J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma
NCT ID: NCT00070005
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2002-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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conventional surgery
management of therapy complications
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Principal Investigators
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Roel Bakx, MD
Role: STUDY_CHAIR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
St. Lucas - Andreas Ziekenhuis
Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, , Netherlands
Reinier de Graaf Group - Delft
Delft, , Netherlands
Albert Schweitzerziekenhuis - Locatie Amstelwijck
Dordrecht NM, , Netherlands
Isala Klinieken - locatie Sophia
Zwolle, , Netherlands
Isala Klinieken - locatie Weezenlanden
Zwolle, , Netherlands
Countries
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Other Identifiers
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CDR0000328269
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20247
Identifier Type: -
Identifier Source: secondary_id
CKTO-2002-02-POCASTER
Identifier Type: -
Identifier Source: org_study_id