Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00199602
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the prevalence of symptomatic or asymptomatic deep venous thrombosis in cancer patients with implantable device for central venous access with or without prophylaxis :', 'timeFrame': 'Day90'}, {'measure': 'Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy', 'timeFrame': 'Day90'}], 'secondaryOutcomes': [{'measure': '- Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -', 'timeFrame': 'Day90'}, {'measure': '- Frequency of other symptomatic venous thromboembolic events between 3 groups.', 'timeFrame': 'J0, J1, J21, J42, J63 and J90'}, {'measure': 'Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose', 'timeFrame': 'Day90'}, {'measure': '-Costs in the 3 strategies', 'timeFrame': 'J90'}, {'measure': '- Tumoral response to chemotherapy in the 3 groups.', 'timeFrame': 'Day90'}, {'measure': '- Overall survival in each group.', 'timeFrame': 'Day90'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '23636449', 'type': 'RESULT', 'citation': 'Lavau-Denes S, Lacroix P, Maubon A, Preux PM, Genet D, Venat-Bouvet L, Labourey JL, Martin J, Slaouti P, Tubiana-Mathieu N. Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study. Cancer Chemother Pharmacol. 2013 Jul;72(1):65-73. doi: 10.1007/s00280-013-2169-y. Epub 2013 May 1.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients).\n\nStudy period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First line chemotherapy for solid tumor with:\n* Metastatic disease or\n* Involved nodes or\n* Unresectable tumor\n* Indication for Implantable device for central venous access\n* Potential survival \\> 3 months\n* ECOG performance status 0 to 2 (WHO)\n* Age between 18 and 75 years.\n* Social security guaranteed\n* Normal laboratory assessments (platelets\\> 100000/mm3, TP 60%, spontaneous TCA with M/T\\<1.5, TGO and TGP \\< 2xN, serum creatinin\\<120µmol/l)\n* Informed consent signed\n\nExclusion Criteria:\n\n* Inability to understand informed consent or interfering with compliance for treatment or protocol Anti-coagulant treatment -related criteria\n* Acute infectious endocarditis\n* History related with heparin allergy or thrombopenia due to heparin\n* Uncontrolled high blood pressure (systolic blood pressure \\>180 mm Hg and/or diastolic blood pressure \\>110 mm Hg)\n* Hemorrhagic syndrome ongoing\n* Patient with platelet inhibitors treatment\n* Chronic, daily treatment with anti-coagulant therapy (LMWH or AVK), use as preventive or curative level\n* Patient with liver failure (TP\\<60%) or renal insufficiency (creatinin clearance\\< 20 ml/mn)\n* Women with pregnancy and lactating Pathology-related criteria\n* deep venous thrombosis history or pulmonary embolism (\\< 6 months)\n* Clinical suspicious of brain metastasis'}, 'identificationModule': {'nctId': 'NCT00199602', 'briefTitle': 'Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study', 'orgStudyIdInfo': {'id': 'I99006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'lack of drug prophylaxis'}, {'type': 'EXPERIMENTAL', 'label': 'HBPM 2500 UI anti Xa in one subcutaneous injection per day', 'interventionNames': ['Drug: warfarine - low molecular heparin']}, {'type': 'EXPERIMENTAL', 'label': 'warfarine 1mg daily', 'interventionNames': ['Drug: warfarine - low molecular heparin']}], 'interventions': [{'name': 'warfarine - low molecular heparin', 'type': 'DRUG', 'armGroupLabels': ['HBPM 2500 UI anti Xa in one subcutaneous injection per day', 'warfarine 1mg daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87000', 'city': 'Limoges', 'country': 'France', 'facility': 'Oncologie Médicale', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'overallOfficials': [{'name': 'Nicole TUBIANA-MATHIEU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}