Non-interventional Study on Quality of Life, Efficacy and Tolerability of Nab-paclitaxel/Gemcitabine Firstline Therapy in Patients With Metastatic Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Global Health Status/Quality of Life Score at 3 months
研究概览
简要总结
Current studies resulted in a superiority of a combination of nab-paclitaxel and gemcitabine vs. gemcitabine mono therapy, but no data are available yet on the quality of life (QoL) under this combination therapy. In the framework of a German multicenter prospective, observational study ('QoliXane'), detailed QoL-data are now collected. QoL development under treatment will be analyzed and data will be compared to existing data of the gemcitabine mono therapy.
QoL and course of therapy are collected using the EORTC C30 questionnaires once a month over a 6-month period. Additionally patients are requested to answer a supplementary questionnaire addressing e.g. fears related to QoL deterioration and side effects of chemotherapy. Primary endpoint is the proportion of patients with maintained Global Health Status/QoL at 3 months (10 points threshold). 600 patients shall be enrolled at about 90 study sites in Germany.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •metastatic pancreatic carcinoma
- •no previous therapy in the metastatic stage
- •planned firstline therapy with nab-paclitaxel and gemcitabine
排除标准
- •previous therapy in the metastatic stage
- •patient unable to understand the study and to give informed consent
- •patient unable to answer quality of life questionnaires
结局指标
主要结局
Global Health Status/Quality of Life Score at 3 months
时间窗: 3 months
Rate of patients without deterioration of their global health status/quality of life score according to EORTC QLQ-C30 after 3 months
次要结局
- Adverse events(6 months)
- Progression free survival as assessed by tumor response(6 months)
- Efficacy in high ECOG and high bilirubin patients(6 months)
- Global Health Status/Quality of Life Score at 6 months(6 months)
- Limited Baseline Condition(3 and 6 months)
- Therapy effects on Global Health Status/Quality of Life Score(3 months)
- Median time until definitive deterioration of Global Health Status/Quality of Life Score and other functional and symptom scales of EORTC QLQ-C30(6 months)
- Adverse events in special subgroups like high ECOG or high bilirubin patients(6 months)
- Prognostic validity of Global Health Status/Quality of Life Score as assessed by tumor response and EORTC QLQ-C30(6 months)
- Influence of Neuropathy on Quality of Life compared to other treatment-related adverse events as assessed by CTCAE v4.0(6 months)
- Comparison of Global Health/Quality of Life scores as assessed by EORTC QLQ-C30 to historical Global Health/Quality of Life score data of gemcitabine mono-therapy(6 months)
- Tumor response (RECIST)(6 months)
- Overall survival as assessed by survival data one year after patient enrollment(1 year)
- Correlations of tumor response and survival with genetic alterations(6 months)