Open, Multicenter Observational Study of Docetaxel Utilized in Mono- or Combination Therapy for Treatment of Breast Cancer, NSCLC, Prostate Carcinoma, Adenocarcinoma of Stomach and Advanced Squamous Cell Carcinoma of Head/Neck Region.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Onkovis GmbH
- 入组人数
- 371
- 试验地点
- 3
- 主要终点
- the quantity of Doce onkovis needed pro treatment cycle
研究概览
简要总结
The main purpose of this observational study with Docetaxel is to determine the number of treatment cycles and the quantity of Doce onkovis needed therefore under the special circumstance of ambulant chemotherapy.
onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective.
Secondary objectives are the evaluation of the safety and tolerability of Doce onkovis. To this purpose data regarding co medications and adverse events are also collected.
研究设计
- 研究类型
- Observational
- 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 Docetaxel according to the SmPC and treating physician
排除标准
- •according to the Docetaxel SmPC
结局指标
主要结局
the quantity of Doce onkovis needed pro treatment cycle
时间窗: the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles).
Determine the quantity of Doce onkovis needed pro treatment cycle
次要结局
- adverse events during and after treatment(up to 24 weeks (8 cycles))