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AzTrials

Colorectal CancerPhase 3NCT00002575

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

A Phase 3 study testing conventional surgery and laparoscopic surgery in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 158 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
conventional surgery and laparoscopic surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
810 participants
Where
158 sitesin 3 countries
Study dates
Aug 1994to Nov 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

158 sites in 3 countries.

158 sites in 3 countries

United States145 sites

  • Akron City Hospital

    Akron, Ohio, 44309

  • Albany Regional Cancer Center

    Albany, New York, 12208

  • University of New Mexico Cancer Research & Treatment Center

    Albuquerque, New Mexico, 87131

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Medical College of Georgia Comprehensive Cancer Center

    Augusta, Georgia, 30912-4000

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • National Naval Medical Center

    Bethesda, Maryland, 20889-5000

  • St. Luke's Network - Bethlehem

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Lahey Clinic - Burlington

    Burlington, Massachusetts, 01805

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Aultman Cancer Center

    Canton, Ohio, 44710

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611-3013

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611

  • MBCCOP-Cook County Hospital

    Chicago, Illinois, 60612

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Jewish Hospital of Cincinnati, Inc.

    Cincinnati, Ohio, 45236

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45267-0502

  • South Pointe Hospital

    Cleveland, Ohio, 44122

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Medical Group of Texas

    Dallas, Texas, 75243

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • Cancer Center and Beckman Research Institute, City of Hope

    Duarte, California, 91010-3000

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Michigan State University

    East Lansing, Michigan, 48824

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • Veterans Affairs Medical Center - Fargo

    Fargo, North Dakota, 58102

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Regional Cancer Therapy Center - Frederick

    Frederick, Maryland, 21701

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • CCOP - Green Bay

    Green Bay, Wisconsin, 54301

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Kelsey Seybold Clinic

    Houston, Texas, 77025

  • Huntsville Hospital System

    Huntsville, Alabama, 35801-4470

  • Regional Cancer Center

    Indianapolis, Indiana, 46219

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242-1009

  • Baptist Regional Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Baptist Regional Cancer Center - Knoxville

    Knoxville, Tennessee, 37901

  • Scripps Clinic

    La Jolla, California, 92037

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • Wilford Hall - 59th Medical Wing

    Lackland Air Force Base, Texas, 78236-5300

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lucille Parker Markey Cancer Center, University of Kentucky

    Lexington, Kentucky, 40536-0093

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Saint Mary Medical Center - Long Beach

    Long Beach, California, 90813-0887

  • Norton Healthcare System

    Louisville, Kentucky, 40202-5070

  • Baptist Hospital East - Louisville

    Louisville, Kentucky, 40207

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • Louisiana State University Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Virginia Oncology Associates - Newport News

    Newport News, Virginia, 23606

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • West Suburban Hospital Medical Center

    Oak Park, Illinois, 60302

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Naval Medical Center - Oakland

    Oakland, California, 94627-5000

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Methodist Cancer Center - Omaha

    Omaha, Nebraska, 68114

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213-3489

  • Veterans Affairs Medical Center - Pittsburgh

    Pittsburgh, Pennsylvania, 15240

  • Berkshire Medical Center

    Pittsfield, Massachusetts, 01201

  • Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901

  • Oregon Cancer Center

    Portland, Oregon, 97201-3098

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Veterans Affairs Medical Center - Richmond

    Richmond, Virginia, 23249

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

  • Genesee Surgical Associates

    Rochester, New York, 14607

  • Rockford Clinic

    Rockford, Illinois, 61103

  • St. Mary's Hospital

    Rogers, Arkansas, 72756

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Veterans Affairs Satellite Clinic - Sacramento

    Sacramento, California, 95820

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Puget Sound Oncology Consortium

    Seattle, Washington, 98109

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • St. Louis University School of Medicine

    St Louis, Missouri, 63104

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • University of Texas Health Center at Tyler

    Tyler, Texas, 75708

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Kent County Memorial Hospital

    Warwick, Rhode Island, 02886

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Healthcare

    Worester, Massachusetts, 01605

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • York Hospital

    York, Pennsylvania, 17315

Other trials in United States

Canada11 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L-4M1

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Puerto Rico2 sites

  • MBCCOP - San Juan

    San Juan, 00927-5800

  • Veterans Affairs Medical Center - San Juan

    San Juan, 00927-5800

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Being tested
conventional surgery, laparoscopic surgery
Keywords
stage I colon cancer, stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00002575
Study groupRoleWhat they receive
Conventional surgeryExperimentalPatients 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.
Receives: Procedure: conventional surgery
Laparoscopic-assisted colectomyExperimentalPatients 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.
Receives: Procedure: laparoscopic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 8 years

  2. Overall survival

    Measured: Up to 8 years

Secondary outcomes (4)

  1. Morbidity

    Measured: Up to 8 years

  2. Mortality

    Measured: At 30 days

  3. Costs and cost effectiveness between these treatments in this patient population

    Measured: Up to 8 years

  4. Compare the differences in quality of life of patients treated with these regimens

    Measured: Up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2003 (estimated)
  2. Study startAug 1994
  3. Primary completionMay 2004
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
810 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002575
Sponsor's protocol ID
NCCTG-934653
Other IDs
NCI-2012-02234, CAN-NCIC-CO12, CDR0000063648
Status last verified
Jul 2016
First submitted
1 Nov 1999
Last updated
18 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21452066

  • 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.

    PubMed 18948801

  • 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.

    PubMed 15141043

  • 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.

    PubMed 11790211

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing conventional surgery and laparoscopic surgery in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 158 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: Up to 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002575, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.

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