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Sponsored by: |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070005 |
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.
Condition | Intervention | Phase |
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Colorectal Cancer Perioperative/Postoperative Complications |
Procedure: conventional surgery Procedure: management of therapy complications |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Active Control |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | June 2002 |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the rectum
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Netherlands | |
Academisch Medisch Centrum at University of Amsterdam | |
Amsterdam, Netherlands, 1105 AZ | |
Albert Schweitzerziekenhuis - Locatie Amstelwijck | |
Dordrecht NM, Netherlands, NL-3317 | |
Gelre Ziekenhuizen - Lokatie Lukas | |
Apeldoorn, Netherlands, 7300 DS | |
Isala Klinieken - locatie Weezenlanden | |
Zwolle, Netherlands, 8000 GK | |
St. Lucas - Andreas Ziekenhuis | |
Amsterdam, Netherlands, 1091 AE | |
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
Amsterdam, Netherlands, 1066 CX | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands, 1091 HA | |
Reinier de Graaf Group - Delft | |
Delft, Netherlands, 2625 AD | |
Isala Klinieken - locatie Sophia | |
Zwolle, Netherlands, 8000 GK |
Study Chair: | Roel Bakx, MD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Study ID Numbers: | CDR0000328269, CKTO-2002-02-POCASTER, EU-20247 |
Study First Received: | October 3, 2003 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00070005 History of Changes |
Health Authority: | United States: Federal Government |
perioperative/postoperative complications stage I rectal cancer stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Carcinoma Rectal Cancer Digestive System Diseases Postoperative Complications Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Carcinoma |
Neoplasms Pathologic Processes Neoplasms by Site Digestive System Diseases Postoperative Complications Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |