Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2025-12-30 @ 12:41 AM
Study NCT ID:
NCT01242566
Status:
COMPLETED
Last Update Posted:
2010-11-17
First Post:
2010-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temozolomide in Elderly Patients With KPS < 70
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-16', 'studyFirstSubmitDate': '2010-11-16', 'studyFirstSubmitQcDate': '2010-11-16', 'lastUpdatePostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '12 months'}, {'measure': 'adverse events', 'timeFrame': '12 months', 'description': 'term, grade, frequency'}, {'measure': 'Health-related quality of life', 'timeFrame': '12 months', 'description': 'KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)'}, {'measure': 'Cognitive functioning', 'timeFrame': '12 months', 'description': 'characterized by MMSE'}, {'measure': 'Efficacy according to MGMT Promoter methylation status', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Temozolomide', 'Elderly', 'Glioblastoma', 'Karnofsky performance score (KPS)'], 'conditions': ['Primary Brain Tumor', 'Glioblastoma']}, 'descriptionModule': {'briefSummary': 'The management of glioblastoma in elderly patients with poor performance status (KPS\\<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population', 'detailedDescription': 'This trial was conducted to evaluate the efficacy, in terms of survival and quality of life, and safety of up-front temozolomide in elderly GBM patients with poor performance status.\n\nPatients of 70 years of age or older were eligible to participate in this prospective non-randomised multicentric phase II study if they had newly diagnosed and histologically proven glioblastoma on the basis of the WHO classification, and a postoperative KPS between 30 and 60.\n\nTreatment consisted of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity.\n\nPatients were assessed at least every month by means of physical and neurological examinations, KPS, health-related EORTC questionnaires (QLQ-C30 and QLQ-BN20), and MMSE. Complete blood counts and blood chemistry were drawn before each temozolomide cycle; the earlier were also checked every 10 days during the first 2 cycles and every 2 weeks afterwards. CT or MRI studies were repeated every 2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed supratentorial glioblastoma\n* Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy\n* Patients aged 70 years or older\n* KPS above 30 and below 70\n* Life expectancy higher than 4 weeks\n* Clinical examination at baseline\n* Affiliation to Social Security or mandatory beneficiary\n* Patient being informed and obtention of written informed consent\n\nExclusion Criteria:\n\n* Prior surgical resection dated more than 1 month before inclusion\n* Prior brain radiotherapy or chemotherapy\n* Severe underlying disease which could interfere with survival\n* History of hypersensibility reaction on temozolomide components\n* Severe bone marrow hypoplasia\n* Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal\n* Absolute neutrophil count \\< 1.5x109 cells per liter\n* Platelet count \\< 100x109 cells per liter\n* Hemoglobin \\< 9 g/dl\n* Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy'}, 'identificationModule': {'nctId': 'NCT01242566', 'acronym': 'TAG', 'briefTitle': 'Temozolomide in Elderly Patients With KPS < 70', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).', 'orgStudyIdInfo': {'id': 'P060102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'temozolomide', 'description': 'Administration of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity', 'interventionNames': ['Drug: Temozolomide']}], 'interventions': [{'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['Temodar, Temodal'], 'description': 'orally 150-200 mg/m2/day for 5 consecutive days every 4 week', 'armGroupLabels': ['temozolomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Pitie salpetriere hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'DELATTRE Jean-Yves, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Association de Neuro-Oncologues d'Expression Francaise", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Isabelle Brindel', 'oldOrganization': 'Department Clinical Research'}}}}