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

Study Overview
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Brief Summary
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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.

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

Conditions
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Metastatic Pancreatic Cancer

Intervention / Treatment
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* Other: Quality of Life questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pts receiving nab-paclitaxel/gemcitabine<br>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. | Other: Quality of Life questionnaire<br>* EORTC QLQ-C30 questionnaire<br>* Other names: EORTC QLQ-C30;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, pancreatic cancer