Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-30 @ 5:29 AM
Study NCT ID:
NCT00189657
Status:
UNKNOWN
Last Update Posted:
2005-09-19
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2005-09-12', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Cancer of the Rectum']}, 'descriptionModule': {'briefSummary': 'The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rectal adenocarcinoma\n* R0 surgery\n* T3, N0, M0 or T4, N0, M0 or N1,2, M0\n* chemotherapy can be started within 8 weeks after surgery\n* Age \\> 18\n* Performance status ECOG \\< 3\n* preoperative radiotherapy allowed\n* preoperative chemotherapy with 5FU +/- LV allowed\n* Neutrophiles \\> 1 500/mm3; Pl. \\> 100 000/mm3\n* Transaminases \\< 2 x UNL; Alcalines Phosphatases \\< 2 x UNL; Bili \\< 1.1 UNL\n* creatininemia \\< 120 µmol/l and/or clearance of creatininemia \\> 60 ml/mn\n* Written informed consent before inclusion\n\nExclusion Criteria:\n\n* postoperative radiotherapy\n* Distant metastases\n* Contraindication to any drug contained in the chemotherapy regimens\n* Any serious active disease or co-morbid medical condition including digestive inflammatory disease\n* Gilbert disease\n* severe toxicity of radiotherapy\n* Pregnancy or breast feeding\n* Absence of contraception in non menopausal women\n* Adult patient unable to give informed consent because of intellectual impairment\n* Concomitant participation to another trial'}, 'identificationModule': {'nctId': 'NCT00189657', 'briefTitle': '5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Association Européenne de Recherche en Oncologie'}, 'orgStudyIdInfo': {'id': 'AERO-R98'}}, 'armsInterventionsModule': {'interventions': [{'name': '5FU/LV Mayo Clinic or LV5FU2', 'type': 'PROCEDURE'}, {'name': 'LV5FU2 + irinotecan', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal Piedbois, MD', 'role': 'CONTACT', 'email': 'pascal.piedbois@hmn.aphp.fr', 'phone': '+ 33 1 49 81 25 82'}], 'facility': 'AERO', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Annie JOUHAUD', 'role': 'CONTACT', 'email': 'annie.jouhaud@aero-eu.org', 'phone': '+ 33 1 43 77 72 10'}], 'overallOfficials': [{'name': 'Pascal Piedbois, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Association Europeenne de Recherche en Oncologie'}, {'name': 'Thierry Andre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GERCOR - Multidisciplinary Oncology Cooperative Group'}, {'name': 'Alain Piolot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Association Europeenne de Recherche en Oncologie'}, {'name': 'Emmanuel Achille, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GERCOR - Multidisciplinary Oncology Cooperative Group'}, {'name': 'Iradj Bobhani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Française de Cancérologie Digestive'}, {'name': 'Jean-Yves Douillard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNICANCER'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Européenne de Recherche en Oncologie', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aventis Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}]}}}