Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice
详细描述
Nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be effective after gemcitabine-based treatment in patients with metastatic pancreatic adenocarcinoma in the phase III NAPOLI-1 randomized trial.
Nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-FU) and leucovorin (LV), as it has shown an improvement in overall survival (median +1.9 months, HR = 0.67) compared to 5-FU/LV alone, without degradation of quality-of-life scales.
However, patients included in clinical trials regularly differ from patients in routine practice, and a real-life study is fundamental in this poor prognosis situation where quality of life preservation is paramount
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •18 years or older
- •histological or cytological confirmation of pancreatic ductal adenocarcinoma
- •measurable lesion(s)
- •progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant protocol (only if remote metastases developed within 6 months of the end of adjuvant treatment), locally advanced, or metastatic phase. They may have already received irinotecan and/or fluorouracil.
- •Performance Status (PS) 0 or 1
- •Oral consent
- •Health insurance
排除标准
- •symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease)
- •thromboembolic events within six months of inclusion;
- •Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled hypertension.
- •Patient under legal protection
- •Hypersensitivity to irinotecan
- •Breast feeding
结局指标
主要结局
Overall survival
时间窗: Up to 3 years
次要结局
- Progression-free survival(Every 3 months up to 3 years)
- Response rate to treatment(Every 3 months up to 3 years)
- Cost evaluation(Every 3 months up to 3 years)