Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-03-05 @ 3:14 PM
Study NCT ID:
NCT02832635
Status:
UNKNOWN
Last Update Posted:
2016-07-14
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain 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'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of neurocognitive function between baseline and 4 months after radiotherapy', 'timeFrame': 'baseline; four months after radiotherapy', 'description': 'Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)'}], 'secondaryOutcomes': [{'measure': 'Effect on response rate', 'timeFrame': 'baseline; One, two, four, six, and twelve months after radiotherapy', 'description': 'Response is evaluated on basis of RECIST'}, {'measure': 'The tolerance of radiotherapy with TMZ concurrent chemotherapy', 'timeFrame': 'baseline; once a week through during radiotherapy, up to 3 weeks', 'description': 'Adverse effects are evaluated by CTCAE 4.0 criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['brain metastasis', 'whole-brain radiotherapy', 'TMZ', 'avoidance of hippocampus'], 'conditions': ['Brain Metastasis', 'Radiation Therapy Complication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy (WBRT) with/without TMZ concurrent chemotherapy or avoidance of hippocampus for patients of brain metastases, as well as the feasibility and risk of avoidance of hippocampus during whole-brain radiotherapy.', 'detailedDescription': 'This is a phase II randomized clinical trial. It is reported that avoidance of hippocampus during whole-brain radiotherapy (WBRT) had benefits in preservation of memory for patients, and the use of concurrent TMZ in radiotherapy for patients with brain metastases benefited for treating outcome.\n\nThe purpose of this study is to evaluate the effects on neurocognitive function of whole-brain radiotherapy with/without TMZ concurrent chemotherapy or avoidance of hippocampus for patients of brain metastases, as well as the feasibility and risk of avoidance of hippocampus during whole-brain radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary lesions diagnosed by pathology or cytology\n* Brain metastases confirmed by brain MRI or CT(\\>3 brain metastases）\n* Brain metastases beyond 5mm of hippocampus\n* Male or female patients with age between 18 and 75 years old\n* Karnofsky Performance Scores ≥ 60\n* Expected survival ≥ 6 months\n* No previous brain surgery or brain radiotherapy\n* Without dysfunction of heart, lung, liver, kidney and hematopoiesis\n* The primary carcinoma is under control\n\nExclusion Criteria:\n\n* MMSE score \\<27\n* Dysfunction of heart, lung, liver, kidney or hematopoiesis\n* Severe neurological, mental or endocrine diseases\n* History of alcohol or drug abuse within 3 months\n* Visual or hearing dysfunction, low education level, or other reasons leading to not capable of taking the MMSE test\n* Currently under treatment may effect patients' neurocognitive functions\n* Patients participated in clinical trials of other drugs within last 3 months\n* Other unsuitable reason"}, 'identificationModule': {'nctId': 'NCT02832635', 'briefTitle': 'A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Effectiveness and Safety of Whole-brain Radiotherapy With/Without TMZ Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases: a Multi-institutional, Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'B2016-005-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WBRT', 'description': 'Patients with brain metastases (\\>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.', 'interventionNames': ['Radiation: WBRT without avoidance of hippocampus']}, {'type': 'EXPERIMENTAL', 'label': 'WBRT with avoidance of hippocampus', 'description': 'Patients with brain metastases (\\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.', 'interventionNames': ['Radiation: WBRT with avoidance of hippocampus']}, {'type': 'EXPERIMENTAL', 'label': 'WBRT with TMZ', 'description': 'Patients with brain metastases (\\>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.', 'interventionNames': ['Drug: TMZ', 'Radiation: WBRT without avoidance of hippocampus']}, {'type': 'EXPERIMENTAL', 'label': 'WBRT with avoidance of hippocampus and TMZ', 'description': 'Patients with brain metastases (\\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied.', 'interventionNames': ['Drug: TMZ', 'Radiation: WBRT with avoidance of hippocampus']}], 'interventions': [{'name': 'TMZ', 'type': 'DRUG', 'otherNames': ['temozolomide'], 'description': 'TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy', 'armGroupLabels': ['WBRT with TMZ', 'WBRT with avoidance of hippocampus and TMZ']}, {'name': 'WBRT with avoidance of hippocampus', 'type': 'RADIATION', 'description': 'Whole brain radiotherapy of 30Gy/10f by IMRT (Intensity Modulation Radiated Therapy), with or without boost. The maximum dose of hippocampus should be no more than 18Gy.', 'armGroupLabels': ['WBRT with avoidance of hippocampus', 'WBRT with avoidance of hippocampus and TMZ']}, {'name': 'WBRT without avoidance of hippocampus', 'type': 'RADIATION', 'description': 'Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.', 'armGroupLabels': ['WBRT', 'WBRT with TMZ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Yun-fei Xia, Professor', 'role': 'CONTACT', 'email': 'xiayf@sysucc.org.cn', 'phone': '86-13602805461'}, {'name': 'Xiaohui Wang, MD', 'role': 'CONTACT', 'email': 'wangxh@sysucc.org.cn', 'phone': '86-18826260661'}, {'name': 'Yun-fei Xia, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaohui Wang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Radiation Oncology, Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Lin-bo Cai, Prof.', 'role': 'CONTACT', 'phone': '86-13503030491'}, {'name': 'Linbo Cai, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangdong Three Nine Brain Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Guo-long Liu, Prof.', 'role': 'CONTACT', 'phone': '86-13802527172'}, {'name': 'Guo-long Liu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guangzhou First People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Si-Lang Zhou, Prof.', 'role': 'CONTACT', 'phone': '86-13189099597'}, {'name': 'Si-Lang Zhou, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guangzhou People's Liberation Army Hospital 421", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Xiao-long Cao, Prof.', 'role': 'CONTACT', 'phone': '86-18922238053'}, {'name': 'Xiao-long Cao, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Panyu Central Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Yi-ou Wang, Prof.', 'role': 'CONTACT', 'phone': '86-13602751067'}, {'name': 'Yi-ou Wang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital, Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510095', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Xun-fan Shao, Prof.', 'role': 'CONTACT', 'email': 'xunfanshao@yahoo.com.cn', 'phone': '+86-13902770926'}, {'name': 'Xun-fan Shao, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Affiliated Cancer Hospital Of Guangzhou Medical Collage', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Gong Li, Prof.', 'role': 'CONTACT', 'email': 'leegong@21cn.com', 'phone': '+86-13802915171'}, {'name': 'Gong Li, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangdong Provincial Hospital Of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Dao-li Niu, Prof.', 'role': 'CONTACT', 'email': 'daoliniu@163.com', 'phone': '+86-13711101855'}, {'name': 'Dao-li Niu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital Of Guangzhou Medical Collage', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '519000', 'city': 'Zhuhai', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Zhibin Cheng, Professor', 'role': 'CONTACT', 'phone': '86-13926946708'}, {'name': 'Zhibin Cheng, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Fifth Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}], 'centralContacts': [{'name': 'Yun-fei Xia, Professor', 'role': 'CONTACT', 'email': 'xiayf@sysucc.org.cn', 'phone': '86-13602805461'}, {'name': 'Xiaohui Wang, MD', 'role': 'CONTACT', 'email': 'wangxh@sysucc.org.cn', 'phone': '86-18826260661'}], 'overallOfficials': [{'name': 'Yun-fei Xia, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Sun Yat-Sen University Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fifth Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Radiation Oncology, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Yun-fei Xia', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}