PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies
PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly
GFPC Investigation
500 participants
Sep 26, 2024
INTERVENTIONAL
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
Eligibility
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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.
Locations(41)
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NCT06646471