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

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-08-31

Study Completion Date

2009-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional surgery

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.

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.

Group Type EXPERIMENTAL

conventional surgery

Intervention Type PROCEDURE

Laparoscopic-assisted colectomy

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.

Group Type EXPERIMENTAL

laparoscopic surgery

Intervention Type PROCEDURE

Interventions

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conventional surgery

Intervention Type PROCEDURE

laparoscopic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heidi Nelson, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Huntsville Hospital System

Huntsville, Alabama, United States

Site Status

MBCCOP - Gulf Coast

Mobile, Alabama, United States

Site Status

CCOP - Greater Phoenix

Phoenix, Arizona, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

St. Mary's Hospital

Rogers, Arkansas, United States

Site Status

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, United States

Site Status

Scripps Clinic

La Jolla, California, United States

Site Status

University of California San Diego Cancer Center

La Jolla, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Saint Mary Medical Center - Long Beach

Long Beach, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Naval Medical Center - Oakland

Oakland, California, United States

Site Status

Sutter Cancer Center

Sacramento, California, United States

Site Status

Veterans Affairs Satellite Clinic - Sacramento

Sacramento, California, United States

Site Status

Naval Medical Center - San Diego

San Diego, California, United States

Site Status

Veterans Affairs Medical Center - San Francisco

San Francisco, California, United States

Site Status

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Site Status

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

Site Status

University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program, Inc.

Denver, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

CCOP - Christiana Care Health Services

Wilmington, Delaware, United States

Site Status

Baptist Regional Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status

Sylvester Cancer Center, University of Miami

Miami, Florida, United States

Site Status

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

MD Anderson Cancer Center Orlando

Orlando, Florida, United States

Site Status

Sarasota Memorial Hospital

Sarasota, Florida, United States

Site Status

Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

Medical College of Georgia Comprehensive Cancer Center

Augusta, Georgia, United States

Site Status

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, United States

Site Status