Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-04 @ 3:08 PM
Study NCT ID:
NCT00503594
Status:
UNKNOWN
Last Update Posted:
2012-07-30
First Post:
2007-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-27', 'studyFirstSubmitDate': '2007-07-18', 'studyFirstSubmitQcDate': '2007-07-18', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'at one year'}], 'secondaryOutcomes': [{'measure': 'Overall survival:median and overall survival', 'timeFrame': 'at one and two years'}, {'measure': 'Response rates', 'timeFrame': 'at end of treatment'}, {'measure': 'Toxicity', 'timeFrame': 'during treatment'}, {'measure': 'Late toxicity', 'timeFrame': '2 to 5 years after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary central nervous system lymphoma', 'Brain lymphoma', 'Elderly', 'Chemotherapy', 'Methotrexate', 'Temozolomide', 'Procarbazine', 'Vincristine', 'Cytarabine'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '17134114', 'type': 'RESULT', 'citation': 'Omuro AM, Abrey LE. Chemotherapy for primary central nervous system lymphoma. Neurosurg Focus. 2006 Nov 15;21(5):E12. doi: 10.3171/foc.2006.21.5.13.'}, {'pmid': '26688235', 'type': 'DERIVED', 'citation': 'Omuro A, Chinot O, Taillandier L, Ghesquieres H, Soussain C, Delwail V, Lamy T, Gressin R, Choquet S, Soubeyran P, Huchet A, Benouaich-Amiel A, Lebouvier-Sadot S, Gyan E, Touitou V, Barrie M, del Rio MS, Gonzalez-Aguilar A, Houillier C, Delgadillo D, Lacomblez L, Tanguy ML, Hoang-Xuan K. Methotrexate and temozolomide versus methotrexate, procarbazine, vincristine, and cytarabine for primary CNS lymphoma in an elderly population: an intergroup ANOCEF-GOELAMS randomised phase 2 trial. Lancet Haematol. 2015 Jun;2(6):e251-9. doi: 10.1016/S2352-3026(15)00074-5. Epub 2015 Jun 3.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov', 'label': 'A review on chemotherapy options for primary central nervous system lymphoma'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) :\n\n* Methotrexate, procarbazine, vincristine and cytarabine\n* Methotrexate and temozolomide', 'detailedDescription': 'The aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy.\n\nPatients will be randomized to receive one of the two regimens in one of the participating centers. Neuropsychological evaluation will be performed in all patients. Patients will be followed with serial MRIs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary central nervous system lymphoma histologically confirmed by brain biopsy, CSF cytology or vitrectomy\n* KPS 40 or higher\n* Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan\n* Leucocytes\\>3.500/mm3, platelets\\>130.000/mm3, Bilirubin \\< 2 mg, transaminases \\< 2.5 N), creatinine \\< 150 μM/l, creatinine clearance \\> 40 ml/min\n* Age ≥ 60 years\n* Negative HIV test\n* Signature of informed consent\n\nExclusion Criteria:\n\n* previous cranial radiotherapy\n* prior chemotherapy for primary central nervous system lymphoma\n* presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )\n* systemic lymphoma (outside the CNS)\n* Isolated ocular lymphoma\n* Immunosuppressed patients (HIV , use of immunosuppressors)\n* Other uncontrolled or progressive disease compromising shot-term survival\n* Severe renal or hepatic disease\n* Patients not legally covered by the French Social Security\n* Inability to swallow the medication'}, 'identificationModule': {'nctId': 'NCT00503594', 'acronym': 'CNSLymphoma', 'briefTitle': 'Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Multicenter Randomized Phase II Study of Methotrexate (MTX) and Temozolomide Versus MTX, Procarbazine, Vincristine and Cytarabine for Primary CNS Lymphoma (PCNSL) in the Elderly', 'orgStudyIdInfo': {'id': 'P060239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Comparative evaluation of the efficiency of a new protocol of the primitive LYMPHOME of the central nervous system ( LPSNC) to the old subject, associating Methotrexate and Temozolomide with regard to a standard protocol associating Methotrexate, Procarbazine, Vincristine and Cytarabine.', 'interventionNames': ['Drug: Methotrexate and temozolomide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bras conventional', 'description': 'bras conventional', 'interventionNames': ['Drug: Methotrexate , procarbazine ,vincristine ,cytarabine']}], 'interventions': [{'name': 'Methotrexate and temozolomide', 'type': 'DRUG', 'description': 'Methotrexate and temozolomide', 'armGroupLabels': ['1']}, {'name': 'Methotrexate , procarbazine ,vincristine ,cytarabine', 'type': 'DRUG', 'description': 'Methotrexate , procarbazine ,vincristine ,cytarabine', 'armGroupLabels': ['bras conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antonio OMURO, MD,PhD', 'role': 'CONTACT', 'email': 'antonio.omuro@psl.aphp.fr', 'phone': '+ 33(0) 1 42 16 41 60'}], 'facility': 'Groupe hospitalier la Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Antonio OMURO, MD,PhD', 'role': 'CONTACT', 'email': 'antonio.omuro@psl.aphp.fr', 'phone': '+ 33(0) 1 42 16 41 60'}], 'overallOfficials': [{'name': 'Antonio OMURO, MD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}