Pathological Response After Neoadjuvant Treatment on NSCLC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes

Conditions
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Stage IIIA Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients who received chemoradiotherapy neoadjuvant treatment Patients who were not resected after neoadjuvant treatment Patients who were diagnosed after June 2017

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platinum-based neoadjuvant treatment and surgery.<br>Resectable stage IIIA non-small cell lung cancer patients treated with platinum-based neoadjuvant treatment and surgery. | Drug: Cisplatin<br>* Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.<br>* Other names: Platinol;Drug: Carboplatin<br>* Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.<br>* Other names: Paraplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response. | From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the percentage of residual viable tumor in this population of patients under common criteria | A) No response or more than 70% of viable tumor: Lymph node major pathological response negative (LN-MPR)- B) ≤70% of viable tumor cells: Lymph node major pathological response positive (LN-MPR)+ C) No evidence of any viable tumor (including primary tumor): Complete pathological response | 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 | Types of histopathological changes within tumor bed: fibrosis, lymphoid aggregates and others | 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 | Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological 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 | Downstaging after surgery is a reduction in the stage of a cancer. Overall Survival defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive. | From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoadjuvant Treatment, Observational study, Resectable IIIA patients, Non small cell lung cancer, Pathological response