Overview

This trial is active, not recruiting.

Conditions colorectal cancer, perioperative/postoperative complications
Treatments conventional surgery, management of therapy complications
Phase phase 3
Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Start date June 2002
Trial size 100 participants
Trial identifier NCT00070005, CDR0000328269, CKTO-2002-02-POCASTER, EU-20247

Summary

RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

PURPOSE: This randomized phase III trial is studying how well J-pouch coloanal anastomosis works compared to side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose supportive care

Primary Outcomes

Measure
Functional outcome as measured by a validated questionnaire
time frame:

Secondary Outcomes

Measure
Quality life as measured by a validated questionnaire
time frame:
Anorectal function as assessed by anorectal manometry and barostat measurements
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the rectum - T2 or T3 disease - Disease located in the mid- or distal rectum - No evidence of metastatic disease - No preexisting grade III or IV incontinence - Completed preoperative radiotherapy (5 x 5 Gy) before study entry PATIENT CHARACTERISTICS: Age - Over 18 Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Working knowledge of the Dutch language PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy to the pelvis Surgery - No prior colon resection - No prior anorectal surgery - No concurrent abdominoperineal resection

Additional Information

Official title A Phase III Randomised Study Of J-Pouch Coloanal Anastomosis Versus Side-To-End Coloanal Anastomosis After Preoperative Radiotherapy And Total Mesorectal Excision In Patients With Mid And Distal Rectal Cancer
Description OBJECTIVES: Primary - Compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with J-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision. Secondary - Compare the quality of life of patients treated with these procedures. - Compare anorectal function in patients treated with these procedures. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and gender. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo total mesorectal excision followed by a J-pouch coloanal anastomosis. - Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis. In both arms, patients receive a temporary ileostomy. The ileostomy is closed after 1 week provided recovery is uneventful and no radiological signs of anastomotic leakage are detected. If early closure is not possible, the ileostomy is closed after 6-8 weeks. Functional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery. PROJECTED ACCRUAL: A minimum of 100 patients (50 per treatment arm) will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).