A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
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.
OBJECTIVES:
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.
DISEASE CHARACTERISTICS:
Clinical diagnosis of primary adenocarcinoma
Involving a single colon segment:
Diagnosis based on physical exam plus either a proctosigmoidoscopy and barium enema or a colonoscopy
No advanced local disease that renders laparoscopic resection impossible
No acutely obstructed or perforated colon cancer requiring urgent surgery
No transverse colon cancer (i.e., between distal hepatic flexure and proximal splenic flexure)
No stage IV disease
No rectal cancer (i.e., below the peritoneal reflection, lower edge of tumor less than 15 cm from dentate)
No American Society of Anesthesiologists IV/V disease classification
No associated gastrointestinal diseases (i.e., Crohn's, chronic ulcerative colitis, or familial polyposis) that require additional extensive operative evaluation or intervention
PATIENT CHARACTERISTICS:
Age:
Other:
PRIOR CONCURRENT THERAPY:
Surgery:
Other:
Duarte, California 91010-3000, United States
Chicago, Illinois 60611-3013, United States
Lexington, Kentucky 40536-0093, United States
Worester, Massachusetts 01605, United States
Albuquerque, New Mexico 87131, United States
Syracuse, New York 13217, United States
Winston-Salem, North Carolina 27157-1082, United States
San Antonio, Texas 78284-7811, United States
Roanoke, Virginia 24014, United States
Marshfield, Wisconsin 54449, United States
Ste-Foy, Quebec G1V 4G5, Canada