Evaluating the response to neoadjuvant treatment in stage IIIA lung cancer patients
Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes
Fundación GECP · NCT05167487
This study is trying to see how well neoadjuvant treatment works for people with stage IIIA lung cancer by looking at their tissue samples to understand if it helps them live longer and stay cancer-free.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación GECP (other) |
| Locations | 17 sites (A Coruña, A Coruña and 16 other locations) |
| Trial ID | NCT05167487 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the pathological response in patients with resectable stage IIIA non-small cell lung cancer (NSCLC) after receiving neoadjuvant treatment. It will utilize data collected from the Tumor Thoracic Registry and clinical trial case report forms without interfering in standard clinical practices. The study will involve re-evaluating specimens from approximately 150 patients across multiple Spanish sites to determine the correlation between pathological response and overall survival as well as disease-free survival.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed resectable stage IIIA NSCLC who have received neoadjuvant platinum-based treatment.
Not a fit: Patients who received chemoradiotherapy as neoadjuvant treatment or were not resected after treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of neoadjuvant treatments, potentially improving treatment strategies for patients with stage IIIA NSCLC.
How similar studies have performed: Other studies have shown success in evaluating pathological responses in lung cancer, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
A Coruña, A Coruña and 16 other locations
- Hospital Universitario De A Coruna — A Coruña, A Coruña, Spain (RECRUITING)
- Hospital General Universitario de Alicante — Alicante, Alicante, Spain (RECRUITING)
- ICO Badalona, Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain (RECRUITING)
- Hospital Vall d'Hebron — Barcelona, Barcelona, Spain (RECRUITING)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (RECRUITING)
- ICO Hospitalet — L'Hospitalet de Llobregat, Barcelona, Spain (RECRUITING)
- Hospital Universitario Insular de Gran canaria — Las Palmas de Gran Canaria, Gran Canaria, Spain (RECRUITING)
- Hospital Dr. Negrín — Las Palmas de Gran Canaria, Las Palmas, Spain (RECRUITING)
- Hospital Clínico San Carlos — Madrid, Madrid, Spain (RECRUITING)
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Madrid, Spain (RECRUITING)
- Hospital 12 De Octubre — Madrid, Madrid, Spain (RECRUITING)
- Hospital Universitario la Paz — Madrid, Madrid, Spain (RECRUITING)
- Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain (RECRUITING)
- Hospital Universitario Regional de Málaga — Málaga, Málaga, Spain (RECRUITING)
- Complejo Hospitalario Universitario de Vigo — Vigo, Pontevedra, Spain (RECRUITING)
- Hospital Universitario La Fe — Valencia, Valencia, Spain (RECRUITING)
- Hospital Universitario Cruces — Barakaldo, Vizcaya, Spain (RECRUITING)
Study contacts
- Study coordinator: Eva Pereira
- Email: gecp@gecp.org
- Phone: +34934302006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stage IIIA Non-small Cell Lung Cancer, Neoadjuvant Treatment, Observational study, Resectable IIIA patients, Non small cell lung cancer, Pathological response