Pathological Response After Neoadjuvant Treatment on NSCLC
NCT ID: NCT05167487
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2021-12-13
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Experimental: platinum-based neoadjuvant treatment and surgery.
Resectable stage IIIA non-small cell lung cancer patients treated with platinum-based neoadjuvant treatment and surgery.
Cisplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Carboplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Interventions
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Cisplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Carboplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 were not resected after neoadjuvant treatment
* Patients who were diagnosed after June 2017
18 Years
ALL
No
Sponsors
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Fundación GECP
OTHER
Responsible Party
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Principal Investigators
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Mariano Provencio, MD
Role: STUDY_CHAIR
President of Grupo Español de Cáncer de Pulmón
Locations
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Hospital Universitario De A Coruna
A Coruña, A Coruña, Spain
Hospital General Universitario de Alicante
Alicante, Alicante, Spain
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital 12 De Octubre
Madrid, Madrid, Spain
Hospital Universitario la Paz
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Regional de Málaga
Málaga, Málaga, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain
Hospital Universitario La Fe
Valencia, Valencia, Spain
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain
Countries
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Central Contacts
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Facility Contacts
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Teresa Hermida, MD
Role: primary
Ignacio Aranda, MD
Role: primary
José Luis Mate, MD
Role: primary
Irene Sansano, MD
Role: primary
Laura López Vilaró, MD
Role: primary
Nuria Baixeras, MD
Role: primary
Maria del Carmen Camacho, MD
Role: primary
María Luz Plaza, MD
Role: primary
Melchor Saiz Pardo, MD
Role: primary
Federico Rojo, MD
Role: primary
Ana Belén Enguita, MD
Role: primary
Isabel Esteban, MD
Role: primary
Mariano Provencio, MD
Role: primary
Pino Flores, MD
Role: primary
Ana González, MD
Role: primary
Nuria Mancheño, MD
Role: primary
Mónica Saiz, MD
Role: primary
Related Links
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Web page of the sponsor where users can find more information about Fundación GECP studies
Other Identifiers
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GECP 21/03_PLANET
Identifier Type: -
Identifier Source: org_study_id
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