NCT00986297已完成1 期
Phase 1 Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-IV Non-Small Cell Lung Cancer and Poor Performance Status
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of specialized radiation therapy in treating patients with stage II, stage III, stage IV, or recurrent non-small cell lung cancer and poor performance status.
详细描述
OBJECTIVES:
Primary
- To escalate the dose of accelerated hypofractionated image-guided conformal radiotherapy to a potent tumoricidal dose without exceeding the maximum-tolerated dose in patients with recurrent or stage II-IV non-small cell lung cancer and poor performance status.
Secondary
- To evaluate local regional tumor control and overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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:
- •Histologically or cytologically confirmed non-small cell lung cancer
- •Stage II-IV and/or recurrent disease
- •No small cell histology
- •Measurable or evaluable disease
- •Tumor not amenable to surgical resection
- •Tumor not eligible for stereotactic body radiation therapy
- •No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 2-4
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must agree to use effective contraception
- •Must complete all required pretreatment evaluations
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 1 week since prior chemotherapy or chemoradiation therapy
- •No concurrent chemotherapy
- •No other concurrent antineoplastic therapy (including standard-fractionated radiotherapy to the chest, chemotherapy, biological therapy, vaccine therapy, and surgery) 1 week before, during, and for 1 week after completion of study therapy
排除标准
- 未提供
研究组 & 干预措施
arm one
Other
IGRT
干预措施: hypofractionated radiation therapy (Radiation)
结局指标
主要结局
Dose-limiting toxicity
时间窗: 90 days
次要结局
- Local regional tumor control(6 month)
- Overall survival(2 year)
研究者
研究点 (2)
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