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Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information



- 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


- Clinical diagnosis of primary adenocarcinoma

- Involving a single colon segment:

- Right colon from the ileocecal valve up to and including the hepatic

- 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

- 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



- 18 and over

Performance status:

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- Not specified


- Not specified


- See Disease Characteristics

- No prohibitive scars/adhesions from prior abdominal surgery


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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Heidi Nelson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




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



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