NCT03705806进行中（未招募）不适用
Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Patient experience and anxiety related to Quality of Life
研究概览
简要总结
The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment.
- •Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10).
- •Receiving or planned to receive nivolumab or pembrolizumab
- •Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks
- •Age 18 or older
- •ECOG Performance Status 0-2
- •Life expectancy greater than 3 months
- •Able and willing to provide informed consent
- •Able to complete patient reported outcome questionnaires
排除标准
- •Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia
- •Previous history of thoracic radiotherapy with an overlapping field
- •Previous history of checkpoint inhibitor related pneumonitis or esophagitis
结局指标
主要结局
Patient experience and anxiety related to Quality of Life
时间窗: up to 12 months
EQ-5D
Rate of Radiation related toxicities
时间窗: up to 24 months
rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading
Patient Report Outcome
时间窗: up to 12 months
FACT-E
次要结局
- Rate of Survival(2 year)
- Rate of Disease Recurrence(3, 6, 12 months)
- Rate of Survival(1 year)
研究者
研究点 (1)
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