Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer

University Health Network, Toronto1 个研究点分布在 1 个国家目标入组 12 人2018年10月3日

适应症Lung Cancer, Nonsmall Cell Lung Cancer

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Lung Cancer, Nonsmall Cell
发起方: University Health Network, Toronto
入组人数: 12
试验地点: 1
主要终点: Patient experience and anxiety related to Quality of Life
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2018年10月3日

结束日期

2027年9月1日

最后更新

上个月

研究类型

Observational

性别

All

研究者

发起方

University Health Network, Toronto

责任方

Sponsor

入排标准

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