NCT03730558已完成不适用
Non-comparative Prospective Observational Cohort Study Describing the Safety and Efficacy of Aflibercept Administered in Combination with FOLFIRI After Failure Under Oxaliplatin + Anti-EGFR Therapy in the Treatment of Patients with Metastatic Colorectal Cancer in Practice Common
Recherche clinique2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年11月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of aflibercept in terms of progression-free survival (PFS) in association with FOLFIRI in patients treated in common practice for metastatic colorectal cancer (CCRM) after failure of oxaliplatin + anti-EGFR-based treatment
研究概览
简要总结
Primary objective
- Evaluate the efficacy in terms of progression-free survival (PFS) of aflibercept in combination with FOLFIRI in patients treated routinely for metastatic colorectal cancer (mCRC) after failure of treatment with oxaliplatin + EGFR.
Secondary objective
-
Evaluate the efficacy of aflibercept in combination with FOLFIRI on the 2-year overall survival rate and the objective response rate.
-
Evaluate the tolerance profile of aflibercept in combination with FOLFIRI.
-
Observational study, national, multicenter, cohort, prospective without intervention on the therapeutic strategy.•
详细描述
Inclusion criteria
- All patients expected to be treated with aflibercept in combination with FOLFIRI for a mCRC, after failure of treatment with oxaliplatin + anti-EGFR on the decision of the doctor (situation included in the framework of the MA of aflibercept) .
- Age ≥18 years
- Signature of the agreement for the collection of medical and personal data. (Patients who have received FOLFIRINOX in the first line metastatic are allowed) Note: Failure is defined as progression during or within 6 months after discontinuation of oxaliplatin
Exclusion criteria :
- Concurrent participation in a clinical trial
- Patients who have previously received anti-VEGF agents and / or aflibercept in one trial.
- Patients who received FOLFIRI in the first metastatic line.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Evaluate the efficacy of aflibercept in terms of progression-free survival (PFS) in association with FOLFIRI in patients treated in common practice for metastatic colorectal cancer (CCRM) after failure of oxaliplatin + anti-EGFR-based treatment
时间窗: 2 years
progression-free survival (PFS)
次要结局
未报告次要终点
研究者
Recherche clinique
Dr Laurent Mineur
Institut Sainte Catherine
研究点 (2)
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