PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies

Last updated: October 16, 2024
Sponsor: Groupe Francais De Pneumo-Cancerologie
Overall Status: Active - Recruiting

Phase

4

Condition

Non-small Cell Lung Cancer

Lung Cancer

Lung Disease

Treatment

G-Code

Quality of Life (QoL)

Bio-bank repository

Clinical Study ID

NCT06646471
GFPC 05-2023
  • Ages > 70
  • All Genders

Study Summary

The objective of the study is to prospectively generate real-life data in patients aged ≥70 years treated in first line for a thoracic tumor (Non-Small-Cell Lung Carcinoma) according to best standard of care as defined by the European Society for Medical Oncology (ESMO). This cohort will aim to:

  • characterize participants in terms of geriatrics, biology and carcinology

  • describe the treatment modalities by stage, as well as the results in terms of efficacy, safety and impact on quality of life.

At the same time, exploratory sub-cohorts will be identified including participants treated uniformly with the same molecule, and/or the same innovative strategy.

Participants will be followed in accordance with investigator's usual clinical practice at the corresponding site. They will be asked to:

  • visit the clinic as per physician's request for checkups and tests for assessing general condition and clinical efficacy and tolerance of current treatment.

  • perform the necessary regular para-clinical examinations (lab testing, imaging, re-biopsy).

  • provide blood samples for bio-bank repository

  • perform assessments specific to older adults

  • answer three quality of life questionnaires

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient ≥70 years

  • Non-small-cell lung cancer for which the multidisciplinary consultation requiredsystemic treatment regardless of Tumor-Node-Metastasis (TNM) stage

  • Patient naïve to systemic anticancer treatment for bronchial neoplasia

  • Patient covered by social security

  • Patient eligible for systemic treatment

  • Systemic treatment with marketing authorization in the indication, available inroutine care early access or compassionate access.

  • Patient able to understand the protocol

  • Patient not opposed to the collection of data concerning him/her

  • Signature of study consent form.

Exclusion

Exclusion Criteria:

  • Patients under guardians or curators

  • Patient not under the care of the investigating center and not monitored by theinvestigating center

  • Patient already treated with systemic therapy for NSCLC

Study Design

Total Participants: 500
Treatment Group(s): 3
Primary Treatment: G-Code
Phase: 4
Study Start date:
September 26, 2024
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • CH du Pays d Aix

    Aix En Provence, 13616
    France

    Site Not Available

  • Hôpital Henri Duffaut

    Avignon, 84000
    France

    Site Not Available

  • CH Bastia

    Bastia, 20600
    France

    Site Not Available

  • Oncologie Thoracique Hôpital Morvan

    Brest, 29200
    France

    Site Not Available

  • Pneumologie Centre François Baclesse

    Caen, 14000
    France

    Site Not Available

  • CH Métropole-Savoie

    Chambery, 73000
    France

    Site Not Available

  • CHU Hôpital Montpied

    Clermont-ferrand, 63000
    France

    Site Not Available

  • Pneumologie Hospices Civils de Colmar

    Colmar, 68024
    France

    Site Not Available

  • Pneumologie CHI Creteil

    Creteil, 94010
    France

    Site Not Available

  • CH Elbeuf

    Elbeuf, 76503
    France

    Site Not Available

  • Polyclinique de Blois

    La Chaussee Saint Victor, 41260
    France

    Site Not Available

  • CHD Les Oudairies

    La Roche Sur Yon, 85000
    France

    Site Not Available

  • CH La Rochelle

    La Rochelle, 17000
    France

    Site Not Available

  • Hôpital A. Mignot

    Le Chesnay, 78157
    France

    Active - Recruiting

  • Hôpital Robert Boulin

    Libourne, 33505
    France

    Site Not Available

  • CHU Dupuytren

    Limoges, 87042
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69373
    France

    Site Not Available

  • Oncologie Thoracique Hôpital Nord

    Marseille, 13915
    France

    Site Not Available

  • GHEF Site de Meaux

    Meaux, 77100
    France

    Site Not Available

  • Centre d Oncologie de Gentilly

    Nancy, 54000
    France

    Site Not Available

  • Pneumologie CHR

    Orleans, 45067
    France

    Site Not Available

  • Pneumologie Hôpital Cochin

    Paris, 75014
    France

    Site Not Available

  • Pneumologie Hôpital Tenon

    Paris, 75970
    France

    Site Not Available

  • Cantre Catalan d Oncologie

    Perpignan, 66000
    France

    Site Not Available

  • CH Annecy Genevois

    Pringy, 74374
    France

    Site Not Available

  • Pneumologie CHI Quimper

    Quimper, 29000
    France

    Site Not Available

  • CHU Hôpital Ponchailloux

    Rennes, 35033
    France

    Site Not Available

  • Pneumologie Hôpital Charles Nicolle

    Rouen, 76031
    France

    Site Not Available

  • Pneumologie CHU Felix Guyon

    Saint Denis, 97400
    France

    Site Not Available

  • Clinique Mutualiste

    Saint Nazaire, 44600
    France

    Site Not Available

  • Pneumologie CHU St Etienne

    Saint-etienne, 42270
    France

    Site Not Available

  • CHU de la Réunion

    Saint-pierre, 97410
    France

    Site Not Available

  • CLCC Paul Strauss

    Strasbourg, 67000
    France

    Site Not Available

  • CHITS Toulon Sainte Musse

    Toulon, 83056
    France

    Site Not Available

  • Hôpital d'Instruction des Armées Saint-Anne

    Toulon, 83041
    France

    Site Not Available

  • Oncologie CHBA

    Vannes, 56000
    France

    Site Not Available

  • Hôpital Nord OUest

    Villefranche Sur Saone, 69655
    France

    Site Not Available

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