MedTrace Logo

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

NCT06646471 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-04-29

No results posted yet for this 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

Conditions

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.

Sponsors & Collaborators

  • GFPC Investigation

    lead OTHER

Principal Investigators

  • Laurent GREILLIER, Professor · Groupe Français de Pneumo-Cancérologie (GFPC)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-26
Primary Completion
2026-08-31
Completion
2028-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646471 on ClinicalTrials.gov