Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT00208260
Status:
COMPLETED
Last Update Posted:
2010-06-16
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intensified Chemotherapy in CRC After Resection of Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C480833', 'term': 'IFL protocol'}, {'id': 'C410216', 'term': 'Folfox protocol'}, {'id': 'C000627770', 'term': 'folfirinox'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-15', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response', 'timeFrame': 'end of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'during study treatment'}, {'measure': 'Survival', 'timeFrame': '2 years'}, {'measure': 'Secondary resection', 'timeFrame': 'surgery after chemotherapy'}]}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Liver Metastases', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': 'Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven adenocarcinoma of the colon or rectum without previous resection, or clinically asymptomatic (with or without stent)\n* Hepatic unresectable metastases R0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver.\n* Not optimally resectable metastases\n* Extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable.\n* Synchronous and metachronous hepatic metastases\n* WHO performance status 0-1\n* Adjuvant chemotherapy allowed, except oxaliplatin and irinotecan based combination.\n* No prior treatment of the liver metastases, whatever.\n* Life expectancy equal or more than 3 months\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00208260', 'briefTitle': 'Intensified Chemotherapy in CRC After Resection of Liver Metastases', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.', 'orgStudyIdInfo': {'id': 'METHEP/2004/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'FOLFIRI', 'interventionNames': ['Drug: FOLFIRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'FOLFOX-4', 'interventionNames': ['Drug: FOLFOX-4']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'FOLFIRI-HD', 'interventionNames': ['Drug: FOLFIRI-HD']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'FOLFOX-7', 'interventionNames': ['Drug: FOLFOX-7']}, {'type': 'EXPERIMENTAL', 'label': 'E', 'description': 'FOLFIRINOX', 'interventionNames': ['Drug: FOLFIRINOX']}], 'interventions': [{'name': 'FOLFIRI', 'type': 'DRUG', 'description': 'FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks', 'armGroupLabels': ['A']}, {'name': 'FOLFOX-4', 'type': 'DRUG', 'description': 'FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks', 'armGroupLabels': ['B']}, {'name': 'FOLFIRI-HD', 'type': 'DRUG', 'description': 'High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks', 'armGroupLabels': ['C']}, {'name': 'FOLFOX-7', 'type': 'DRUG', 'description': 'FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks', 'armGroupLabels': ['D']}, {'name': 'FOLFIRINOX', 'type': 'DRUG', 'description': 'FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks', 'armGroupLabels': ['E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "CRLC Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Marc YCHOU, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CRLC Val d'Aurelle"}, {'name': 'Michel RIVOIRE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CRLC Leon Berard - Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}, {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}]}}}