Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Procedure: conventional surgeryProcedure: laparoscopic surgery
- 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
- Arm && Interventions
Group Intervention Description Conventional surgery conventional surgery 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. 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. Laparoscopic-assisted colectomy laparoscopic surgery 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.
- 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 Compare the differences in quality of life of patients treated with these regimens Up to 8 years Morbidity Up to 8 years Mortality At 30 days Costs and cost effectiveness between these treatments in this patient population Up to 8 years
Trial Locations
- Locations (158)
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Regional Cancer Center
🇺🇸Indianapolis, Indiana, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Jewish Hospital of Cincinnati, Inc.
🇺🇸Cincinnati, Ohio, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
St. Louis University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Saint Mary Medical Center - Long Beach
🇺🇸Long Beach, 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
Naval Medical Center - Oakland
🇺🇸Oakland, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Baptist Regional Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Medical College of Georgia Comprehensive Cancer Center
🇺🇸Augusta, Georgia, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
MBCCOP-Cook County Hospital
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Illinois Masonic Medical Center
🇺🇸Chicago, Illinois, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
West Suburban Hospital Medical Center
🇺🇸Oak Park, Illinois, United States
Rockford Clinic
🇺🇸Rockford, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Regional Cancer Therapy Center - Frederick
🇺🇸Frederick, Maryland, United States
Berkshire Medical Center
🇺🇸Pittsfield, Massachusetts, United States
Lahey Clinic - Burlington
🇺🇸Burlington, Massachusetts, United States
University of Massachusetts Memorial Healthcare
🇺🇸Worester, Massachusetts, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Royal Victoria Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Jewish General Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
St. Mary's Hospital
🇺🇸Rogers, Arkansas, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Methodist Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
University of New Mexico Cancer Research & Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Albany Regional Cancer Center
🇺🇸Albany, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Champlain Valley Physicians Hospital Medical Center
🇺🇸Plattsburgh, New York, United States
Genesee Surgical Associates
🇺🇸Rochester, New York, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Aultman Cancer Center
🇺🇸Canton, Ohio, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
South Pointe Hospital
🇺🇸Cleveland, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
Oregon Cancer Center
🇺🇸Portland, Oregon, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
St. Luke's Network - Bethlehem
🇺🇸Bethlehem, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Kent County Memorial Hospital
🇺🇸Warwick, Rhode Island, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Baptist Regional Cancer Center - Knoxville
🇺🇸Knoxville, Tennessee, United States
Medical Group of Texas
🇺🇸Dallas, Texas, United States
Kelsey Seybold Clinic
🇺🇸Houston, Texas, United States
Wilford Hall - 59th Medical Wing
🇺🇸Lackland Air Force Base, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Texas Health Center at Tyler
🇺🇸Tyler, Texas, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Virginia Oncology Associates - Newport News
🇺🇸Newport News, Virginia, United States
Puget Sound Oncology Consortium
🇺🇸Seattle, Washington, United States
Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
CCOP - Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
🇨🇦Toronto, Ontario, Canada
National Naval Medical Center
🇺🇸Bethesda, Maryland, United States
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
L'Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
MBCCOP - San Juan
🇵🇷San Juan, Puerto Rico
Veterans Affairs Medical Center - San Juan
🇵🇷San Juan, Puerto Rico
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Veterans Affairs Satellite Clinic - Sacramento
🇺🇸Sacramento, California, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Norton Healthcare System
🇺🇸Louisville, Kentucky, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Louisiana State University Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Richmond
🇺🇸Richmond, Virginia, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Lucille Parker Markey Cancer Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States