Pathological Response After Neoadjuvant Treatment on NSCLC

NCT05167487 | Recruiting

• 1 other identifier: GECP 21/03_PLANET
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 17

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.

Conditions

Stage IIIA Non-small Cell Lung Cancer

Keywords

Neoadjuvant Treatment; Observational study; Resectable IIIA patients; Non small cell lung cancer; Pathological response

Outcome Measures

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.

  From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Experimental: platinum-based neoadjuvant treatment and surgery.

Resectable stage IIIA non-small cell lung cancer patients treated with platinum-based neoadjuvant treatment and surgery.

Drug: Cisplatin; Drug: Carboplatin

Interventions

Cisplatin DRUG

Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.

Also known as: Cis-diammine-dichloroplatinum, Platinol

Experimental: platinum-based neoadjuvant treatment and surgery.

Carboplatin DRUG

Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.

Also known as: Paraplatin

Experimental: platinum-based neoadjuvant treatment and surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who received chemoradiotherapy neoadjuvant treatment
• Patients who were not resected after neoadjuvant treatment
• Patients who were diagnosed after June 2017

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (17)

Hospital Universitario De A Coruna

A Coruña, A Coruña, 15006, Spain

RECRUITING

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

RECRUITING

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital Universitario Insular de Gran canaria

Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain

RECRUITING

Hospital Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital 12 De Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Hospital Universitario la Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario Regional de Málaga

Málaga, Málaga, 29010, Spain

RECRUITING

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, 36036, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Universitario Cruces

Barakaldo, Vizcaya, 48903, Spain

RECRUITING

Related Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Mariano Provencio, MD

  President of Grupo Español de Cáncer de Pulmón

  STUDY CHAIR

Central Study Contacts

Eva Pereira

CONTACT

+34934302006; gecp@gecp.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 22, 2021
• Study Start: December 13, 2021
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (17)