PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 82
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 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
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.
次要结局
- Objective Response Rate (ORR)(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)(From the treatment start date up to the date of death for a 2-year-period maximum)
- Duration of Response (DOR)(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)(From the start date of treatment up to the date of first response or for a 2-year-period maximum)
- Treatment Duration(From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum.)
- Safety events(From the enrollment up to the participants study end date or for a 2-year-period maximum)
- Treatments description(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(From the enrollment up to the participant study end date or for a 2-year-period maximum)
- Geriatric interventions: specialized exercises(From the enrollment up to the participant study end date or for a 2-year-period maximum)
- Geriatric interventions: specialized help at home(From the enrollment up to the participant study end date or for a 2-year-period maximum)
- Geriatric interventions: specialized medications(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)(At enrolment, at 12 weeks, at 6 months and at 12 months.)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-ELDerly 14 (QLQ-ELD14)(At enrolment, at 12 weeks, at 6 months and at 12 months)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)(At enrolment, at 12 weeks, at 6 months and at 12 months)
- Geriatric characteristics G8 score(At enrollment and at disease progression for a maximum of 2-year-period.)
- Geriatric characteristics Geriatric Core DatasEt (G-CODE)(At enrollment and at disease progression for a maximum of 2-year-period.)