Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer

Colorectal Cancer Clinical Trial

Official title:

A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002575
• Other study ID #: NCCTG-934653
• Secondary ID: NCI-2012-02234CA
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 15, 2016
• Start date: August 1994
• Est. completion date: November 2009

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: November 2009
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• conventional surgery

• laparoscopic surgery

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI), NCIC Clinical Trials Group

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (4)

Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9. — View Citation

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 c — View Citation

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 — View Citation

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. 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Overall survival		Up to 8 years	No
Secondary	Morbidity		Up to 8 years	No
Secondary	Mortality		At 30 days	No
Secondary	Costs and cost effectiveness between these treatments in this patient population		Up to 8 years	No
Secondary	Compare the differences in quality of life of patients treated with these regimens		Up to 8 years	No