Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-04-13 @ 2:43 AM
Study NCT ID:
NCT03002532
Status:
UNKNOWN
Last Update Posted:
2016-12-23
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hippocampal-sparing Whole Brain Radiotherapy for Brain Metastases From Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], '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': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2016-12-20', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neurocognitive function', 'timeFrame': '1 years', 'description': 'delayed recall using Hopkins Verbal Learning Test'}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '2 years', 'description': 'Mini-Mental State Examination'}, {'measure': 'patient-reported quality of life', 'timeFrame': '2 years', 'description': 'Spitzer Quality of Life Index'}, {'measure': 'time to intracranial progression', 'timeFrame': '2 years'}, {'measure': 'overall survival after brain metastases', 'timeFrame': '2.5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'Brain metastasis', 'Whole brain radiotherapy', 'Hippocampal avoidance', 'Neurocognitive function', 'intracranial failure'], 'conditions': ['Breast Cancer Metastatic', 'Brain Metastases']}, 'referencesModule': {'references': [{'pmid': '26674923', 'type': 'RESULT', 'citation': 'Sun B, Huang Z, Wu S, Shen G, Cha L, Meng X, Ding L, Wang J, Song S. Incidence and relapse risk of intracranial metastases within the perihippocampal region in 314 patients with breast cancer. Radiother Oncol. 2016 Jan;118(1):181-6. doi: 10.1016/j.radonc.2015.11.010. Epub 2015 Dec 7.'}, {'pmid': '27659537', 'type': 'RESULT', 'citation': 'Sun B, Huang Z, Wu S, Ding L, Shen G, Cha L, Wang J, Song S. Cystic brain metastasis is associated with poor prognosis in patients with advanced breast cancer. Oncotarget. 2016 Nov 8;7(45):74006-74014. doi: 10.18632/oncotarget.12176.'}]}, 'descriptionModule': {'briefSummary': 'Based on evidence that radiation-induced damage to the hippocampus plays a considerable role in neurocognitive decline after cranial irradiation, hippocampal-sparing whole brain radiation therapy (HS-WBRT) has been proposed. This study will investigate the neurocognitive function and prognosis between HS-WBRT and conventional WBRT for the treatment of brain metastases from breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with advanced breast cancer who is confirmed historically.\n* New developing brain metastases (BM) is confirmed by gadolinium contrast-enhanced magnetic resonance imaging (MRI), with or without clinical symptoms and pathology, and without a history of BM treatment.\n* At least 2 BM lesions with the diameter of the largest lesion \\< 40 mm is eligible. And the distance from the border of a mass to the hippocampal margin should be more than 15 mm.\n* The Eastern Cooperative Oncology Group (ECOG) is from 0 to 2, and the expected life expectancy is ≥3 months.\n\nExclusion Criteria:\n\n* Concurrent chemoradiation.\n* Patient who had received cranial irradiation previously.\n* Patient who are enrolled in other clinical trial at the same time.\n* Patient who has severe co-morbidity or infection.'}, 'identificationModule': {'nctId': 'NCT03002532', 'briefTitle': 'Hippocampal-sparing Whole Brain Radiotherapy for Brain Metastases From Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital to Academy of Military Medical Sciences'}, 'officialTitle': 'Whole Brain Irradiation With Hippocampal Sparing for Brain Metastases From Breast Cancer: Neurocognitive Function and Prognosis Analysis', 'orgStudyIdInfo': {'id': 'ky-2016-9-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Whole-brain radiotherapy (WBRT) group', 'description': 'Conventional whole-brain radiotherapy for brain metastases from breast cancer with dose of 37.5 Gy in 15 fractions.', 'interventionNames': ['Radiation: whole brain radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Hippocampal-sparing WBRT (HS-WBRT) group', 'description': 'Hippocampal-sparing whole brain radiotherapy is performed using modern intensity-modulated radiotherapy (IMRT) technique to avoid conformally the hippocampal neural stem-cell structure during WBRT. Prescription dose is 37.5 Gy in 15 fractions.', 'interventionNames': ['Radiation: whole brain radiotherapy']}], 'interventions': [{'name': 'whole brain radiotherapy', 'type': 'RADIATION', 'armGroupLabels': ['Hippocampal-sparing WBRT (HS-WBRT) group', 'Whole-brain radiotherapy (WBRT) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng Jiang', 'role': 'CONTACT', 'email': 'keyan307@163.com', 'phone': '861066947017'}], 'facility': 'Affiliated Hospital of Academy of Military Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zheng Jiang', 'role': 'CONTACT', 'email': 'keyan307@163.com', 'phone': '861066947017'}], 'overallOfficials': [{'name': 'Bing Sun, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Academy of Military Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital to Academy of Military Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}