Clinical trial NCT05167487: Pathological Response After Neoadjuvant Treatment on NSCLC
Official title: Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stage IIIA Non-small Cell Lung Cancer
Keywords: Neoadjuvant Treatment
Observational study
Resectable IIIA patients
Non small cell lung cancer
Pathological response
Lead sponsor: Fundación GECP
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
Secondary outcomes:
measure: To describe the percentage of residual viable tumor in this population of patients under common criteria
timeFrame: From the end of neoadjuvant treatment until the last follow up or death,assessed up to 45 months
measure: To describe the histopathological changes within tumor bed associated to tumor response
timeFrame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
measure: To correlate pathological response and post-surgical complications
timeFrame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
measure: To describe the relation between nodal downstaging after neoadjuvant treatment and overall survival
timeFrame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: ICO Badalona, Hospital Germans Trias i Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: ICO Hospitalet
state: Barcelona
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran canaria
state: Gran Canaria
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Dr. Negrín
state: Las Palmas
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
state: Pontevedra
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Vizcaya
city: A Coruña
country: Spain
facility: Hospital Universitario De A Coruna
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital 12 De Octubre
city: Madrid
country: Spain
facility: Hospital Universitario la Paz
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Málaga
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: President of Grupo Español de Cáncer de Pulmón
name: Mariano Provencio, MD
role: STUDY_CHAIR
References: