Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- To assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.
研究概览
简要总结
This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms.
详细描述
This is a non-interventional, observational, multicenter and retrospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry (TTR) data base and the data from stage IIIA clinical trials case report forms, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.
The primary objective is to assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.
It is estimated that around 15-20 Spanish sites are enrolling patients with these characteristics in the TTR or in the stage IIIA clinical trials of the Fundación GECP.
Pathologists and physician's of these sites will be invited to participate in the PLANET study as all cases will be clinical-pathologically re-evaluated to reach the study objectives. Each pathologist will re-evaluate the specimens from the selected patients under common criteria.The sample size would be 150 patients enrolled in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients with resectable stage IIIA disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8) who were included in the Tumor Thoracic Registry data base and in stage IIIA clinical trials which the sponsor is Fundación GECP.
- •Patients with histologically N2 involvement confirmed
- •Patients diagnosed as stage IIIA from 2010 and 2017
- •Patients who have received neoadjuvant platinum-based treatment and surgery
- •Age ≥ 18 years at time of study entry
- •PET /TC at diagnosis
排除标准
- •Patients who received chemoradiotherapy neoadjuvant treatment
- •Patients who were not resected after neoadjuvant treatment
- •Patients who were diagnosed after June 2017
研究组 & 干预措施
Experimental: platinum-based neoadjuvant treatment and surgery.
Resectable stage IIIA non-small cell lung cancer patients treated with platinum-based neoadjuvant treatment and surgery.
干预措施: Cisplatin (Drug)
Experimental: platinum-based neoadjuvant treatment and surgery.
Resectable stage IIIA non-small cell lung cancer patients treated with platinum-based neoadjuvant treatment and surgery.
干预措施: Carboplatin (Drug)
结局指标
主要结局
To assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients.
时间窗: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response.
次要结局
- To describe the percentage of residual viable tumor in this population of patients under common criteria(From the end of neoadjuvant treatment until the last follow up or death,assessed up to 45 months)
- To describe the histopathological changes within tumor bed associated to tumor response(From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months)
- To describe the relation between nodal downstaging after neoadjuvant treatment and overall survival(From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months)
- To correlate pathological response and post-surgical complications(From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months)