Pathological Response After Neoadjuvant Treatment on NSCLC

Stage IIIA Non-small Cell Lung Cancer Clinical Trial

— PLANET  

Official title:

Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05167487
• Other study ID #: GECP 21/03_PLANET
• Status: Recruiting
• Start date: December 13, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2023
• Source: Fundación GECP
• Contact: Eva Pereira
• Phone: +34934302006
• Email: gecp[@]gecp.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 1, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Stage IIIA Non-small Cell Lung Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario De A Coruna	A Coruña
Spain	Hospital General Universitario de Alicante	Alicante
Spain	ICO Badalona, Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitario Cruces	Barakaldo	Vizcaya
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	ICO Hospitalet	Hospitalet de Llobregat	Barcelona
Spain	Hospital Dr. Negrín	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario Insular de Gran canaria	Las Palmas De Gran Canaria	Gran Canaria
Spain	Hospital 12 De Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario la Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Regional de Málaga	Málaga
Spain	Hospital Universitario La Fe	Valencia
Spain	Complejo Hospitalario Universitario de Vigo	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Fundación GECP

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To describe the percentage of residual viable tumor in this population of patients under common criteria	A) No response or more than 70% of viable tumor: Lymph node major pathological response negative (LN-MPR)- B) =70% of viable tumor cells: Lymph node major pathological response positive (LN-MPR)+ C) No evidence of any viable tumor (including primary tumor): Complete pathological response	From the end of neoadjuvant treatment until the last follow up or death,assessed up to 45 months
Secondary	To describe the histopathological changes within tumor bed associated to tumor response	Types of histopathological changes within tumor bed: fibrosis, lymphoid aggregates and others	From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
Secondary	To correlate pathological response and post-surgical complications	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	To describe the relation between nodal downstaging after neoadjuvant treatment and overall survival	Downstaging after surgery is a reduction in the stage of a cancer. Overall Survival defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.	From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months

External Links

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