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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
conventional surgery
laparoscopic surgery
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage I colon cancer, stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huntsville Hospital System
  • MBCCOP - Gulf Coast
  • CCOP - Greater Phoenix
  • University of Arkansas for Medical Sciences
  • St. Mary's Hospital
  • Cancer Center and Beckman Research Institute, City of Hope
  • Scripps Clinic
  • University of California San Diego Cancer Center
  • Loma Linda University Medical Center
  • Saint Mary Medical Center - Long Beach
  • CCOP - Bay Area Tumor Institute
  • Naval Medical Center - Oakland
  • Sutter Cancer Center
  • Veterans Affairs Satellite Clinic - Sacramento
  • Naval Medical Center - San Diego
  • Veterans Affairs Medical Center - San Francisco
  • CCOP - Santa Rosa Memorial Hospital
  • Kaiser Permanente Medical Center - Vallejo
  • University of Colorado Cancer Center
  • CCOP - Colorado Cancer Research Program, Inc.
  • Hartford Hospital
  • CCOP - Christiana Care Health Services
  • Baptist Regional Cancer Institute - Jacksonville
  • CCOP - Mount Sinai Medical Center
  • Sylvester Cancer Center, University of Miami
  • MD Anderson Cancer Center Orlando
  • Sarasota Memorial Hospital
  • Winship Cancer Institute
  • CCOP - Atlanta Regional
  • Medical College of Georgia Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Cancer Research Center of Hawaii
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Veterans Affairs Medical Center - Lakeside Chicago
  • MBCCOP-Cook County Hospital
  • Rush-Presbyterian-St. Luke's Medical Center
  • Illinois Masonic Medical Center
  • CCOP - Central Illinois
  • CCOP - Evanston
  • West Suburban Hospital Medical Center
  • Rockford Clinic
  • CCOP - Carle Cancer Center
  • Regional Cancer Center
  • CCOP - Iowa Oncology Research Association
  • Holden Comprehensive Cancer Center
  • CCOP - Wichita
  • Lucille Parker Markey Cancer Center, University of Kentucky
  • Norton Healthcare System
  • Baptist Hospital East - Louisville
  • Louisiana State University Medical Center - New Orleans
  • Tulane University School of Medicine
  • Veterans Affairs Medical Center - New Orleans
  • CCOP - Ochsner
  • Eastern Maine Medical Center
  • Franklin Square Hospital Center
  • National Naval Medical Center
  • Regional Cancer Therapy Center - Frederick
  • New England Medical Center Hospital
  • Boston Medical Center
  • Lahey Clinic - Burlington
  • Berkshire Medical Center
  • Baystate Medical Center
  • University of Massachusetts Memorial Healthcare
  • CCOP - Ann Arbor Regional
  • Michigan State University
  • CCOP - Grand Rapids Clinical Oncology Program
  • CCOP - Kalamazoo
  • Providence Hospital - Southfield
  • CCOP - Duluth
  • Hennepin County Medical Center - Minneapolis
  • CCOP - Metro-Minnesota
  • Keesler Medical Center - Keesler AFB
  • Ellis Fischel Cancer Center - Columbia
  • CCOP - Kansas City
  • St. Louis University School of Medicine
  • CCOP - St. Louis-Cape Girardeau
  • CCOP - Montana Cancer Consortium
  • CCOP - Missouri Valley Cancer Consortium
  • Methodist Cancer Center - Omaha
  • CCOP - Southern Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - East Orange
  • CCOP - Northern New Jersey
  • Newark Beth Israel Medical Center
  • University of New Mexico Cancer Research & Treatment Center
  • Albany Regional Cancer Center
  • CCOP - North Shore University Hospital
  • Champlain Valley Physicians Hospital Medical Center
  • Genesee Surgical Associates
  • Staten Island University Hospital
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Lineberger Comprehensive Cancer Center, UNC
  • CCOP - Southeast Cancer Control Consortium
  • Comprehensive Cancer Center at Wake Forest University
  • Veterans Affairs Medical Center - Fargo
  • CCOP - Merit Care Hospital
  • Akron City Hospital
  • Aultman Cancer Center
  • Jewish Hospital of Cincinnati, Inc.
  • Barrett Cancer Center, The University Hospital
  • South Pointe Hospital
  • CCOP - Columbus
  • Arthur G. James Cancer Hospital - Ohio State University
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • CCOP - Toledo Community Hospital Oncology Program
  • CCOP - Oklahoma
  • Oregon Cancer Center
  • CCOP - Columbia River Program
  • Lehigh Valley Hospital
  • St. Luke's Network - Bethlehem
  • Geisinger Medical Center
  • Albert Einstein Cancer Center
  • Allegheny General Hospital
  • University of Pittsburgh Cancer Institute
  • Veterans Affairs Medical Center - Pittsburgh
  • Reading Hospital and Medical Center
  • CCOP - MainLine Health
  • York Hospital
  • Kent County Memorial Hospital
  • Medical University of South Carolina
  • CCOP - Greenville
  • CCOP - Upstate Carolina
  • CCOP - Sioux Community Cancer Consortium
  • Baptist Regional Cancer Center - Knoxville
  • Veterans Affairs Medical Center - Memphis
  • Medical Group of Texas
  • Kelsey Seybold Clinic
  • Wilford Hall - 59th Medical Wing
  • University of Texas Health Science Center at San Antonio
  • University of Texas Health Center at Tyler
  • Utah Valley Regional Medical Center - Provo
  • Vermont Cancer Center
  • Virginia Oncology Associates - Newport News
  • Eastern Virginia Medical School
  • Veterans Affairs Medical Center - Richmond
  • Massey Cancer Center
  • MBCCOP - Massey Cancer Center
  • Oncology and Hematology Associates of Southwest Virginia, Inc.
  • CCOP - Virginia Mason Research Center
  • Puget Sound Oncology Consortium
  • CCOP - Northwest
  • Camden-Clark Memorial Hospital
  • CCOP - Green Bay
  • CCOP - Marshfield Medical Research and Education Foundation
  • Medical College of Wisconsin
  • Tom Baker Cancer Center - Calgary
  • Cross Cancer Institute
  • CancerCare Manitoba
  • Toronto Sunnybrook Regional Cancer Centre
  • St. Michael's Hospital - Toronto
  • Centre Hospitalier de l'Universite de Montreal
  • Royal Victoria Hospital - Montreal
  • Montreal General Hospital
  • Jewish General Hospital - Montreal
  • Centre Hospitalier Universitaire de Quebec
  • L'Hopital Laval
  • MBCCOP - San Juan
  • Veterans Affairs Medical Center - San Juan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional surgery

Laparoscopic-assisted colectomy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
Overall survival

Secondary Outcome Measures

Morbidity
Mortality
Costs and cost effectiveness between these treatments in this patient population
Compare the differences in quality of life of patients treated with these regimens

Full Information

First Posted
November 1, 1999
Last Updated
July 15, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI), NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00002575
Brief Title
Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
Official Title
A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 1994 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI), NCIC Clinical Trials Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage I colon cancer, stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
810 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Laparoscopic-assisted colectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Primary Outcome Measure Information:
Title
Disease-free survival
Description
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)
Time Frame
Up to 8 years
Title
Overall survival
Time Frame
Up to 8 years
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
Up to 8 years
Title
Mortality
Time Frame
At 30 days
Title
Costs and cost effectiveness between these treatments in this patient population
Time Frame
Up to 8 years
Title
Compare the differences in quality of life of patients treated with these regimens
Time Frame
Up to 8 years

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
21452066
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 93-46-53 (INT 0146). Ann Surg Oncol. 2011 Sep;18(9):2422-31. doi: 10.1245/s10434-011-1650-2. Epub 2011 Mar 31.
Results Reference
result
PubMed Identifier
18948801
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 colon cancer. Ann Surg. 2008 Nov;248(5):746-50. doi: 10.1097/SLA.0b013e31818a157d.
Results Reference
result
PubMed Identifier
15141043
Citation
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.
Results Reference
result
PubMed Identifier
11790211
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. 2002 Jan 16;287(3):321-8. doi: 10.1001/jama.287.3.321.
Results Reference
result

Learn more about this trial

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

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