Pathological Response After Neoadjuvant Treatment on NSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación GECP
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients who received chemoradiotherapy neoadjuvant treatment
Patients who were not resected after neoadjuvant treatment
Patients who were diagnosed after June 2017
Trial population
The study will include all resectable stage IIIA patients who have received platinum-based neoadjuvant treatment and surgery and that were diagnosed as stage IIIA from 2010 to 2017.The cohort of patients identified for the current study will be based on a portion of patients included in the Thoracic Tumor Registry (TTR) and in stage IIIA clinical trials approved by Spanish Health Authorities which the sponsor is Fundación GECP.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Cisplatin
DrugRoute of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Carboplatin
DrugRoute of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Experimental: platinum-based neoadjuvant treatment and surgery.2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 monthsSecondary outcomes
1
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
Time frame
From the end of neoadjuvant treatment until the last follow up or death,assessed up to 45 months2
To describe the histopathological changes within tumor bed associated to tumor response
Types of histopathological changes within tumor bed: fibrosis, lymphoid aggregates and others
Time frame
From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months3
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.
Time frame
From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months4
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.
Time frame
From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 monthsSponsors and contacts
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Source ClinicalTrials.gov