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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

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 HospitalAkron, Ohio  44304
National Naval Medical CenterBethesda, Maryland  20889
University of Colorado Cancer CenterDenver, Colorado  80262
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, 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 CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
CCOP - DuluthDuluth, Minnesota  55805
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Medical College of WisconsinMilwaukee, Wisconsin  53226
Huntsville Hospital SystemHuntsville, Alabama  35801
Loma Linda University Medical CenterLoma Linda, California  92354
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
Tulane University School of MedicineNew Orleans, Louisiana  70112
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
York HospitalYork, Pennsylvania  17315
CCOP - GreenvilleGreenville, South Carolina  29615
Wilford Hall - 59th Medical WingLackland Air Force Base, Texas  78236-5300
Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - EvanstonEvanston, Illinois  60201
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
CCOP - Green BayGreen Bay, Wisconsin  54301
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - Gulf CoastMobile, Alabama  36688
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Boston Medical CenterBoston, Massachusetts  02118
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Puget Sound Oncology ConsortiumSeattle, Washington  98109
St. Mary's HospitalRogers, Arkansas  72756
Scripps ClinicLa Jolla, California  92037
Saint Mary Medical Center - Long BeachLong Beach, California  90813-0887
Naval Medical Center - OaklandOakland, California  94627-5000
Sutter Cancer CenterSacramento, California  95816
Veterans Affairs Satellite Clinic - SacramentoSacramento, California  95820
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Hartford HospitalHartford, Connecticut  06102-5037
Sarasota Memorial HospitalSarasota, Florida  34239
Winship Cancer InstituteAtlanta, Georgia  30322
Medical College of Georgia Comprehensive Cancer CenterAugusta, Georgia  30912-4000
Illinois Masonic Medical CenterChicago, Illinois  60657
MBCCOP-Cook County HospitalChicago, Illinois  60612
West Suburban Hospital Medical CenterOak Park, Illinois  60302
Rockford ClinicRockford, Illinois  61103
Regional Cancer CenterIndianapolis, Indiana  46219
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Lucille Parker Markey Cancer Center, University of KentuckyLexington, Kentucky  40536-0093
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
Norton Healthcare SystemLouisville, Kentucky  40202-5070
Louisiana State University Medical Center - New OrleansNew Orleans, Louisiana  70112
Eastern Maine Medical CenterBangor, Maine  04401
Franklin Square Hospital CenterBaltimore, Maryland  21237
Regional Cancer Therapy Center - FrederickFrederick, Maryland  21701
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
Berkshire Medical CenterPittsfield, Massachusetts  01201
Baystate Medical CenterSpringfield, Massachusetts  01199
University of Massachusetts Memorial HealthcareWorester, Massachusetts  01605
Michigan State UniversityEast Lansing, Michigan  48824
St. Louis University School of MedicineSaint Louis, Missouri  63104
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
Albany Regional Cancer CenterAlbany, New York  12208
Genesee Surgical AssociatesRochester, New York  14607
Staten Island University HospitalStaten Island, New York  10305
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Aultman Cancer CenterCanton, Ohio  44710
Jewish Hospital of Cincinnati, Inc.Cincinnati, Ohio  45236
South Pointe HospitalCleveland, Ohio  44122
CCOP - OklahomaTulsa, Oklahoma  74136
Oregon Cancer CenterPortland, Oregon  97201-3098
St. Luke's Network - BethlehemBethlehem, Pennsylvania  18015
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Kent County Memorial HospitalWarwick, Rhode Island  02886
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Medical Group of TexasDallas, Texas  75243
Kelsey Seybold ClinicHouston, Texas  77025
University of Texas Health Center at TylerTyler, Texas  75708
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Virginia Oncology Associates - Newport NewsNewport News, Virginia  23606
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Camden-Clark Memorial HospitalParkersburg, West Virginia  26102