Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases
A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases
研究概览
详细说明
OBJECTIVES:
I. Compare the overall survival of patients with multiple brain metastases treated with radiotherapy with or without thalidomide.
II. Compare the time to tumor progression in patients treated with these regimens.
III. Compare the time to neuro-cognitive progression in patients treated with these regimens.
IV. Compare the cause of death distribution in patients treated with these regimens.
V. Compare the frequency of toxic effects of these regimens in these patients. VI. Evaluate and compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (I vs II) and planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo radiotherapy once daily 5 days a week for 3 weeks. Arm II: Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily.
Treatment with thalidomide continues for 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at completion of radiotherapy, and then every 2 months for 1 year.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study within 14.5 months.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19103
- Radiation Therapy Oncology Group
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically confirmed extracranial primary malignancy
- Multiple brain metastases
At least 1 measurable brain metastasis by MRI
- More than 4.0 cm
- Located in midbrain or brainstem (radiosurgery ineligible)
- Performance status - Zubrod 0-1
- At least 8 weeks
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 11 g/dL*
- Hematocrit at least 35%*
- Bilirubin no greater than 1.5 mg/dL
- ALT no greater than 2 times normal
- Creatinine no greater than 1.5 mg/dL
- BUN no greater than 25 mg/dL
- No history of deep venous thrombosis
- No sensory neuropathy grade 2 or greater
- No known AIDS
- No other major medical illness or psychiatric impairments that would preclude study therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier method of contraception during and for at least 4 weeks after study
- No prior thalidomide
- More than 2 weeks since prior chemotherapy
- Concurrent chemotherapy allowed if more than 6 weeks past study entry (allowed during first 6 weeks of study if disease progression occurs)
- See Disease Characteristics
- No prior radiotherapy to the head or neck
- No prior radiosurgery
- Prior resection of brain metastases allowed
- No concurrent anticoagulant therapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Arm I (radiation therapy)
Patients undergo radiotherapy once daily 5 days a week for 3 weeks.
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辅助研究
其他名称：
Undergo conventional radiation therapy
其他名称：
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实验性的：Arm II (radiation therapy, thalidomide)
Patients undergo radiotherapy as in arm I. Beginning on the first day of radiotherapy, patients receive oral thalidomide once daily.
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辅助研究
其他名称：
口头给予
其他名称：
Undergo conventional radiation therapy
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall survival
大体时间：Up to 6 years
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The log-rank statistic will be used.
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Up to 6 years
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Time to tumor progression
大体时间：Date of randomization to documentation of progression, assessed up to 6 years
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Cumulative incidence model will be used to analyze the data.
A multivariate Cox model analysis will be performed.
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Date of randomization to documentation of progression, assessed up to 6 years
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Time to neuro-cognitive progression as assessed by the Mini Mental State Exam
大体时间：Up to 6 years
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Cumulative incidence model will be used to analyze the data.
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Up to 6 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Cause of death distribution
大体时间：Up to 6 years
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Up to 6 years
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Frequency of toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
大体时间：Up to 6 years
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Up to 6 years
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Quality of life as measured by the Spitzer Quality of Life Index (SQLI)
大体时间：6 months
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6 months
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Quality of life as measured by the SQLI
大体时间：12 months
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12 months
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合作者和调查者
合作者
调查人员
- 首席研究员：Jonathan Knisely、Radiation Therapy Oncology Group
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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