NCT00875901已完成不适用
Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.
研究概览
简要总结
This is a research study to determine if hypofractionated image guided radiation therapy (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients who will not have surgery. HypoIGRT delivers higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to deliver a more lethal dose of radiation to the tumor and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Pathologically confirmed, by biopsy or cytology, non-small cell lung carcinoma diagnosed within 3 months prior to study enrollment.
- •T1, N0, M0 or T2, N0, M
- •(AJCC Lung 7th Edition)
- •At least 18 years old at the time of consent.
- •Adequate bone marrow function.
- •Medically inoperable. Medically operable candidates are allowed if they refuse surgical resection.
- •If the patient has a large pleural effusion, it must be biopsy negative.
排除标准
- •Evidence of distant metastasis (M1) and/or nodal involvement (N1, N2, N3).
- •Synchronous primary.
- •T2 tumors > 5 cm; T3, T4 primary tumor.
- •Previous radiotherapy for lung cancer.
- •Concomitant local, regional, and/or systemic therapy during radiotherapy.
- •Active systemic, pulmonary, and/or pericardial infection.
结局指标
主要结局
Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.
时间窗: 1 year after the end of radiation therapy
次要结局
- Collect and analyze outcome data on tumor control and survival(When each patient has been followed for a minimum of 12 months to a maximum of 5 years)
- Assess differences in dosimetric values compared with photons for lung, heart, esophagus, spinal cord, skin and brachial plexus(When each patient has been followed for a minimum of 12 months to a maximum of 5 years)
- Assess changes in quality of life before and after treatment(Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years)
研究者
研究点 (2)
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