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| Name | Class |
|---|---|
| Fifth Affiliated Hospital, Sun Yat-Sen University | OTHER |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WBRT | Experimental | Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied. |
|
| WBRT with avoidance of hippocampus | Experimental | Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied. |
|
| WBRT with TMZ | Experimental | Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied. |
|
| WBRT with avoidance of hippocampus and TMZ | Experimental | Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus and concurrent TMZ chemotherapy applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMZ | Drug | TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of neurocognitive function between baseline and 4 months after radiotherapy | Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE) | baseline; four months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on response rate | Response is evaluated on basis of RECIST | baseline; One, two, four, six, and twelve months after radiotherapy |
| The tolerance of radiotherapy with TMZ concurrent chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun-fei Xia, Professor | Contact | 86-13602805461 | xiayf@sysucc.org.cn | |
| Xiaohui Wang, MD | Contact | 86-18826260661 | wangxh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yun-fei Xia, Professor | Department of Radiation Oncology, Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
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| WBRT with avoidance of hippocampus | Radiation | 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 | Radiation | Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered. |
|
Adverse effects are evaluated by CTCAE 4.0 criteria
| baseline; once a week through during radiotherapy, up to 3 weeks |
| Guangdong Three Nine Brain Hospital | Guangzhou | Guangdong | 510000 | China |
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| Guangzhou First People's Hospital | Guangzhou | Guangdong | 510000 | China |
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| Guangzhou People's Liberation Army Hospital 421 | Guangzhou | Guangdong | 510000 | China |
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| Panyu Central Hospital | Guangzhou | Guangdong | 510000 | China |
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| The First Affiliated Hospital, Jinan University | Guangzhou | Guangdong | 510000 | China |
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| The Affiliated Cancer Hospital Of Guangzhou Medical Collage | Guangzhou | Guangdong | 510095 | China |
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| Guangdong Provincial Hospital Of Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
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| The First Affiliated Hospital Of Guangzhou Medical Collage | Guangzhou | Guangdong | 510120 | China |
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| The Fifth Affiliated Hospital, Sun Yat-Sen University | Zhuhai | Guangdong | 519000 | China |
|
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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