Pathological Response After Neoadjuvant Treatment on NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cisplatin, Carboplatin.
- Who it may be relevant to
- Registry conditions: Stage IIIA Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes
Overview
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.
Interventions
- Drug Cisplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery. - Drug Carboplatin
Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.
Primary outcome measures
- 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. [Time frame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months]
Secondary outcome measures (4)
- To describe the percentage of residual viable tumor in this population of patients under common criteria [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 [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 [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 [Time frame: From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Spain · 17 centers
- Hospital Universitario De A Coruna — A Coruña
- Hospital General Universitario de Alicante — Alicante
- ICO Badalona, Hospital Germans Trias i Pujol — Badalona
- Hospital Vall d'Hebron — Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona
- ICO Hospitalet — L'Hospitalet de Llobregat
- Hospital Universitario Insular de Gran canaria — Las Palmas de Gran Canaria
- Hospital Dr. Negrín — Las Palmas de Gran Canaria
- … and 9 more centers
Identifiers
NCT: NCT05167487 · GECP 21/03_PLANET