A Non-interventional Study to Assess Effectiveness and Safety of Trifluridin/tipiracil in Patients with Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Servier
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
A non-interventional, prospective, open, multicenter study in Germany in patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies and with decision for treatment with trifluridin/tipiracil.
详细描述
The purpose of this NIS, after market approval of trifluridin/tipiracil as treatment for mCRC patients who have been previously treated with, or are not considered candidates for, available therapies, is to evaluate effectiveness, QoL, treatment details and safety of trifluridin/tipiracil treatment in a real-world setting. In addition, therapy management and health economic parameters regarding trifluridin/tipiracil treatment will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Aged 18 years or older.
- •Patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
- •Indication for treatment as assessed by the treating physician.
- •Decision for treatment with trifluridin/tipiracil.
- •Signed written informed consent.
- •Criteria according to current Summary of Product Characteristics (SmPC) for patients treated with trifluridin/tipiracil.
- •Ability to read and understand German.
排除标准
- •Contraindications according to SmPC for metastatic colorectal cancer patients treated with trifluridin/tipiracil.
- •Participation in a clinical trial within 30 days prior to enrollment or simultaneous participation in a clinical trial.
结局指标
主要结局
Overall survival
时间窗: Baseline up to 3 years
time from first administration of trifluridin/tipiracil to death from any cause
次要结局
- Trifluridin/tipiracil treatment details(Baseline up to 3 years)
- Safety laboratory values of participants(Baseline up to 3 years)
- Progression-free survival(Baseline up to 3 years)
- Overall response rate(Baseline up to 3 years)
- Disease control rate 8 weeks(Baseline up to 3 years)
- AEs and SAEs according to NCI CTCAE(Baseline up to 3 years)
- Therapy management (use of relevant supportive medications)(Baseline up to 3 years)
- Patient-reported outcomes (PROs) on quality of life (QoL)(Baseline up to 3 years)