Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT01421316
Status:
TERMINATED
Last Update Posted:
2015-06-04
First Post:
2011-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hair-sparing Whole Brain Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'whyStopped': 'No reduction in hair loss 1 month after treatment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2011-08-17', 'studyFirstSubmitQcDate': '2011-08-19', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The European Organization for Research and Treatment of Cancer (EORTC)quality of life questionnaire (C15-PAL and BN20) measured at 1 month following treatment.', 'timeFrame': 'At 1 month.', 'description': 'Quality of life questionnaires are used.'}], 'secondaryOutcomes': [{'measure': 'Hair quality before treatment and at 1 month following treatment.', 'timeFrame': 'at 1 month following treatment', 'description': 'Key measurements: trichogram are used.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients treated with whole brain radiotherapy in the setting of brain metastases', 'Patients treated with whole brain radiotherapy in the prophylactic treatment for small cell lung cancer (extended disease).'], 'conditions': ['Brain Metastases', 'Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this limited survival it is important to consider quality of life (QOL) when treating these patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in patients with brain metastases. Both fatigue and hair loss were reported to have the largest decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung cancer. Recent technological improvements in patient positioning and treatment planning will allow us to treat the whole brain with reduced margins, allowing better sparing of the scalp. In view of the large impact of hair loss on quality of life, the investigators hypothesize to see an improved quality of life with scalp sparing techniques.\n\nStudy hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent clinically important improvement in QOL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Brain metastases\n* Age ≥ 18 years.\n* Signed informed consent\n* Recursive Partitioning Analysis (RPA) class III patients\n* Recursive Partitioning Analysis (RPA) class I-II patients and \\>3 brain metastases\n* Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT).\n\nExclusion Criteria:\n\n* Previous whole brain radiotherapy'}, 'identificationModule': {'nctId': 'NCT01421316', 'briefTitle': 'Hair-sparing Whole Brain Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Reducing Hair Loss With Volumetric Arc Therapy in Patients Treated With Whole Brain Radiotherapy: a Phase II Trial', 'orgStudyIdInfo': {'id': '2011/504'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Whole brain radiotherapy with volumetric arc therapy', 'type': 'RADIATION', 'description': 'Whole brain radiotherapy with volumetric arc therapy is used.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital, Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}