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

Metastatic Pancreatic Cancer Clinical Trial

— QoliXane  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691052
• Other study ID #: QoliXane
• Status: Completed
• Start date: December 2014
• Est. completion date: July 2019

Study information

• Verified date: April 2020
• Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• metastatic pancreatic carcinoma

• no previous therapy in the metastatic stage

• planned firstline therapy with nab-paclitaxel and gemcitabine

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Quality of Life questionnaire
EORTC QLQ-C30 questionnaire

Locations

Country	Name	City	State
Germany	Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research	Frankfurt

Sponsors (3)

Lead Sponsor	Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	mca Berlin, Trium Analysis Online GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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	6 months
Secondary	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	3 and 6 months
Secondary	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	3 months
Secondary	Prognostic validity of Global Health Status/Quality of Life Score as assessed by tumor response and EORTC QLQ-C30		6 months
Secondary	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
Secondary	Influence of Neuropathy on Quality of Life compared to other treatment-related adverse events as assessed by CTCAE v4.0		6 months
Secondary	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
Secondary	Tumor response (RECIST)		6 months
Secondary	Progression free survival as assessed by tumor response		6 months
Secondary	Overall survival as assessed by survival data one year after patient enrollment		1 year
Secondary	Efficacy in high ECOG and high bilirubin patients		6 months
Secondary	Adverse events		6 months
Secondary	Adverse events in special subgroups like high ECOG or high bilirubin patients		6 months
Secondary	Correlations of tumor response and survival with genetic alterations		6 months