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

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Other: Quality of Life questionnaire

• Registration Number: NCT02691052
• Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-25
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pts receiving nab-paclitaxel/gemcitabine	Quality of Life questionnaire	Patients with metastatic pancreatic cancer undergoing a firstline therapy with nab-paclitaxel and gemcitabine will be asked to fill in an EORTC QLQ-C30 questionnaire and an additional questionnaire on worries about quality of life impairments every 4 weeks. No further intervention.

Primary Outcome Measures

Name	Time	Method
Global Health Status/Quality of Life Score at 3 months	3 months	Rate of patients without deterioration of their global health status/quality of life score according to EORTC QLQ-C30 after 3 months

Secondary Outcome Measures

Name	Time	Method
Therapy effects on Global Health Status/Quality of Life Score	3 months	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
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
Adverse events	6 months
Global Health Status/Quality of Life Score at 6 months	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
Limited Baseline Condition	3 and 6 months	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
Progression free survival as assessed by tumor response	6 months
Efficacy in high ECOG and 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
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
Influence of Neuropathy on Quality of Life compared to other treatment-related adverse events as assessed by CTCAE v4.0	6 months
Correlations of tumor response and survival with genetic alterations	6 months

Trial Locations

Locations (1)

Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research; 🇩🇪 Frankfurt, Germany