Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00070005
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2003-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2003-10-03', 'studyFirstSubmitQcDate': '2003-10-06', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome as measured by a validated questionnaire'}], 'secondaryOutcomes': [{'measure': 'Quality life as measured by a validated questionnaire'}, {'measure': 'Anorectal function as assessed by anorectal manometry and barostat measurements'}]}, 'conditionsModule': {'keywords': ['perioperative/postoperative complications', 'stage I rectal cancer', 'stage II rectal cancer', 'stage III rectal cancer', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer', 'Perioperative/Postoperative Complications']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* Compare the quality of life of patients treated with these procedures.\n* Compare anorectal function in patients treated with these procedures.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and gender. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo total mesorectal excision followed by a J-pouch coloanal anastomosis.\n* Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis.\n\nIn 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.\n\nFunctional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery.\n\nPROJECTED ACCRUAL: A minimum of 100 patients (50 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the rectum\n\n * T2 or T3 disease\n* Disease located in the mid- or distal rectum\n* No evidence of metastatic disease\n* No preexisting grade III or IV incontinence\n* Completed preoperative radiotherapy (5 x 5 Gy) before study entry\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* WHO 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* Working knowledge of the Dutch language\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* No prior radiotherapy to the pelvis\n\nSurgery\n\n* No prior colon resection\n* No prior anorectal surgery\n* No concurrent abdominoperineal resection'}, 'identificationModule': {'nctId': 'NCT00070005', 'briefTitle': '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', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CKTO-2002-02-POCASTER'}, 'secondaryIdInfos': [{'id': 'CDR0000328269', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20247'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'management of therapy complications', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1091 AE', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'St. Lucas - Andreas Ziekenhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1091 HA', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum at University of Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '7300 DS', 'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuizen - Lokatie Lukas', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': '2625 AD', 'city': 'Delft', 'country': 'Netherlands', 'facility': 'Reinier de Graaf Group - Delft', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'zip': 'NL-3317', 'city': 'Dordrecht NM', 'country': 'Netherlands', 'facility': 'Albert Schweitzerziekenhuis - Locatie Amstelwijck'}, {'zip': '8000 GK', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken - locatie Sophia', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '8000 GK', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken - locatie Weezenlanden', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Roel Bakx, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}}}}