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临床试验/NCT04926584
NCT04926584招募中不适用

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

Klinikum Esslingen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年12月15日最近更新:
适应症

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

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

发起方
Klinikum Esslingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Faehling

Head of Pneumology

Klinikum Esslingen

研究点 (1)

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