Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-26 @ 1:15 PM
Study NCT ID:
NCT00536458
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2007-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Localized Low Grade Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'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': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-31', 'studyFirstSubmitDate': '2007-09-26', 'studyFirstSubmitQcDate': '2007-09-26', 'lastUpdatePostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'failure free survival at 5 years', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'overall survival at 5 years', 'timeFrame': '5 years'}, {'measure': 'response rates at the end of the treatment', 'timeFrame': '6 months'}, {'measure': 'prognstic value of molecular analyses in blood and marrow', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['localized low grade lymphoma', 'Chemotherapy', 'Radiotherapy', 'Molecular analyses', 'primary'], 'conditions': ['Lymphoma, Low-Grade']}, 'descriptionModule': {'briefSummary': 'To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma', 'detailedDescription': 'The standard treatment ol localized low grade lymphomas is Radiotherapy alone can offer long term remissions to some patients .\n\nNo study have clearly demonstrated the interest of chemotherapy. The purpose of the study is to determine wether prednisone administrated after first line local radiotherapy (30 GY) can pre in the treatment of localized low grade lymphomas of adult patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low grade lymphoma defined according to the Ann Arbor classification\n* localized\n\nExclusion Criteria:\n\n* Subjects unable to signed informed consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00536458', 'briefTitle': 'Treatment of Localized Low Grade Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'French Innovative Leukemia Organisation'}, 'officialTitle': 'Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie', 'orgStudyIdInfo': {'id': '01 02'}, 'secondaryIdInfos': [{'id': 'GOELAMS 01 02'}, {'id': 'GOELNH LOGLOC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'radiotherapy', 'description': 'minichep + radiotherapy', 'interventionNames': ['Procedure: radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'MINI CHEP', 'interventionNames': ['Drug: MINI CHEP']}], 'interventions': [{'name': 'radiotherapy', 'type': 'PROCEDURE', 'description': 'mini chep+ radiotherapy', 'armGroupLabels': ['radiotherapy']}, {'name': 'MINI CHEP', 'type': 'DRUG', 'description': 'chemotherapy minichep 6 courses', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'Regional university hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'eric DECONINCK, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Innovative Leukemia Organisation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}}}}