A Randomised Phase II Double Blind Placebo Controlled Trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Multiple Brain Metastases [TACTIC]
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Neurological progression-free survival at 2 months
研究概览
简要总结
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib may also make tumor cells more sensitive to radiation therapy. It is not yet known whether giving whole-brain radiation therapy together with erlotinib is more effective than whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and brain metastases.
PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and erlotinib to see how well they work compared with whole-brain radiation therapy alone in treating patients with advanced non-small cell lung cancer and brain metastases.
详细描述
OBJECTIVES:
Primary
- Compare the effect of whole-brain radiotherapy (WBRT) and erlotinib hydrochloride vs WBRT alone on neurological progression-free survival at 2 months in patients with advanced non-small cell lung cancer and multiple brain metastases.
Secondary
- Compare the toxicity of these regimens.
- Compare the response rate in these patients.
- Compare quality of life of these patients.
- Compare change in performance status in these patients.
- Compare steroid dosing in these patients.
- Compare sites of progression (cranial or extracranial) in these patients.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
erlotinib hydrochloride
WBRT plus Tarceva (OSI-774, erlotinib) PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months
干预措施: erlotinib hydrochloride (Drug)
placebo
WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride arm
干预措施: placebo (Drug)
结局指标
主要结局
Neurological progression-free survival at 2 months
时间窗: at 2 months
次要结局
- Toxicity(during and for 28 days following Tarceva/placebo treatment.)
- Response rate(from date of randomisation to radiological progression)
- Quality of life(completed monthly for the first 12 months and at 18 and 24 months from randomisation)
- Change in performance status(from baseline)
- Steroid dosing(from baseline)
- Sites of progression (cranial or extracranial)(from baseline)