PURPOSE Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer
PURPOSE Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer
Detailed Description:
OBJECTIVES
Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy
Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients
Compare the differences in costs and cost effectiveness between these treatments in this patient population
Compare the differences in quality of life of patients treated with these regimens closed as of 43099
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center primary surgeon site of primary tumor right vs left vs sigmoid and American Society of Anesthesiologists disease classification I and II vs III Patients are randomized to one of two treatment arms
The extent of colon resection is identical for both arms
Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy
Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients
Compare the differences in costs and cost effectiveness between these treatments in this patient population
Compare the differences in quality of life of patients treated with these regimens closed as of 43099
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center primary surgeon site of primary tumor right vs left vs sigmoid and American Society of Anesthesiologists disease classification I and II vs III Patients are randomized to one of two treatment arms
The extent of colon resection is identical for both arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000063648 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02234 | REGISTRY | None | None |
| CAN-NCIC-CO12 | None | None | None |