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PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies
Sponsor: GFPC Investigation
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
Official title: PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly
Key Details
Gender
All
Age Range
70 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-09-26
Completion Date
2028-08-31
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
Bio-bank repository
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
Quality of Life (QoL)
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.
G-Code
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.
Locations (41)
CH du Pays d Aix
Aix-en-Provence, France
Hôpital Henri Duffaut
Avignon, France
Institut du Cancer d'Avignon
Avignon, France
CH Bastia
Bastia, France
Oncologie Thoracique Hôpital Morvan
Brest, France
Pneumologie Centre François Baclesse
Caen, France
CH Métropole-Savoie
Chambéry, France
Centre Hospitalier du Cotentin
Cherbourg, France
CHU Hôpital Montpied
Clermont-Ferrand, France
Pneumologie Hospices Civils de Colmar
Colmar, France
Pneumologie CHI Creteil
Créteil, France
CH Elbeuf
Elbeuf, France
Polyclinique de Blois
La Chaussée-Saint-Victor, France
CHD Les Oudairies
La Roche-sur-Yon, France
CH La Rochelle
La Rochelle, France
Hôpital A. Mignot
Le Chesnay, France
Hôpital Robert Boulin
Libourne, France
CHU Dupuytren
Limoges, France
Hôpital de la Vallée - Service Pneumologie
Longjumeau, France
Centre Léon Bérard
Lyon, France
Hôpital Européen de Marseille
Marseille, France
Oncologie Thoracique Hôpital Nord
Marseille, France
GHEF Site de Meaux
Meaux, France
Centre d Oncologie de Gentilly
Nancy, France
Pneumologie CHR
Orléans, France
Pneumologie Hôpital Cochin
Paris, France
Pneumologie Hôpital Tenon
Paris, France
Cantre Catalan d Oncologie
Perpignan, France
CH Annecy Genevois
Pringy, France
Pneumologie CHI Quimper
Quimper, France
CHU Hôpital Ponchailloux
Rennes, France
Pneumologie Hôpital Charles Nicolle
Rouen, France
Pneumologie CHU Felix Guyon
Saint-Denis, France
Pneumologie CHU St Etienne
Saint-Etienne, France
Clinique Mutualiste
Saint-Nazaire, France
CHU de la Réunion
Saint-Pierre, France
CLCC Paul Strauss
Strasbourg, France
Hôpital d'Instruction des Armées Saint-Anne
Toulon, France
CHITS Toulon Sainte Musse
Toulon, France
Oncologie CHBA
Vannes, France
Hôpital Nord OUest
Villefranche-sur-Saône, France