PLANET: Pathological Response After Neoadjuvant Treatment on NSCLC

Sponsor

Fundación GECP (Other)

Overall Status

Recruiting

CT.gov ID

NCT05167487

Collaborator

(none)

150

Enrollment

Locations

9.1

Anticipated Duration (Months)

8.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IIIA Non-small Cell Lung Cancer	Drug: Cisplatin Drug: Carboplatin

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 13, 2021

Anticipated Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Sep 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery. Other Names: Cis-diammine-dichloroplatinum Platinol Drug: Carboplatin Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery. Other Names: Paraplatin

Arm

Intervention/Treatment

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

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

Other Names:

Cis-diammine-dichloroplatinum

Platinol

Drug: Carboplatin

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

Other Names:

Paraplatin

Outcome Measures

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. [From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months]
Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response.

Secondary Outcome Measures

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]
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
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]
Types of histopathological changes within tumor bed: fibrosis, lymphoid aggregates and others
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]
Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response.
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICO Badalona, Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
2	ICO Hospitalet	Hospitalet de Llobregat	Barcelona	Spain	08908
3	Hospital Universitario Insular de Gran canaria	Las Palmas De Gran Canaria	Gran Canaria	Spain	35016
4	Hospital Dr. Negrín	Las Palmas de Gran Canaria	Las Palmas	Spain	35010
5	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid	Spain	28222
6	Complejo Hospitalario Universitario de Vigo	Vigo	Pontevedra	Spain	36036
7	Hospital Universitario Cruces	Barakaldo	Vizcaya	Spain	48903
8	Hospital Universitario De A Coruna	A Coruña		Spain	15006
9	Hospital General Universitario de Alicante	Alicante		Spain	03010
10	Hospital Vall d'Hebron	Barcelona		Spain	08035
11	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
12	Hospital Clínico San Carlos	Madrid		Spain	28040
13	Hospital Universitario Fundación Jiménez Díaz	Madrid		Spain	28040
14	Hospital 12 De Octubre	Madrid		Spain	28041
15	Hospital Universitario la Paz	Madrid		Spain	28046
16	Hospital Universitario Regional de Málaga	Málaga		Spain	29010
17	Hospital Universitario La Fe	Valencia		Spain	46026