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.

Condition	Treatment or Intervention	Phase
stage III colon cancer stage I colon cancer adenocarcinoma of the colon stage II colon cancer	Procedure: surgery  Procedure: laparoscopic surgery  Procedure: conventional surgery	Phase III

Further Study Details: 

OBJECTIVES: I. Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy. II. Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients. III. Compare the differences in costs and cost effectiveness between these treatments in this patient population. IV. Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)

PROTOCOL 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 900 patients will be accrued for this study within 3 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Clinical diagnosis of primary adenocarcinoma Involving a single colon segment: * Right colon from the ileocecal valve up to and including the hepatic flexure * Left colon from the splenic flexure to the junction of the sigmoid and descending colon * Sigmoid colon between the descending colon and the rectum (at least 15 cm from the dentate)
• 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

--Prior/Concurrent Therapy--

Biologic therapy: Not specified

Chemotherapy: Not specified

Endocrine therapy: Not specified

Radiotherapy: Not specified

Surgery:

• See Disease Characteristics
• No prohibitive scars/adhesions from prior abdominal surgery Other: No concurrent investigational treatments or invasive diagnostic procedures within 30 days after surgery

--Patient Characteristics--

Age: 18 and over

Performance status: Not specified

Hematopoietic: Not specified

Hepatic: Not specified

Renal: Not specified

Other:

• No other prior or concurrent malignancy within the past 5 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Alabama
      Huntsville Hospital System, Huntsville,  Alabama,  35801-4470,  United States
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36688,  United States
Arizona
      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States
Arkansas
      St. Mary's Hospital, Rogers,  Arkansas,  72756,  United States
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States
California
      Cancer Center and Beckman Research Institute, City of Hope, Duarte,  California,  91010-3000,  United States
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States
      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States
      Kaiser Permanente Medical Center - Vallejo, Vallejo,  California,  94589,  United States
      Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States
      Naval Medical Center - Oakland, Oakland,  California,  94627-5000,  United States
      Naval Medical Center - San Diego, San Diego,  California,  92134-3202,  United States
      Saint Mary Medical Center - Long Beach, Long Beach,  California,  90813-0887,  United States
      Scripps Clinic, La Jolla,  California,  92037,  United States
      Sutter Cancer Center, Sacramento,  California,  95816,  United States
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States
      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States
      Veterans Affairs Satellite Clinic - Sacramento, Sacramento,  California,  95820,  United States
Colorado
      CCOP - Colorado Cancer Research Program, Inc., Denver,  Colorado,  80209-5031,  United States
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
Connecticut
      Hartford Hospital, Hartford,  Connecticut,  06102-5037,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
Florida
      Baptist Regional Cancer Institute - Jacksonville, Jacksonville,  Florida,  32207,  United States
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
      MD Anderson Cancer Center Orlando, Orlando,  Florida,  32806,  United States
      Sarasota Memorial Hospital, Sarasota,  Florida,  34239,  United States
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States
      Medical College of Georgia Comprehensive Cancer Center, Augusta,  Georgia,  30912-4000,  United States
      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States
      Winship Cancer Institute, Atlanta,  Georgia,  30322,  United States
Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      Illinois Masonic Medical Center, Chicago,  Illinois,  60657,  United States
      MBCCOP-Cook County Hospital, Chicago,  Illinois,  60612,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States
      Rockford Clinic, Rockford,  Illinois,  61103,  United States
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
      Veterans Affairs Medical Center - Lakeside Chicago, Chicago,  Illinois,  60611,  United States
      West Suburban Hospital Medical Center, Oak Park,  Illinois,  60302,  United States
Indiana
      Regional Cancer Center, Indianapolis,  Indiana,  46219,  United States
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Kentucky
      Baptist Hospital East - Louisville, Louisville,  Kentucky,  40207,  United States
      Lucille Parker Markey Cancer Center, University of Kentucky, Lexington,  Kentucky,  40536-0093,  United States
      Norton Healthcare System, Louisville,  Kentucky,  40202-5070,  United States
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States
      Louisiana State University Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States
      Tulane University School of Medicine, New Orleans,  Louisiana,  70112,  United States
      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States
Maine
      Eastern Maine Medical Center, Bangor,  Maine,  04401,  United States
Maryland
      Franklin Square Hospital Center, Baltimore,  Maryland,  21237,  United States
      National Naval Medical Center, Bethesda,  Maryland,  20889-5000,  United States
      Regional Cancer Therapy Center - Frederick, Frederick,  Maryland,  21701,  United States
Massachusetts
      Baystate Medical Center, Springfield,  Massachusetts,  01199,  United States
      Berkshire Medical Center, Pittsfield,  Massachusetts,  01201,  United States
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States
      Lahey Clinic - Burlington, Burlington,  Massachusetts,  01805,  United States
      New England Medical Center Hospital, Boston,  Massachusetts,  02111,  United States
      University of Massachusetts Memorial Healthcare, Worester,  Massachusetts,  01605,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
      CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids,  Michigan,  49503,  United States
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
      Michigan State University, East Lansing,  Michigan,  48824,  United States
      Providence Hospital - Southfield, Southfield,  Michigan,  48075-9975,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Hennepin County Medical Center - Minneapolis, Minneapolis,  Minnesota,  55415,  United States
Mississippi
      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      St. Louis University School of Medicine, Saint Louis,  Missouri,  63104,  United States
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States
      Methodist Cancer Center - Omaha, Omaha,  Nebraska,  68114,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States
      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112,  United States
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018-1095,  United States
New Mexico
      University of New Mexico Cancer Research & Treatment Center, Albuquerque,  New Mexico,  87131,  United States
New York
      Albany Regional Cancer Center, Albany,  New York,  12208,  United States
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13217,  United States
      Champlain Valley Physicians Hospital Medical Center, Plattsburgh,  New York,  12901,  United States
      Genesee Surgical Associates, Rochester,  New York,  14607,  United States
      Staten Island University Hospital, Staten Island,  New York,  10305,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Veterans Affairs Medical Center - Fargo, Fargo,  North Dakota,  58102,  United States
Ohio
      Akron City Hospital, Akron,  Ohio,  44309,  United States
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States
      Aultman Cancer Center, Canton,  Ohio,  44710,  United States
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45267-0502,  United States
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      CCOP - Dayton, Kettering,  Ohio,  45429,  United States
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
      Jewish Hospital of Cincinnati, Inc., Cincinnati,  Ohio,  45236,  United States
      South Pointe Hospital, Cleveland,  Ohio,  44122,  United States
      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428,  United States
Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States
Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States
      Oregon Cancer Center, Portland,  Oregon,  97201-3098,  United States
Pennsylvania
      Albert Einstein Cancer Center, Philadelphia,  Pennsylvania,  19141,  United States
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States
      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States
      Geisinger Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
      Lehigh Valley Hospital, Allentown,  Pennsylvania,  18103,  United States
      Reading Hospital and Medical Center, Reading,  Pennsylvania,  19612-6052,  United States
      St. Luke's Network - Bethlehem, Bethlehem,  Pennsylvania,  18015,  United States
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213-3489,  United States
      Veterans Affairs Medical Center - Pittsburgh, Pittsburgh,  Pennsylvania,  15240,  United States
      York Hospital, York,  Pennsylvania,  17315,  United States
Rhode Island
      Kent County Memorial Hospital, Warwick,  Rhode Island,  02886,  United States
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
Tennessee
      Baptist Regional Cancer Center - Knoxville, Knoxville,  Tennessee,  37901,  United States
      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States
Texas
      Kelsey Seybold Clinic, Houston,  Texas,  77025,  United States
      Medical Group of Texas, Dallas,  Texas,  75243,  United States
      University of Texas Health Center at Tyler, Tyler,  Texas,  75708,  United States
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States
      Wilford Hall - 59th Medical Wing, Lackland Air Force Base,  Texas,  78236-5300,  United States
Utah
      Utah Valley Regional Medical Center - Provo, Provo,  Utah,  84604,  United States
Vermont
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
Virginia
      Eastern Virginia Medical School, Norfolk,  Virginia,  23507,  United States
      Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
      Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke,  Virginia,  24014,  United States
      Veterans Affairs Medical Center - Richmond, Richmond,  Virginia,  23249,  United States
      Virginia Oncology Associates - Newport News, Newport News,  Virginia,  23606,  United States
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States
      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States
      Puget Sound Oncology Consortium, Seattle,  Washington,  98109,  United States
West Virginia
      Camden-Clark Memorial Hospital, Parkersburg,  West Virginia,  26102,  United States
Wisconsin
      CCOP - Green Bay, Green Bay,  Wisconsin,  54301,  United States
      CCOP - Marshfield Medical Research and Education Foundation, Marshfield,  Wisconsin,  54449,  United States
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada
Canada, Ontario
      St. Michael's Hospital - Toronto, Toronto,  Ontario,  M5B 1W8,  Canada
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada
Canada, Quebec
      Centre Hospitalier de l'Universite de Montreal, Montreal,  Quebec,  H2L-4M1,  Canada
      Centre Hospitalier Universitaire de Quebec, Quebec City,  Quebec,  G1R 2J6,  Canada
      Jewish General Hospital - Montreal, Montreal,  Quebec,  H3T 1E2,  Canada
      L'Hopital Laval, Ste Foy,  Quebec,  G1V 4G5,  Canada
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada
      Royal Victoria Hospital - Montreal, Montreal,  Quebec,  H3A 1A1,  Canada
Puerto Rico
      MBCCOP - San Juan, San Juan,  00927-5800,  Puerto Rico
      Veterans Affairs Medical Center - San Juan, San Juan,  00927-5800,  Puerto Rico

Study chairs or principal investigators

Michael J. O'Connell,  Study Chair,  North Central Cancer Treatment Group   
Charles A. Coltman, Jr.,  Study Chair
Mark S. Talamonti,  Study Chair
Walter John Curran, Jr.,  Study Chair
Richard L. Schilsky,  Study Chair
Hartley Samuel Stern,  Study Chair
Thomas Julian,  Study Chair

Study ID Numbers:  CDR0000063648; NCCTG-934653; INT-0146
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002575
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08