Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00002575
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
- 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 4/30/99)
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 810
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall survival Up to 8 years Disease-free survival Up to 8 years * 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 4/30/99)
- Secondary Outcome Measures
Name Time Method Morbidity Up to 8 years Mortality At 30 days Costs and cost effectiveness between these treatments in this patient population Up to 8 years Compare the differences in quality of life of patients treated with these regimens Up to 8 years
Trial Locations
- Locations (158)
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
St. Mary's Hospital
🇺🇸Rogers, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Saint Mary Medical Center - Long Beach
🇺🇸Long Beach, California, United States
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