NCT02691052

Observational Study on Quality of Life of Patients Receiving Nab-paclitaxel/Gemcitabine First Line Therapy, Including a Translational Program

Non-interventional Study on Quality of Life, Efficacy and Tolerability of Nab-paclitaxel/Gemcitabine Firstline Therapy in Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
OTHER	Quality of Life questionnaire	EORTC QLQ-C30 questionnaire

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2016-02-25
• Last updated: 2020-04-21

Locations

1 site across 1 country: Germany