Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
Recruitment status was Active, not recruiting
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.
Procedure: conventional surgery
Procedure: laparoscopic surgery
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER|
|Study Start Date:||August 1994|
- 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.
- Arm I: Patients undergo open laparotomy and colectomy. A standard incision is made through the abdominal wall and the abdominal cavity is explored. A right or left colectomy or a sigmoid resection is performed.
- Arm II: Patients undergo a laparoscopic-assisted colectomy. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with CO2 to allow access and visualization. The abdominal cavity is explored. If advanced local disease is identified, a celiotomy and colectomy are performed. Otherwise, a right or left colectomy or sigmoid resection is performed using laparoscopic-assisted techniques.
Patients may be entered on adjuvant chemotherapy trials after surgery provided the subsequent trial does not include radiotherapy and allows entry of patients from both arms.
Quality of life is assessed at baseline and on days 2 and 14 after surgery, at 2 months, and then at 18 months. (closed as of 4/30/99)
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 810 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002575
Show 158 Study Locations
|Study Chair:||Heidi Nelson, MD||Mayo Clinic|
|Study Chair:||Robert W. Beart, MD||University of Southern California|
|Study Chair:||Mark S. Talamonti, MD||Robert H. Lurie Cancer Center|
|Study Chair:||John M. Skibber, MD||M.D. Anderson Cancer Center|
|Study Chair:||Jane C. Weeks, MD||Dana-Farber Cancer Institute|
|Study Chair:||Hartley S. Stern, MD||Ottawa Regional Cancer Centre|
|Study Chair:||Thomas B. Julian, MD||Allegheny Cancer Center at Allegheny General Hospital|