Brain Metastasis, Radiation Therapy Complication
Conditions
Keywords
brain metastasis, whole-brain radiotherapy, TMZ, avoidance of hippocampus
Brief summary
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.
Detailed description
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.
Interventions
DRUGTMZ
TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
RADIATIONWBRT 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.
RADIATIONWBRT without avoidance of hippocampus
Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Primary lesions diagnosed by pathology or cytology * 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
* MMSE score \<27 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of neurocognitive function between baseline and 4 months after radiotherapy | baseline; four months after radiotherapy | Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on response rate | baseline; One, two, four, six, and twelve months after radiotherapy | Response is evaluated on basis of RECIST |
| The tolerance of radiotherapy with TMZ concurrent chemotherapy | baseline; once a week through during radiotherapy, up to 3 weeks | Adverse effects are evaluated by CTCAE 4.0 criteria |
Countries
China
Contacts
Primary ContactYun-fei Xia, Professor
Backup ContactXiaohui Wang, MD
Outcome results
None listed