A Clinical Trial on Whole-brain Radiotherapy With Temozolomide Concurrent Chemotherapy or Avoidance of Hippocampus for Patients of Brain Metastases
NCT ID: NCT02832635
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
256 participants
INTERVENTIONAL
2016-07-31
2017-12-31
Brief Summary
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Detailed Description
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The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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WBRT
Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.
WBRT without avoidance of hippocampus
Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.
WBRT with avoidance of hippocampus
Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.
WBRT with avoidance of hippocampus
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.
WBRT with TMZ
Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.
TMZ
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
WBRT without avoidance of hippocampus
Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.
WBRT with avoidance of hippocampus and TMZ
Patients with brain metastases (\>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied.
TMZ
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
WBRT with avoidance of hippocampus
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.
Interventions
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TMZ
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
WBRT with avoidance of hippocampus
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.
WBRT without avoidance of hippocampus
Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Brain metastases confirmed by brain MRI or CT(\>3 brain metastases）
* Brain metastases beyond 5mm of hippocampus
* Male or female patients with age between 18 and 75 years old
* Karnofsky Performance Scores ≥ 60
* Expected survival ≥ 6 months
* No previous brain surgery or brain radiotherapy
* Without dysfunction of heart, lung, liver, kidney and hematopoiesis
* The primary carcinoma is under control
Exclusion Criteria
* Dysfunction of heart, lung, liver, kidney or hematopoiesis
* Severe neurological, mental or endocrine diseases
* History of alcohol or drug abuse within 3 months
* Visual or hearing dysfunction, low education level, or other reasons leading to not capable of taking the MMSE test
* Currently under treatment may effect patients' neurocognitive functions
* Patients participated in clinical trials of other drugs within last 3 months
* Other unsuitable reason
18 Years
75 Years
ALL
No
Sponsors
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Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Yun-fei Xia
Director of Department of Radiation Oncology, Principal Investigator, Clinical Professor
Principal Investigators
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Yun-fei Xia, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Locations
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Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Three Nine Brain Hospital
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Guangzhou People's Liberation Army Hospital 421
Guangzhou, Guangdong, China
Panyu Central Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Jinan University
Guangzhou, Guangdong, China
The Affiliated Cancer Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, China
Guangdong Provincial Hospital Of Chinese Medicine
Guangzhou, Guangdong, China
The First Affiliated Hospital Of Guangzhou Medical Collage
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital, Sun Yat-Sen University
Zhuhai, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Lin-bo Cai, Prof.
Role: primary
Guo-long Liu, Prof.
Role: primary
Si-Lang Zhou, Prof.
Role: primary
Xiao-long Cao, Prof.
Role: primary
Yi-ou Wang, Prof.
Role: primary
Zhibin Cheng, Professor
Role: primary
Other Identifiers
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B2016-005-01
Identifier Type: -
Identifier Source: org_study_id
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