Proton Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable, Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC): A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints high doses of radiation directly to cancer. Standard radiation (or photon radiation) is commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is a special type of radiation only available at a few institutions in the US and has not been previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.
In this study, the investigators are evaluating the safety and effectiveness of proton-based SBRT for early-stage NSCLC located in the periphery of the lung.
详细描述
Subjects will undergo an electronic navigational bronchoscopy (ENB) during which three markers will be placed around their tumor which will guide the delivery of proton beam radiation to their with more precision and accuracy.
Subjects will receive a CT scan to obtain images to plan radiation treatment. Proton radiation will be delivered daily (4 or 5 consecutive days) on an outpatient basis at Massachusetts General Hospital.
After the final dose of proton radiation subjects will be followed for 5 years. Subjects will be asked to return at 3 months, and then every 3 months until 2 years, and then every 6 months until 5 years. Subjects will receive a chest CT, tumor assessment by CT or PET, chest x-ray, pulmonary function tests and a physical exam.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed non-small cell lung cancer (need not be newly diagnosed)
- •Stage clinical T1 N0 M0 or T2 N0 M0
- •NSCLC must be limited to a single lesion
- •NSCLC must be peripherally located (> 2 cm from proximal bronchial tree and > 1 cm from mediastinal pleura)
- •NSCLC must be considered medically inoperable
- •Life expectancy greater than 6 months
排除标准
- •Pregnant or breastfeeding
- •Prior radiation therapy to the lungs or mediastinum
- •Prior malignancy in the last 2 years unless treated definitively and disease free or carcinoma in situ or early stage skin cancers that have been definitively treated
- •Receiving other study agents or other types of cancer therapy
- •Uncontrolled intercurrent illness
- •Pacemaker or defibrillator-dependent
结局指标
主要结局
Safety and tolerability
时间窗: 2 years
Frequency of radiation pneumonitis in participants treated with proton radiation
Feasibility and safety
时间窗: 2 years
To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)
次要结局
- Toxicity(2 years)
- Disease Free survival(2 years)
- Efficacy(2 years)
- Overall survival(2 years)
研究者
Henning Willers, M.D.
Attending Radiation Oncologist
Massachusetts General Hospital