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.
Study Type
OBSERVATIONAL
Enrollment
600
EORTC QLQ-C30 questionnaire
Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research
Frankfurt, Germany
Global Health Status/Quality of Life Score at 3 months
Rate of patients without deterioration of their global health status/quality of life score according to EORTC QLQ-C30 after 3 months
Time frame: 3 months
Global Health Status/Quality of Life Score at 6 months
Rate of patients with an improvement of their global health status/quality of life score according to EORTC QLQ-C30 after 6 months
Time frame: 6 months
Limited Baseline Condition
Rate of patients with a limited baseline general condition (ECOG 2 or 3) and stable or improved Global Health Status/Quality of Life Score after 3 and 6 months
Time frame: 3 and 6 months
Therapy effects on Global Health Status/Quality of Life Score
Effect of therapy on Global Health Status/Quality of Life Score and other symptoms and scales assessed by EORTC QLQ-C30: rate of patients with improved, stable or deteriorated score
Time frame: 3 months
Prognostic validity of Global Health Status/Quality of Life Score as assessed by tumor response and EORTC QLQ-C30
Time frame: 6 months
Median time until definitive deterioration of Global Health Status/Quality of Life Score and other functional and symptom scales of EORTC QLQ-C30
Time frame: 6 months
Influence of Neuropathy on Quality of Life compared to other treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 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
Time frame: 6 months
Tumor response (RECIST)
Time frame: 6 months
Progression free survival as assessed by tumor response
Time frame: 6 months
Overall survival as assessed by survival data one year after patient enrollment
Time frame: 1 year
Efficacy in high ECOG and high bilirubin patients
Time frame: 6 months
Adverse events
Time frame: 6 months
Adverse events in special subgroups like high ECOG or high bilirubin patients
Time frame: 6 months
Correlations of tumor response and survival with genetic alterations
Time frame: 6 months
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