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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 256
- 试验地点
- 10
- 主要终点
- Change of neurocognitive function between baseline and 4 months after radiotherapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
WBRT
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy without avoidance of hippocampus applied.
干预措施: WBRT without avoidance of hippocampus (Radiation)
WBRT with avoidance of hippocampus
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with avoidance of hippocampus applied.
干预措施: WBRT with avoidance of hippocampus (Radiation)
WBRT with TMZ
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.
干预措施: TMZ (Drug)
WBRT with TMZ
Patients with brain metastases (>3 lesions) ; Whole-brain radiotherapy with concurrent TMZ chemotherapy applied.
干预措施: WBRT without avoidance of hippocampus (Radiation)
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.
干预措施: TMZ (Drug)
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.
干预措施: WBRT with avoidance of hippocampus (Radiation)
结局指标
主要结局
Change of neurocognitive function between baseline and 4 months after radiotherapy
时间窗: baseline; four months after radiotherapy
Neurocognitive function is evaluated by Minimum Mental State Examination (MMSE)
次要结局
- The tolerance of radiotherapy with TMZ concurrent chemotherapy(baseline; once a week through during radiotherapy, up to 3 weeks)
- Effect on response rate(baseline; One, two, four, six, and twelve months after radiotherapy)
研究者
Yun-fei Xia
Director of Department of Radiation Oncology, Principal Investigator, Clinical Professor
Sun Yat-sen University