Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination With 5FU/or in FOLFIRI Regimen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Prospective observational study comparing calcium and sodium levofolinate in combination with 5FU/or in FOLFIRI regimen on patients affected by gastrointestinal cancer (any site of disease along with gastrointestinal tract) who have been prescribed FOLFIRI in standard clinical practice.
详细描述
This is an observational, perspective trial on patients affected by gastrointestinal cancer (any site of disease along with gastrointestinal tract) who have been prescribed FOLFIRI in standard clinical practice. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients affected by gastrointestinal cancer including:
- •advanced colon-rectal cancer,
- •biliary tract cancer,
- •pancreatic carcinoma,
- •advanced gastric or gastro-esophageal junction adenocarcinoma requiring treatment according to folfiri schedule
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female aged >18 years.
- •Life expectancy > 3 months
- •Performance Status (PS) 0-1
- •Exclusion criteria:
- •Patients with known hypersensitivity to 5-FU or folinic acid , or to any of the excipients
排除标准
- 未提供
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: up to 2 years
Safety profiles of Na-Lev and Ca-Lev when administered in combination with 5-FU in FOLFIRI regimen to cancer patients under standard clinical practice. Reported Adverse Events (AE) will be summarized by system organ class, seriousness, severity (according to NCI -Common Terminology Criteria for Adverse Events, CTCAE version 4.0) and relationship to study drug. Comparison between groups will be performed using non parametric statistical test.
次要结局
- economical impact(up to 2 years)
- organizational impact on Drug production(up to 2 years)