Proton Stereotactic Body Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer
Proton Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable, Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC): A Pilot Study
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第一阶段早期
联系人和位置
学习地点
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-
Massachusetts
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Boston、Massachusetts、美国、02214
- Massachusetts General Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：SBRT with proton beam radiation
4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of > 3 cm)
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4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of > 3 cm)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility and safety
大体时间：2 years
|
To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)
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2 years
|
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Safety and tolerability
大体时间：2 years
|
Frequency of radiation pneumonitis in participants treated with proton radiation
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2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Toxicity
大体时间：2 years
|
Describe the acute and late toxicities of treatment using CTCAE v4.0
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2 years
|
|
Efficacy
大体时间：2 years
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To describe radiological tumor responses
|
2 years
|
|
Disease Free survival
大体时间：2 years
|
To calculate local, regional, and distant failure rates
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2 years
|
|
Overall survival
大体时间：2 years
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To calculate the overall survival rate
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2 years
|
合作者和调查者
调查人员
- 首席研究员：Henning Willers, M.D.、Massachusetts General Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.