PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age70+
SponsorGFPC Investigation
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bio-bank repository
- Quality of Life (QoL)
- G-Code
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov