PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies
PROMETHEE
1 other identifier
interventional
500
1 country
41
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2024
Longer than P75 for phase_4
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2024
CompletedFirst Submitted
Initial submission to the registry
September 27, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
April 29, 2026
April 1, 2026
1.9 years
September 27, 2024
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
The Progression Free Survival is defined as the time between treatment start date and event date defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 assessed locally. Frequency of this assessment is let to the investigator \'s discretion and local practices. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.
From the date of first dose of treatment received until the date of the first documented disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause, whichever comes first, assessed up to 2 years
Secondary Outcomes (16)
Objective Response Rate (ORR)
From the date of first dose of treatment received until the date of the first documented disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause, whichever comes first, assessed up to 2 years
Overall Survival (OS)
From the treatment start date up to the date of death for a 2-year-period maximum
Duration of Response (DOR)
From the date of the first response to the date of progression or death, whichever comes first, or for a 2-year-period maximum
Time to Response (TTR)
From the start date of treatment up to the date of first response or for a 2-year-period maximum
Treatment Duration
From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum.
- +11 more secondary outcomes
Other Outcomes (1)
Biobank sampling
At inclusion
Study Arms (1)
Real world cohort of NSCLC older adults patients
OTHERCohort of patients ≥70 years of age with NSCLC treated in first line therapy for thoracic tumors according to ESMO-referenced therapeutic standards or according to an innovative molecule and/or strategy. An optional biobank based on blood samples taken during the screening phase prior to the first administration of systemic treatment will be collected. Sampling of tumoral materials will be collected prior to study participation and send for central reading. Patients will be asked to come at the hospital for their regular visits as per site current practice and to complete three quality of life questionnaires (EORTC QLQ-F17; QLQ-LC13; QLQ-ELD14).
Interventions
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
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: 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
CH du Pays d Aix
Aix-en-Provence, 13616, France
Hôpital Henri Duffaut
Avignon, 84000, France
Institut du Cancer d'Avignon
Avignon, 84918, France
CH Bastia
Bastia, 20600, France
Oncologie Thoracique Hôpital Morvan
Brest, 29200, France
Pneumologie Centre François Baclesse
Caen, 14000, France
CH Métropole-Savoie
Chambéry, 73000, France
Centre Hospitalier du Cotentin
Cherbourg, 50102, France
CHU Hôpital Montpied
Clermont-Ferrand, 63000, France
Pneumologie Hospices Civils de Colmar
Colmar, 68024, France
Pneumologie CHI Creteil
Créteil, 94010, France
CH Elbeuf
Elbeuf, 76503, France
Polyclinique de Blois
La Chaussée-Saint-Victor, 41260, France
CHD Les Oudairies
La Roche-sur-Yon, 85000, France
CH La Rochelle
La Rochelle, 17000, France
Hôpital A. Mignot
Le Chesnay, 78157, France
Hôpital Robert Boulin
Libourne, 33505, France
CHU Dupuytren
Limoges, 87042, France
Hôpital de la Vallée - Service Pneumologie
Longjumeau, 91160, France
Centre Léon Bérard
Lyon, 69373, France
Hôpital Européen de Marseille
Marseille, 13003, France
Oncologie Thoracique Hôpital Nord
Marseille, 13915, France
GHEF Site de Meaux
Meaux, 77100, France
Centre d Oncologie de Gentilly
Nancy, 54000, France
Pneumologie CHR
Orléans, 45067, France
Pneumologie Hôpital Cochin
Paris, 75014, France
Pneumologie Hôpital Tenon
Paris, 75970, France
Cantre Catalan d Oncologie
Perpignan, 66000, France
CH Annecy Genevois
Pringy, 74374, France
Pneumologie CHI Quimper
Quimper, 29000, France
CHU Hôpital Ponchailloux
Rennes, 35033, France
Pneumologie Hôpital Charles Nicolle
Rouen, 76031, France
Pneumologie CHU Felix Guyon
Saint-Denis, 97400, France
Pneumologie CHU St Etienne
Saint-Etienne, 42270, France
Clinique Mutualiste
Saint-Nazaire, 44600, France
CHU de la Réunion
Saint-Pierre, 97410, France
CLCC Paul Strauss
Strasbourg, 67000, France
Hôpital d'Instruction des Armées Saint-Anne
Toulon, 83041, France
CHITS Toulon Sainte Musse
Toulon, 83056, France
Oncologie CHBA
Vannes, 56000, France
Hôpital Nord OUest
Villefranche-sur-Saône, 69655, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Laurent GREILLIER, Professor
Groupe Français de Pneumo-Cancérologie (GFPC)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2024
First Posted
October 17, 2024
Study Start
September 26, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04