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

Официальное название

PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly

Обзор

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

Вмешательства

• Генная терапия 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
• Другое 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.
• Процедура 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.

Первичные конечные точки

• Progression Free Survival (PFS) [Срок оценки: 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 years]

Вторичные конечные точки (12)

• Objective Response Rate (ORR) [Срок оценки: 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 years]
• Overall Survival (OS) [Срок оценки: From the treatment start date up to the date of death for a 2-year-period maximum]
• Duration of Response (DOR) [Срок оценки: From the date of the first response to the date of progression or death, whichever comes first, or for a 2-year-period maximum]
• Time to Response (TTR) [Срок оценки: From the start date of treatment up to the date of first response or for a 2-year-period maximum]
• Treatment Duration [Срок оценки: From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum.]
• Safety events [Срок оценки: From the enrollment up to the participants study end date or for a 2-year-period maximum]
• Treatments description [Срок оценки: From the start date of the NSCLC treatment up to the participant study end date or for a 2-year-period maximum]
• Geriatric interventions: specialized consultations [Срок оценки: From the enrollment up to the participant study end date or for a 2-year-period maximum]
• Geriatric interventions: specialized exercises [Срок оценки: From the enrollment up to the participant study end date or for a 2-year-period maximum]
• Geriatric interventions: specialized help at home [Срок оценки: From the enrollment up to the participant study end date or for a 2-year-period maximum]
• Geriatric interventions: specialized medications [Срок оценки: From the enrollment up to the participant study end date or for a 2-year-period maximum]
• European Organisation for Research and Treatment of Cancer Core Function Questionnaire (QLQ-F17) [Срок оценки: At enrolment, at 12 weeks, at 6 months and at 12 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 41 центр

• CH du Pays d Aix — Aix-en-Provence
• Hôpital Henri Duffaut — Avignon
• Institut du Cancer d'Avignon — Avignon
• CH Bastia — Bastia
• Oncologie Thoracique Hôpital Morvan — Brest
• Pneumologie Centre François Baclesse — Caen
• CH Métropole-Savoie — Chambéry
• Centre Hospitalier du Cotentin — Cherbourg
• … и ещё 33 центра

Идентификаторы

NCT: NCT06646471 · GFPC 05-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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