Stage IIIA Non-small Cell Lung Cancer
Conditions
Keywords
Neoadjuvant Treatment, Observational study, Resectable IIIA patients, Non small cell lung cancer, Pathological response
Brief summary
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
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.
Interventions
DRUGCisplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
DRUGCarboplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Sponsors
Fundación GECP
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | Types of histopathological changes within tumor bed: fibrosis, lymphoid aggregates and others |
| 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 | Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response. |
| 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 | 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. |
Countries
Spain
Contacts
CONTACTEva Pereira
STUDY_CHAIRMariano Provencio, MD
President of Grupo Español de Cáncer de Pulmón
Outcome results
None listed