Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer

Study Overview
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Brief Summary
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RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.

Detailed Description
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OBJECTIVES: Compare local and distant recurrences in patients with mid-rectal cancer treated with wide mesorectal surgical excision with straight colorectal anastomosis versus total mesorectal surgical excision with colonic J pouch coloanal anastomosis. Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures. Compare disease-free survival and overall survival in these patients treated with these two surgical procedures. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo surgical resection with a wide mesorectal excision followed by a straight colorectal anastomosis. Arm II: Patients undergo surgical resection with a total mesorectal excision followed by a colonic J pouch coloanal anastomosis. Patients then receive a temporary ileostomy which is closed 6 weeks later. Patients are followed at 6 weeks, every 4-6 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 800 patients (400 per arm) will be accrued for this study.

Official Title
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Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal 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 rectal cancer by colonoscopy or barium enema Distal margin of tumor arises within 9-15 cm from the anal verge as measured by rigid sigmoidoscopy No synchronous multiple adenocarcinomas Candidate for low anterior surgical resection by laparoscopy or conventional open method No evidence of gross metastatic disease No evidence of peritoneal or pelvic metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: At least 6 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Neoadjuvant or adjuvant chemoradiotherapy allowed Endocrine therapy: Not specified Radiotherapy: See Chemotherapy Surgery: See Disease Characteristics

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: conventional surgery|nan|
|Procedure: laparoscopic surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence at 3 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free and overall survival at 5 years |  |  | 

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