A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 7
- 主要终点
- Esophageal Quality of Life
研究概览
简要总结
A randomized phase II study of palliative radiation of advanced central lung tumors with intentional avoidance of the esophagus. Patients will be randomized between standard of care palliative thoracic radiation and esophageal-sparing intensity-modulated radiation therapy (ES-IMRT) in a 1:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 1 year after completion of their radiation therapy. The primary endpoint is esophageal quality of life as measured by the Esophageal Cancer Subscore (ECS) of the Functional Assessment of Cancer Therapy-Esophagus (FACT-E).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •American Joint Committee on Cancer (AJCC) 7th edition stage IV NSCLC or stage III not eligible for curative intent treatment
- •Intended to receive palliative radiotherapy to the thorax, to a dose of 30Gy in 10 fractions or 20Gy in 5 fractions. In either treatment arm at least 5cm of the esophagus should be in the intended treatment field.
- •Willingness and ability to provide informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •Age 18 years or older
- •Prior or planned systemic therapy (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist, provided that no systemic treatment is given within 2 weeks prior to RT, concurrent with RT or within a 2-week period post RT.
- •Concurrent palliative RT to other metastatic sites is permissible
- •Life expectancy > 3 months
排除标准
- •Prior thoracic RT
- •Serious medical comorbidities precluding RT
- •Pregnant or lactating women
- •Inability to attend the full course of RT or planned follow-up visits
- •Planned concurrent palliative RT to the stomach and/or liver
- •Congenital abnormalities of the esophagus or severe disorders of the esophagus (e.g. achalasia)
研究组 & 干预措施
Standard Palliative Radiation
Patients in the standard arm will receive a conventional radiotherapy dose will be either 30 gray (Gy) in 10 fraction or 20Gy in 5 fractions. Patients will be stratified by intended dose prior to randomization. Radiation for patients in the standard arm should adhere to the principles of palliative radiation, with goals of alleviating symptoms or preventing potential complications.
干预措施: Conventional radiotherapy (Radiation)
Esophageal Sparing IMRT
Patients on the experimental arm will receive esophageal-sparing intensity-modulated radiotherapy, with the same dose(s) as in the standard arm.
干预措施: Esophageal-Sparing Intensity-Modulated Radiotherapy (Radiation)
结局指标
主要结局
Esophageal Quality of Life
时间窗: 2 weeks after completion of radiotherapy
Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks.
次要结局
- Further Systemic Therapy(6 months after completion of radiotherapy)
- Dosimetry Comparison - Gross Tumor Volume (GTV)(6 months after completion of radiotherapy)
- Survival(6 months after completion of radiotherapy)
- Dosimetry Comparison - Pulmonary Metrics(6 months after completion of radiotherapy)
- Toxicity Rate Differences(6 months after completion of radiotherapy)
- Dosimetry Comparison - Esophageal Metrics(6 months after completion of radiotherapy)
- Progression-Free Survival(6 months after completion of radiotherapy)
- Cost-Effectiveness/Utility Analysis(6 months after completion of radiotherapy)
- Dosimetry Comparison - Planning Target Volume (PTV)(6 months after completion of radiotherapy)
研究者
Alexander Louie
Radiation Oncologist
Lawson Health Research Institute