Prospective Trial of Immunotherapy Prior to Resection, Definitive Chemo-radiotherapy, or Palliative Therapy in Patients With Locally Advanced or Oligometastatic Non-small Cell Lung Cancer Without a Primary Curative Option
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- patients completing definitive therapy
研究概览
简要总结
In a certified lung- cancer center, patients with NSCLC and a potentially curative stage (including patients with oligometastatic disease) are prospectively enrolled if curative treatment (either definitive radio-chemotherapy or resection) cannot be performed due to large tumor size or for functional reasons. For these patients, the multidisciplinary tumor board (MDB) recommends immuno-(chemo)therapy and re-evaluation. Response is assessed radiologically including PET-CT if indicated. After review of the MDB, patients receive either definitive curative treatment or palliative treatment.
详细描述
In a certified lung- cancer center, patients with NSCLC and a potentially curative stage (including patients with oligometastatic disease) are prospectively enrolled if curative treatment (either definitive radio-chemotherapy or resection) cannot be performed due to large tumor size or for functional reasons (e. g. too large radiation field or functionally inoperable for the required resection). For these patients, the multidisciplinary tumor board (MDB) recommends immuno-(chemo)therapy and re-evaluation. Response is assessed radiologically including PET-CT if indicated. After review of the MDB, patients receive either definitive curative treatment or palliative treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •newly diagnosed NSCLC
- •histologically or cytologically proven
- •stage III - IVA (oligometastatic) by complete staging
- •life expectancy 3 months
- •ability to provide written informed consent
排除标准
- •primary resectability
- •primary definitive chemoradiotherapy feasible
结局指标
主要结局
patients completing definitive therapy
时间窗: 1 year
proportion of patients completing definitive therapy
次要结局
- local downstaging(1 year)
- complete or partial radiologic response(1 year)
- complete metabolic response(1 year)
- overall survival (OS)(5 years)
- event-free survival (EFS)(5 years)
研究者
Martin Faehling
Head of Pneumology
Klinikum Esslingen
