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.
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.
Study Type
OBSERVATIONAL
Enrollment
150
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Hospital Universitario De A Coruna
A Coruña, A Coruña, Spain
RECRUITINGTo 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 months
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 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
Time frame: 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.
Time frame: 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.
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Hospital General Universitario de Alicante
Alicante, Alicante, Spain
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGHospital Vall d'Hebron
Barcelona, Barcelona, Spain
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGHospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, Spain
RECRUITINGHospital Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
RECRUITINGHospital Clínico San Carlos
Madrid, Madrid, Spain
RECRUITINGHospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
RECRUITING...and 7 more locations
Time frame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months