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Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer Clinical research trials and Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer. Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer  Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
For Condition: stage 3 colon cancer,stage 1 colon cancer,adenocarcinoma of the colon,stage 2 colon cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group,Eastern Cooperative Oncology Group,Radiation Therapy Oncology Group,Cancer and Leukemia Group B,National Cancer Institute of Canada,National Surgical Adjuvant Breast and Bowel Project (NSABP),North Central Cancer Treatment Group
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelO'Connell, Study Chair, North Central Cancer Treatment Group
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
St. Louis University School of Medicine
St. Louis, Missouri, 63104
United States
Scripps Clinic
La Jolla, California, 92037
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
United States
Naval Medical Center - Oakland
Oakland, California, 94627-5000
United States
Berkshire Medical Center
Pittsfield, Massachusetts, 01201
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
Winship Cancer Institute
Atlanta, Georgia, 30322
United States
National Naval Medical Center
Bethesda, Maryland, 20889-5000
United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
United States
Naval Medical Center - San Diego
San Diego, California, 92134-3202
United States
Hartford Hospital
Hartford, Connecticut, 06102-5037
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Regional Cancer Center
Indianapolis, Indiana, 46219
United States
St. Mary's Hospital
Rogers, Arkansas, 72756
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
Kent County Memorial Hospital
Warwick, Rhode Island, 02886
United States
Veterans Affairs Satellite Clinic - Sacramento
Sacramento, California, 95820
United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, 78236-5300
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
Medical Group of Texas
Dallas, Texas, 75243
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0502
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Huntsville Hospital System
Huntsville, Alabama, 35801-4470
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26102
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
South Pointe Hospital
Cleveland, Ohio, 44122
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
MBCCOP - San Juan
San Juan, , 00927-5800
Puerto Rico
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, 87131
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, 18015
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Virginia Oncology Associates - Newport News
Newport News, Virginia, 23606
United States
Norton Healthcare System
Louisville, Kentucky, 40202-5070
United States
University of Texas Health Center at Tyler
Tyler, Texas, 75708
United States
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, 45236
United States
Puget Sound Oncology Consortium
Seattle, Washington, 98109
United States
Illinois Masonic Medical Center
Chicago, Illinois, 60657
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
West Suburban Hospital Medical Center
Oak Park, Illinois, 60302
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Akron City Hospital
Akron, Ohio, 44309
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Royal Victoria Hospital - Montreal
Montreal, Quebec, H3A 1A1
Canada
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Albany Regional Cancer Center
Albany, New York, 12208
United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
York Hospital
York, Pennsylvania, 17315
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2
Canada
Oregon Cancer Center
Portland, Oregon, 97201-3098
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Lahey Clinic - Burlington
Burlington, Massachusetts, 01805
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Michigan State University
East Lansing, Michigan, 48824
United States
Aultman Cancer Center
Canton, Ohio, 44710
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Genesee Surgical Associates
Rochester, New York, 14607
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
United States
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1
Canada
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, 37901
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415
United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Canada
Medical College of Georgia Comprehensive Cancer Center
Augusta, Georgia, 30912-4000
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Veterans Affairs Medical Center - San Juan
San Juan, , 00927-5800
Puerto Rico
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Regional Cancer Therapy Center - Frederick
Frederick, Maryland, 21701
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
CCOP - Green Bay
Green Bay, Wisconsin, 54301
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Eastern Virginia Medical School
Norfolk, Virginia, 23507
United States
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, 12901
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
Rockford Clinic
Rockford, Illinois, 61103
United States
Kelsey Seybold Clinic
Houston, Texas, 77025
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
University of Massachusetts Memorial Healthcare
Worcester, Massachusetts, 01605
United States
MBCCOP-Cook County Hospital
Chicago, Illinois, 60612
United States
Staten Island University Hospital
Staten Island, New York, 10305
United States
Saint Mary Medical Center - Long Beach
Long Beach, California, 90813-0887
United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Additional Information:
Study ID Numbers: CDR0000063648; NCCTG-934653,INT-0146
Study Start Date: June 1995
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002575
Other Stage 3 Colon Cancer Studies:
1. Comparison of Adjuvant Combination Chemotherapy Regimens in Treating Patients With Resected Stage III Colon Cancer
2. Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
3. Genetic Study in Patients With Stage II or Stage III Colon Cancer
4. Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
5. Combination Chemotherapy in Treating Patients With Colorectal Cancer
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other Virginia Clinical Trials
Other Richmond Clinical Trials
Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
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