Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT00210002
Status:
TERMINATED
Last Update Posted:
2006-11-14
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 55}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2006-11-13', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological response rate for each group.'}], 'secondaryOutcomes': [{'measure': 'To determine tolerance for ferric saccharose (Venofer®)'}, {'measure': "To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)"}, {'measure': "To determine percentage of hemoglobin rate's correction"}, {'measure': "To determine biological parameters's evolution"}]}, 'conditionsModule': {'keywords': ['Neoplasms', 'Solid', 'Anemia', 'darbepoetin alfa', 'ferric saccharose', 'Venofer®', 'Aranesp®'], 'conditions': ['Neoplasms', 'Anemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Well-informed written consent, signed by the patient\n* Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis\n* Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9\\<Hb\\<12 g/dl; Women: 9\\<Hb\\<11 g/dl.\n* Patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study\n* Patients with life expectancy higher than three months\n* Patient with general conditions compatible with the study's follow-up\n\nExclusion Criteria:\n\n* Contra-indication for Venofer\n* Anemia which can have curative treatment\n* Bloody transfusion during the previous four weeks\n* Documented or suspected medullary invasion\n* Uncontrolled arterial hypertension\n* Acute bacterial infection\n* Transferrin saturation's coefficient\n* Pregnancy\n* Ferric salts oral treatment interrupted since less than one week\n* Patient with bad french language's comprehension\n* Patient with a major psychiatric pathology\n* Patient under guardianship, trusteeship or justice safeguard"}, 'identificationModule': {'nctId': 'NCT00210002', 'briefTitle': 'Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.', 'orgStudyIdInfo': {'id': '03 DIVE 01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Darbepoetin alfa (Aranesp®)', 'type': 'DRUG'}, {'name': 'Ferric saccharose(Venofer®)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Castres', 'country': 'France', 'facility': 'Centre Hospitalier de Castres', 'geoPoint': {'lat': 43.60527, 'lon': 2.24088}}, {'city': 'Montauban', 'country': 'France', 'facility': 'Centre Hospitalier de Montauban', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Centre Hospitalier Joseph Ducuing', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Roland Dugat, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Claudius Regaud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}}}}