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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002575
Enrollment
810
Registered
2003-04-10
Start date
1994-08-31
Completion date
2009-11-30
Last updated
2016-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

stage I colon cancer, stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon

Brief 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. PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.

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.

Interventions

PROCEDUREconventional surgery
PROCEDURElaparoscopic surgery

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
NCIC Clinical Trials Group
CollaboratorNETWORK
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disease-free survivalUp to 8 years* 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)
Overall survivalUp to 8 years

Secondary

MeasureTime frame
MorbidityUp to 8 years
MortalityAt 30 days
Costs and cost effectiveness between these treatments in this patient populationUp to 8 years
Compare the differences in quality of life of patients treated with these regimensUp to 8 years

Countries

Canada, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026