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
Inclusion Criteria9
- 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 Criteria3
- 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
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)
View Full Details on ClinicalTrials.gov
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NCT06646471