Metastatic Pancreatic Cancer Clinical Trial
Official title:
Non-interventional Study on Quality of Life, Efficacy and Tolerability of Nab-paclitaxel/Gemcitabine Firstline Therapy in Patients With Metastatic Pancreatic Cancer
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.
n/a
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