NCT00005887已完成3 期
A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 73
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.
详细描述
OBJECTIVES:
- Compare the median survival time in patients with brain metastases after receiving treatment with whole brain radiotherapy with or without RSR13.
- Compare the response rate to these treatment regimens in these patients.
- Compare the time to progression after receiving these treatment regimens in these patients.
- Compare quality of life in these patients receiving these treatment regimens.
- Compare cause of death (neurologic vs nonneurologic death) in these patients after receiving these treatment regimens.
- Determine the safety of RSR13 in these patients.
- Assess the pharmacokinetics of RSR13 in these patients.
OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients are further stratified within the RPA class II stratum according to site of primary cancer (non-small cell lung cancer vs breast vs other). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive whole brain radiotherapy 5 days a week for two weeks in conjunction with supplemental oxygen breathing.
- Arm II: Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy and supplemental oxygen breathing as in arm I.
Quality of life is assessed at the first and last day of radiotherapy, at 1 month, 3 months, and then every 3 months until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following:
- •Small cell lung cancer, germ cell tumors, and lymphomas
- •No leptomeningeal metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •WBC at least 2,000/mm3
- •Platelet count at least 75,000/mm3
- •Bilirubin no greater than 2.0 mg/dL
- •ALT and AST no greater than 3 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL
- •Forced vital capacity and forced expiratory volume at least 50% of normal in patients with significant intrathoracic tumor involvement, chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary embolism
- •Resting and exercise oxygen saturation at least 90% on room air
- •No other concurrent active malignancy from a second histologic site
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy or immunotherapy for brain metastases
- •At least 28 days since prior investigational biologic therapy
- •Chemotherapy:
- •No prior chemotherapy for brain metastases
- •No chemotherapy for brain metastases for at least one month following radiation therapy
- •At least 7 days since prior chemotherapy for primary tumor or extracranial metastases
- •No planned chemotherapy during radiation therapy
- •Endocrine therapy:
- •No prior hormonal therapy for brain metastases
- •Prior or concurrent corticosteroid therapy allowed
- •Radiotherapy:
- •No prior whole brain radiotherapy for brain metastases
- •No prior stereotactic radiosurgery for brain metastases
- •Prior surgery allowed for brain metastases if at least one measurable lesion remains
- •At least 28 days since prior investigational drug or device
- •No prior RSR13
排除标准
- 未提供
研究者
研究点 (73)
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