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

Study Overview
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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.

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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: conventional surgery
* Procedure: laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional surgery<br>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. | Procedure: conventional surgery<br> <br> |
| Experimental: Laparoscopic-assisted colectomy<br>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. | Procedure: laparoscopic surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Up to 8 years | 
| Overall survival |  | Up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | Up to 8 years | 
| Mortality |  | At 30 days | 
| Costs and cost effectiveness between these treatments in this patient population |  | Up to 8 years | 
| Compare the differences in quality of life of patients treated with these regimens |  | Up to 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the colon, stage I colon cancer, stage II colon cancer, stage III colon cancer