A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC#66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Time to tumor progression
研究概览
简要总结
Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation therapy is more effective with or without thalidomide in treating brain metastases.
详细描述
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.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm I (radiation therapy)
Patients undergo radiotherapy once daily 5 days a week for 3 weeks.
干预措施: radiation therapy (Radiation)
Arm I (radiation therapy)
Patients undergo radiotherapy once daily 5 days a week for 3 weeks.
干预措施: quality-of-life assessment (Procedure)
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.
干预措施: radiation therapy (Radiation)
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.
干预措施: thalidomide (Drug)
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.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Time to tumor progression
时间窗: Date of randomization to documentation of progression, assessed up to 6 years
Cumulative incidence model will be used to analyze the data. A multivariate Cox model analysis will be performed.
Overall survival
时间窗: Up to 6 years
The log-rank statistic will be used.
Time to neuro-cognitive progression as assessed by the Mini Mental State Exam
时间窗: Up to 6 years
Cumulative incidence model will be used to analyze the data.
次要结局
- Frequency of toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0(Up to 6 years)
- Quality of life as measured by the SQLI(12 months)
- Cause of death distribution(Up to 6 years)
- Quality of life as measured by the Spitzer Quality of Life Index (SQLI)(6 months)