Trial Title:
PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies
NCT ID:
NCT06646471
Condition:
Non Small Cell Lung Cancer
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Bio-bank repository
Description:
Blood samples taken during the screening phase prior to the first administration of
systemic treatment and stored in a repository for a maximum duration of 10 years
Arm group label:
Real world cohort of NSCLC older adults patients
Intervention type:
Other
Intervention name:
Quality of Life (QoL)
Description:
Collection of EORTC QoL questionnaires QLQ-F17, QLQ-LC13 and QLQ-ELD14:
- stage 3 non-operable/non-radiable, stage 4: at inclusion, 12 weeks, 6 months of
treatment, first-line progression.
- operable stage 1 to 3b: at inclusion, end of neoadjuvant period before surgery
post-operative baseline, at 6 months, at 12 months.
- radiable stages 3a to 3c: at inclusion, at the end of thoracic radiotherapy, at 6
months, at 12 months.
Arm group label:
Real world cohort of NSCLC older adults patients
Intervention type:
Procedure
Intervention name:
G-Code
Description:
G-CODE: Katz Autonomy Scale (ADL), Instrumental Activities of Daily Living questionnaire
(IADL), Charlson score, mini GDS, mini COG, falls history, Timed Get Up and Go test,
social environment.
Arm group label:
Real world cohort of NSCLC older adults patients
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient ≥70 years
- Non-small-cell lung cancer for which the multidisciplinary consultation required
systemic 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 in
routine 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 Criteria:
- Patients under guardians or curators
- Patient not under the care of the investigating center and not monitored by the
investigating center
- Patient already treated with systemic therapy for NSCLC
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CH du Pays d Aix
Address:
City:
Aix En Provence
Zip:
13616
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Stéphanie MARTINEZ
Email:
smartinez@ch-aix.fr
Facility:
Name:
Hôpital Henri Duffaut
Address:
City:
Avignon
Zip:
84000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Nicolas CLOAREC
Email:
clarec.nicolas@ch-avignon.fr
Facility:
Name:
CH Bastia
Address:
City:
Bastia
Zip:
20600
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pascal THOMAS
Email:
pascal.thomas@ch-bastia.fr
Facility:
Name:
Oncologie Thoracique Hôpital Morvan
Address:
City:
Brest
Zip:
29200
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Renaud DESCOURT
Email:
renaud.descourt@chu-brest.fr
Facility:
Name:
Pneumologie Centre François Baclesse
Address:
City:
Caen
Zip:
14000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Hubert CURCIO
Email:
h.curcio@baclesse.unicncer.fr
Facility:
Name:
CH Métropole-Savoie
Address:
City:
Chambery
Zip:
73000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Julian PINSOLLE
Email:
julian.pinsolle@ch-metropole-savoie.fr
Facility:
Name:
CHU Hôpital Montpied
Address:
City:
Clermont-ferrand
Zip:
63000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Patrick MERLE
Email:
pmerle@chu-clermontferrand.fr
Facility:
Name:
Pneumologie Hospices Civils de Colmar
Address:
City:
Colmar
Zip:
68024
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lionel MOREAU
Email:
lionel.moreau@ch-colmar.fr
Facility:
Name:
Pneumologie CHI Creteil
Address:
City:
Creteil
Zip:
94010
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Isabelle MONNET
Email:
isabelle.monnet@chicreteil.fr
Facility:
Name:
CH Elbeuf
Address:
City:
Elbeuf
Zip:
76503
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre Alexandre HAUSS
Email:
Pierre-Alexandre.Hauss@chi-elbeuf-louviers.fr
Facility:
Name:
Polyclinique de Blois
Address:
City:
La Chaussee Saint Victor
Zip:
41260
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Philippe LAPLAIGE
Email:
dr.laplaige@wanadoo.fr
Facility:
Name:
CHD Les Oudairies
Address:
City:
La Roche Sur Yon
Zip:
85000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Acya BIZIEUX
Email:
acya.bizieux@ght85.fr
Facility:
Name:
CH La Rochelle
Address:
City:
La Rochelle
Zip:
17000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marion LAFARGE
Email:
marion.lafarge@ght-atlantique17.fr
Facility:
Name:
Hôpital A. Mignot
Address:
City:
Le Chesnay
Zip:
78157
Country:
France
Status:
Recruiting
Contact:
Last name:
Cécile DUJON
Email:
Cdujon@ght78sud.fr
Facility:
Name:
Hôpital Robert Boulin
Address:
City:
Libourne
Zip:
33505
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Samir ABDICHE
Email:
menouar-samir.abdiche@ch-libourne.fr
Facility:
Name:
CHU Dupuytren
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Yannick SIMONNEAU
Email:
yannick.simonneau@chu-limoges.fr
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Chantal DECROISETTE
Email:
chantal.decroisette@lyon.unicancer.fr
Facility:
Name:
Oncologie Thoracique Hôpital Nord
Address:
City:
Marseille
Zip:
13915
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laurent GREILLIER
Email:
laurent.greillier@ap-hm.fr
Facility:
Name:
GHEF Site de Meaux
Address:
City:
Meaux
Zip:
77100
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Chrystèle LOCHER
Email:
chlocher@ghef.fr
Facility:
Name:
Centre d Oncologie de Gentilly
Address:
City:
Nancy
Zip:
54000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laurene GAVOILLE
Email:
L.gavoille@oncog.fr
Facility:
Name:
Pneumologie CHR
Address:
City:
Orleans
Zip:
45067
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Hugues MOREL
Email:
hugues.morel@chr-orleans.fr
Facility:
Name:
Pneumologie Hôpital Cochin
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marie WISLEZ
Email:
marie.wislez@aphp.fr
Facility:
Name:
Pneumologie Hôpital Tenon
Address:
City:
Paris
Zip:
75970
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Constance METEYE
Email:
constance.meteye@aphp.fr
Facility:
Name:
Cantre Catalan d Oncologie
Address:
City:
Perpignan
Zip:
66000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sabine VIEILLOT
Email:
sabinevieillot@gmail.com
Facility:
Name:
CH Annecy Genevois
Address:
City:
Pringy
Zip:
74374
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Emilie PLUQUET
Email:
epluquet@ch-annecygenevois.fr
Facility:
Name:
Pneumologie CHI Quimper
Address:
City:
Quimper
Zip:
29000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Romain CORRE
Email:
romain.corre@ch-cornouaille.fr
Facility:
Name:
CHU Hôpital Ponchailloux
Address:
City:
Rennes
Zip:
35033
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Charles RICORDEL
Email:
charles.ricordel@chu-rennes.fr
Facility:
Name:
Pneumologie Hôpital Charles Nicolle
Address:
City:
Rouen
Zip:
76031
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Florian GUISIER
Email:
florian.guisier@chu-rouen.fr
Facility:
Name:
Pneumologie CHU Felix Guyon
Address:
City:
Saint Denis
Zip:
97400
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Diane MOREAU
Email:
diane.moreau@chu-reunion.fr
Facility:
Name:
Clinique Mutualiste
Address:
City:
Saint Nazaire
Zip:
44600
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Thierry CHATELLIER
Email:
thierry.chatellier@hospigrandouest.fr
Facility:
Name:
Pneumologie CHU St Etienne
Address:
City:
Saint-etienne
Zip:
42270
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sophie BAYLE-BLEUEZ
Email:
sophie.bayle@chu-st-etienne.fr
Facility:
Name:
CHU de la Réunion
Address:
City:
Saint-pierre
Zip:
97410
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Eric HUCHOT
Email:
eric.huchot@chu-reunion.fr
Facility:
Name:
CLCC Paul Strauss
Address:
City:
Strasbourg
Zip:
67000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Roland SCHOTT
Email:
r.schott@icans.eu
Facility:
Name:
Hôpital d'Instruction des Armées Saint-Anne
Address:
City:
Toulon
Zip:
83041
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Olivier BYLICKI
Email:
bylicki.olivier@yahoo.fr
Facility:
Name:
CHITS Toulon Sainte Musse
Address:
City:
Toulon
Zip:
83056
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Clarisse AUDIGIER VALETTE
Email:
clarisse.audigier-valette@ch-toulon.fr
Facility:
Name:
Oncologie CHBA
Address:
City:
Vannes
Zip:
56000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Gonzague DE CHABOT
Email:
gonzague.dechabot@ch-bretagne-atlantique.fr
Facility:
Name:
Hôpital Nord OUest
Address:
City:
Villefranche Sur Saone
Zip:
69655
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lionel FALCHERO
Email:
LFalchero@lhopitalnordouest.fr
Start date:
September 26, 2024
Completion date:
August 31, 2028
Lead sponsor:
Agency:
Groupe Francais De Pneumo-Cancerologie
Agency class:
Other
Source:
Groupe Francais De Pneumo-Cancerologie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06646471
