NCT00031967已完成2 期
A Randomized Phase II Study of A.M. and P.M. Melatonin for Brain Metastasis in RPA Class II Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 234
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as melatonin may make tumor cells more sensitive to radiation therapy and may protect normal cells from the side effects of radiation therapy.
PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with radiation therapy in treating patients who have brain metastases.
详细描述
OBJECTIVES:
- Determine the effect of melatonin, used as radiosensitization/radioprotection, on overall survival and clinical deterioration in patients with brain metastases who are undergoing radiotherapy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo whole brain irradiation once daily 5 days a week for 2 weeks. Patients receive oral melatonin once daily every morning.
- Arm II: Patients undergo whole brain irradiation as in arm I. Patients receive oral melatonin once daily every evening.
All patients continue on melatonin for 6 months in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 0 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumor with brain metastasis
- •No germ cell tumors
- •RPA class II with any of the following:
- •At least 65 years of age
- •Extracranial metastases
- •Uncontrolled primary malignancy
- •Ineligible for or unwilling to participate in alternative RTOG stereotactic radiosurgery studies
- •PATIENT CHARACTERISTICS:
- •See Disease Characteristics
- •Performance status:
- •Zubrod 0-1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Able to swallow pills
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •More than 30 days since prior chemotherapy
- •Concurrent chemotherapy after whole brain irradiation allowed
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy to the brain
- •Not specified
排除标准
- 未提供
研究者
研究点 (234)
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