跳至主要内容
临床试验/DRKS00007955
DRKS00007955已完成不适用

DOMINIC - Non-interventional Study about Dose modifications of Docetaxel in the therapy of metastatic castration resistant Prostate Cancer - DOMINIC

AxioNovo Gmbh0 个研究点目标入组 168 人开始时间: 2015年3月30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
AxioNovo Gmbh
入组人数
168

研究概览

简要总结

Since the study was discontinued after inclusion of approximately 25% of the planned number of patients, data were only available for the evaluation of 162 instead of the planned 600 patients. Almost 2/3 of the patients completed the NIS regularly, in almost 1/4 of the patients the therapy was discontinued prematurely and in 7.4% of the patients the therapy was continued beyond the NIS period. The overall tolerability of chemotherapy with docetaxel (docetaxel axios) was rated as 'very good' in 16.7% of patients and 'good' in 50.0% of patients. The general condition of the patients deteriorated during participation in the NIS. The proportion of patients with an ECOG of 0 or 1 decreased from 85.9% to 61.7%, while the mean Karnofsky index deteriorated from 86.7 to 78.9. The FACT-P questionnaire showed a slight deterioration in patients' well-being in four of the five subscales (not in 'Emotional Well-Being') and in all three total scores.

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 one(—)
性别
Male

入选标准

  • histologically confirmed prostate cancer
  • -Prostate cancer is castration resistance
  • -By Hand signed and dated consent

排除标准

  • - Contraindications to the use of oxaliplatin LIV Pharma according to the SmPC.
  • - The patient is participating in a study at the same time.

研究者

发起方
AxioNovo Gmbh

相似试验