Radiation Therapy in Combination With Indinavir / Ritonavir (Crixivan / Norvir) for the Treatment of Brain Metastases: a Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Time to treatment failure in the brain (TTF) as determined by the radiological response rate
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether external-beam radiation therapy is more effective with or without indinavir and ritonavir in treating patients with brain metastases.
PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to see how well it works compared to external-beam radiation therapy given together with indinavir and ritonavir in treating patients with brain metastases.
详细描述
OBJECTIVES:
- Compare the efficacy, in terms of time to treatment failure at CNS level and 4-months treatment failure rate, in patients with brain metastases treated with external-beam radiotherapy in combination with indinavir sulfate and ritonavir versus external-beam radiotherapy alone.
- Prospectively investigate the efficacy of a potentially antiangiogenic agent, indinavir sulfate.
- Investigate the antineoplastic activity of indinavir sulfate in combination with ionizing radiation in cancer patients with metastatic disease to the brain.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks (10 doses total). Patients also receive oral indinavir sulfate and oral ritonavir twice daily for 35 days beginning at day 1 of radiotherapy.
- Arm II: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks (10 doses total).
Patients complete quality of life questionnaires, including QOL-30 and the Mini Mental Status Examination, at baseline, 2 weeks after completion of radiotherapy, and at 1 and 3 months after completion of study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic cancer with brain metastases
- •Biopsy of brain metastases is not required
- •All cancer types allowed, except for the following:
- •Prostatic adenocarcinoma
- •Germ cell carcinoma,
- •Small-cell lung cancer
- •Measurable disease by MRI of the brain
- •Not requiring immediate surgical decompression (may qualify after surgery, if remaining measurable brain lesions)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2 (corresponds to recursive partitioning analysis groups I or II)
- •Life expectancy > 4 months
- •Able to understand the aim of trial and to comply with follow-up
- •No HIV seropositivity
- •PRIOR CONCURRENT THERAPY:
- •Prior dexamethasone allowed provided it is tapered before initiation of study radiotherapy
- •Not requiring cytotoxic treatment within 3 months after study radiotherapy
- •At least 1 week since prior and no concurrent phenytoin
排除标准
- 未提供
结局指标
主要结局
Time to treatment failure in the brain (TTF) as determined by the radiological response rate
Local intracranial disease progression at 4 months
Radiological volumetric response to treatment
Overall survival (OS)
Progression-free survival at 6 months
次要结局
- Duration of use of anticonvulsive drugs
- Time to symptom relapse or symptom progression
- Improvement of symptoms
- Duration of use of steroids