A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
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.
- 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 810 patients will be accrued for this study within 3 years.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Heidi Nelson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000063648
NCT ID:
NCT00002575
Start Date:
August 1994
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage I colon cancer
- stage II colon cancer
- stage III colon cancer
- adenocarcinoma of the colon
- Colonic Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| National Naval Medical Center | Bethesda, Maryland 20889 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Vermont Cancer Center | Burlington, Vermont 05401-3498 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
| CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| New England Medical Center Hospital | Boston, Massachusetts 02111 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Huntsville Hospital System | Huntsville, Alabama 35801 |
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Methodist Cancer Center - Omaha | Omaha, Nebraska 68114 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| York Hospital | York, Pennsylvania 17315 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Wilford Hall - 59th Medical Wing | Lackland Air Force Base, Texas 78236-5300 |
| Massey Cancer Center | Richmond, Virginia 23298-0037 |
| CCOP - Evanston | Evanston, Illinois 60201 |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
| CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
| CCOP - Green Bay | Green Bay, Wisconsin 54301 |
| Baptist Regional Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
| Puget Sound Oncology Consortium | Seattle, Washington 98109 |
| St. Mary's Hospital | Rogers, Arkansas 72756 |
| Scripps Clinic | La Jolla, California 92037 |
| Saint Mary Medical Center - Long Beach | Long Beach, California 90813-0887 |
| Naval Medical Center - Oakland | Oakland, California 94627-5000 |
| Sutter Cancer Center | Sacramento, California 95816 |
| Veterans Affairs Satellite Clinic - Sacramento | Sacramento, California 95820 |
| Naval Medical Center - San Diego | San Diego, California 92134-3202 |
| Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
| Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
| Hartford Hospital | Hartford, Connecticut 06102-5037 |
| Sarasota Memorial Hospital | Sarasota, Florida 34239 |
| Winship Cancer Institute | Atlanta, Georgia 30322 |
| Medical College of Georgia Comprehensive Cancer Center | Augusta, Georgia 30912-4000 |
| Illinois Masonic Medical Center | Chicago, Illinois 60657 |
| MBCCOP-Cook County Hospital | Chicago, Illinois 60612 |
| West Suburban Hospital Medical Center | Oak Park, Illinois 60302 |
| Rockford Clinic | Rockford, Illinois 61103 |
| Regional Cancer Center | Indianapolis, Indiana 46219 |
| Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
| Lucille Parker Markey Cancer Center, University of Kentucky | Lexington, Kentucky 40536-0093 |
| Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
| Norton Healthcare System | Louisville, Kentucky 40202-5070 |
| Louisiana State University Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| Eastern Maine Medical Center | Bangor, Maine 04401 |
| Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| Regional Cancer Therapy Center - Frederick | Frederick, Maryland 21701 |
| Lahey Clinic - Burlington | Burlington, Massachusetts 01805 |
| Berkshire Medical Center | Pittsfield, Massachusetts 01201 |
| Baystate Medical Center | Springfield, Massachusetts 01199 |
| University of Massachusetts Memorial Healthcare | Worester, Massachusetts 01605 |
| Michigan State University | East Lansing, Michigan 48824 |
| St. Louis University School of Medicine | Saint Louis, Missouri 63104 |
| University of New Mexico Cancer Research & Treatment Center | Albuquerque, New Mexico 87131 |
| Albany Regional Cancer Center | Albany, New York 12208 |
| Genesee Surgical Associates | Rochester, New York 14607 |
| Staten Island University Hospital | Staten Island, New York 10305 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| Veterans Affairs Medical Center - Fargo | Fargo, North Dakota 58102 |
| Aultman Cancer Center | Canton, Ohio 44710 |
| Jewish Hospital of Cincinnati, Inc. | Cincinnati, Ohio 45236 |
| South Pointe Hospital | Cleveland, Ohio 44122 |
| CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
| Oregon Cancer Center | Portland, Oregon 97201-3098 |
| St. Luke's Network - Bethlehem | Bethlehem, Pennsylvania 18015 |
| Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
| Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
| Kent County Memorial Hospital | Warwick, Rhode Island 02886 |
| Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
| Medical Group of Texas | Dallas, Texas 75243 |
| Kelsey Seybold Clinic | Houston, Texas 77025 |
| University of Texas Health Center at Tyler | Tyler, Texas 75708 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Virginia Oncology Associates - Newport News | Newport News, Virginia 23606 |
| Eastern Virginia Medical School | Norfolk, Virginia 23507 |
| Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
| Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
