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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Bio-bank repository
GeneticBlood 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
Quality of Life (QoL)
Other interventionCollection 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
Procedure/SurgeryG-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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Real world cohort of NSCLC older adults patientsOther 3 interventions
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS)
The Progression Free Survival is defined as the time between treatment start date and event date defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 assessed locally. Frequency of this assessment is let to the investigator \'s discretion and local practices. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.
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 yearsSecondary outcomes
1
Objective Response Rate (ORR)
The objective response rate (ORR) is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by thorax-abdominal-pelvic and brain CT scans. The frequency of the tumor assessments will follow the site practices.
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 years2
Overall Survival (OS)
Overall survival (OS) is calculated as the time between the date of treatment initiation and date of death, and censored at date of last news for patients alive at the end of the study.
Time frame
From the treatment start date up to the date of death for a 2-year-period maximum3
Duration of Response (DOR)
The duration of response is defined as the time between the date of the first response assessed by RECIST 1.1 to the date of progression or death for any cause, whichever comes first, and censored at the date of last tumor evaluation for patients still responding to treatment at the end of the study (after 2 years).
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 maximum4
Time to Response (TTR)
Time to response is measured from the date of treatment initiation to the date of first response as defined by RECIST 1.1.
Time frame
From the start date of treatment up to the date of first response or for a 2-year-period maximumOther outcomes
1
Biobank sampling
Blood samples will be collected at inclusion, before the first administration of NSCLC therapy, for exploratory analyses in ancillary studies
Time frame
At inclusionSponsors and contacts
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Source ClinicalTrials.gov