Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 318
- 试验地点
- 62
- 主要终点
- overall survival
研究概览
简要总结
Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib
详细描述
Several French studies on crizotinib have been conducted in recent years. These are not only patients treated in the PROFILE 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient ATU followed by the cohort ATU (Expended Access Cohort). Under the ATU program and according to ATU regulations, a limited set of data is collected and furthermore the follow up is stopped as soon as the ATU program closes. Thus it is not possible to have access to long term data and post progression data. Our project is to collect data from the patients from the ATU program (named patient and cohort) and if possible patients treated after the marketing of crizotinib, before, during and after crizotinib therapy. Centers selected for this observational study will be those of the IFCT network that took part in the ATU program.
This will allow an accurate analysis of crizotinib therapy under "real life" conditions. It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have locally advanced or metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK determined by IHC and/or FISH.
- •Patient who received crizotinib on an expanded access basis (compassionate use) (ATU) due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable
- •Patient who received marketed crizotinib as a result of the standard care of metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK will also be eligible.
- •Patient was able to swallow capsules and had no surgical or anatomical condition that precluded the patient from swallowing and absorbing oral medications on an ongoing basis.
- •Patient has taken at least 1 week of treatment
排除标准
- •Patient included in a crizotinib clinical trial
- •Patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
结局指标
主要结局
overall survival
时间窗: 5 years
overall survival post-progression on crizotinib
次要结局
- rare and severe complications of crizotinib therapy(5 years)