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

Official title

PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly

Overview

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

Interventions

• Genetic 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
• Other 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.
• Procedure 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.

Primary outcome measures

• Progression Free Survival (PFS) [Time frame: 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 outcome measures (12)

• Objective Response Rate (ORR) [Time frame: 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) [Time frame: From the treatment start date up to the date of death for a 2-year-period maximum]
• Duration of Response (DOR) [Time frame: 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) [Time frame: From the start date of treatment up to the date of first response or for a 2-year-period maximum]
• Treatment Duration [Time frame: From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum.]
• Safety events [Time frame: From the enrollment up to the participants study end date or for a 2-year-period maximum]
• Treatments description [Time frame: From the start date of the NSCLC treatment up to the participant study end date or for a 2-year-period maximum]
• Geriatric interventions: specialized consultations [Time frame: From the enrollment up to the participant study end date or for a 2-year-period maximum]
• Geriatric interventions: specialized exercises [Time frame: From the enrollment up to the participant study end date or for a 2-year-period maximum]
• Geriatric interventions: specialized help at home [Time frame: From the enrollment up to the participant study end date or for a 2-year-period maximum]
• Geriatric interventions: specialized medications [Time frame: From the enrollment up to the participant study end date or for a 2-year-period maximum]
• European Organisation for Research and Treatment of Cancer Core Function Questionnaire (QLQ-F17) [Time frame: At enrolment, at 12 weeks, at 6 months and at 12 months.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

France · 41 centers

• CH du Pays d Aix — Aix-en-Provence
• Hôpital Henri Duffaut — Avignon
• Institut du Cancer d'Avignon — Avignon
• CH Bastia — Bastia
• Oncologie Thoracique Hôpital Morvan — Brest
• Pneumologie Centre François Baclesse — Caen
• CH Métropole-Savoie — Chambéry
• Centre Hospitalier du Cotentin — Cherbourg
• … and 33 more centers

Identifiers

NCT: NCT06646471 · GFPC 05-2023

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗