Phase I Dose Escalation Study of Accelerated Fractionation With Esophageal Sparing Using Intensity-Modulated Radiation Therapy for Locally-Advanced Thoracic Malignancies Including a Prospective Assessment of Esophageal Motion and Radiation-Induced Esophageal Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD) of IMRT
研究概览
简要总结
Hypothesis 1- Using IMRT, the radiation therapy (RT) dose can be safely escalated from 58 Gy to 74 Gy given as 6 fractions/week with concurrent chemotherapy.
Hypothesis 2- Esophageal motion can be used to customize planning organ at risk volumes.
Hypothesis 3- Biological predictors of acute esophagitis can be used to identify patients at high risk of developing esophageal toxicity from radiation therapy and chemotherapy.
详细描述
Prospective phase I study designed to determine the maximum tolerated dose of radiation therapy given in an accelerated fashion (2 Gy/fraction, 6 fractions/week) with concurrent chemotherapy. Intensity-modulated radiation therapy (IMRT) will be utilized to spare the esophagus. All patients on the dose escalation study will participate in additional assessments evaluating esophageal motion and esophageal toxicity from radiation therapy.
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
- •Histologic documentation of one of the following thoracic malignancies:
- •Non-small cell lung cancer (stage III or X (recurrent) with disease confined to local/regional sites)
- •Small cell lung cancer (stage II-III)
- •Thymoma (unresectable)
- •Thymic carcinoma (unresectable)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Weight loss < 10% in preceding 3 months prior to diagnosis
- •ANC > or = 1500 and platelet count > or = 100,
- •Creatinine clearance greater than 50 ml/min
- •18 years of age or older.
- •Negative pregnancy test in women of child-bearing potential
排除标准
- •Prior thoracic irradiation
- •Medical contraindications to thoracic irradiation
结局指标
主要结局
Maximum tolerated dose (MTD) of IMRT
时间窗: within 30 days of completing RT
次要结局
- The occurrence of RT-induced acute esophagitis(One year)
- To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy(Two years)