Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With 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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: conventional surgery; Procedure: laparoscopic surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 810
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

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

PRIOR CONCURRENT THERAPY:

Surgery:

• No prohibitive scars/adhesions from prior abdominal surgery

Other:

• No concurrent investigational treatments or invasive diagnostic procedures within 30 days after surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: conventional surgery
EXPERIMENTAL: Laparoscopic-assisted colectomy; 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.	Procedure: laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		Up to 8 years
Disease-free survival	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)	Up to 8 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	At 30 days
Morbidity	Up to 8 years
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

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI); NCIC Clinical Trials Group
• Investigators: Study Chair: Heidi Nelson, MD, Mayo Clinic

Publications and helpful links

General Publications

• Stucky CC, Pockaj BA, Novotny PJ, Sloan JA, Sargent DJ, O'Connell MJ, Beart RW, Skibber JM, Nelson H, Weeks JC. Long-term follow-up and individual item analysis of quality of life assessments related to laparoscopic-assisted colectomy in the COST trial 93-46-53 (INT 0146). Ann Surg Oncol. 2011 Sep;18(9):2422-31. doi: 10.1245/s10434-011-1650-2. Epub 2011 Mar 31.
• Larson DW, Marcello PW, Larach SW, Wexner SD, Park A, Marks J, Senagore AJ, Thorson AG, Young-Fadok TM, Green E, Sargent DJ, Nelson H. Surgeon volume does not predict outcomes in the setting of technical credentialing: results from a randomized trial in colon cancer. Ann Surg. 2008 Nov;248(5):746-50. doi: 10.1097/SLA.0b013e31818a157d.
• Clinical Outcomes of Surgical Therapy Study Group; Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Ota D. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9. doi: 10.1056/NEJMoa032651.
• Weeks JC, Nelson H, Gelber S, Sargent D, Schroeder G; Clinical Outcomes of Surgical Therapy (COST) Study Group. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA. 2002 Jan 16;287(3):321-8. doi: 10.1001/jama.287.3.321.

Study record dates

Study Major Dates

• Study Start: August 1, 1994
• Primary Completion (ACTUAL): May 1, 2004
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: April 9, 2003
• First Posted (ESTIMATE): April 10, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): July 18, 2016
• Last Update Submitted That Met QC Criteria: July 15, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: adenocarcinoma of the colon; stage III colon cancer; stage II colon cancer; stage I colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: NCCTG-934653; NCI-2012-02234 (REGISTRY: CTRP (Clinical Trials Reporting System)); CAN-NCIC-CO12; CDR0000063648 (REGISTRY: PDQ (Physician Data Query))