A Phase II Trial of 3 Dimensional Proton Radiotherapy With Concomitant Chemotherapy for Patients With Initially Unresectable Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities
研究概览
简要总结
The purpose of this study is to find out what effects, good and/or bad, proton radiation at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the standard dose. This may be able to increase the control of the tumor. Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard. This may be able to reduce the frequency and severity of the usual radiation side effects.
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
- •Histologically or cytologically documented non-small cell carcinoma of the lung diagnosed within 16 weeks prior to study enrollment.
- •Patient must be at least 18 years old at the time of consent.
- •Stage III A or III B disease.
- •Patients must be able to start study treatment within 6 weeks of study enrollment.
- •Induction chemotherapy is allowed.
- •Marginally resectable or unresectable at presentation.
- •If the patient had exploratory thoracotomy, it must be done at least 3 weeks prior to enrollment.
排除标准
- •Evidence of distant metastasis.
- •Prior thoracic radiotherapy.
- •Any history of allergic reaction to taxanes.
- •Prior tumor resection. Candidate for upfront curative surgery.
- •Pleural effusion visible on chest x-ray or the scout view of the CT chest.
- •Unintentional weight loss within the month prior to diagnosis ≥ 10%.
- •Previous or concomitant malignancy other than early stage tumor treated more than 3 years ago for cure.
- •The presence of PET positive contralateral hilar disease.
研究组 & 干预措施
PET positive nodal disease measuring 15 mm or greater
Proton radiation with concomitant chemotherapy
干预措施: PET positive nodal disease measuring 15 mm or greater (Radiation)
PET positive nodal disease measuring less than 15 mm
Proton radiation
干预措施: PET positive nodal disease measuring less than 15 mm (Radiation)
Patients considered resectable
Proton radiation plus surgery
干预措施: Patients considered resectable (Radiation)
结局指标
主要结局
Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities
时间窗: Six months after end of radiation therapy
次要结局
- Percentage of Patients With Disease Control(Following treatment every 6 months for 2 years, then annually for 4 years.)
- Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy(Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually)
- Correlation of Functional CT-PET Imaging With Treatment Outcomes(Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years)
- Percentage of Patients Alive at 5 Years(Five years following radiation treatment)