Open, Multicenter Observational Study of Irinotecan Utilized in Mono- or Combination Therapy for the Treatment of Advanced Colorectal Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Onkovis GmbH
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- The Quantity of Irinotecan onkovis needed per treatment cycle
研究概览
简要总结
The main purpose of this observational study with Irinotecan onkovis is to determine the number of treatment cycles and the quantity of Irinotecan onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.
Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.
Secondary objective is the assessment of the side effects of Irinotecan onkovis. To this end, data regarding co-medication and adverse events are also collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for Irinotecan according to the SmPC and treating physician
排除标准
- •according to the Irinotecan SmPC
结局指标
主要结局
The Quantity of Irinotecan onkovis needed per treatment cycle
时间窗: up to 24 weeks
Determine the quantity of Irinotecan onkovis needed pro treatment cycle
次要结局
- Adverse events during and after treatment(up to 24 weeks)