Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of Life questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pts receiving nab-paclitaxel/gemcitabine
- description
- 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.
- interventionNames
- Other: Quality of Life questionnaire
Primary outcomes (1)
- measure
- Global Health Status/Quality of Life Score at 3 months
- timeFrame
- 3 months
- description
- Rate of patients without deterioration of their global health status/quality of life score according to EORTC QLQ-C30 after 3 months
Secondary outcomes (14)
- measure
- Global Health Status/Quality of Life Score at 6 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAl-Batran SE, Hofheinz RD, Reichart A, Pauligk C, Schonherr C, Schlag R, Siegler G, Dorfel S, Koenigsmann M, Zahn MO, Schubert J, Aldaoud A, Hoffkes HG, Schulz H, Hahn L, Uhlig J, Blau W, Stauch M, Weniger J, Wolf M, Jacobasch L, Bildat S, Wehmeyer J, Homann N, Trojan J, Waidmann O, Fietz T, Feustel HP, Groschek M, Wierecky J, Waibel K, Mahlmann S, Schwindel U, Peters U, Schuch G, Pink D, Eschenburg H, Worns MA, Harich HD, von Weikersthal LF, Dassler KU, Behringer DM, Messmann H, Kretzschmar A, Gallmeier E, Forstbauer H, Kunzmann V, Papke J, Buchner-Steudel P, Vehling-Kaiser U, Springfeld C, Vogel A, Ettrich TJ, Schaaf M, Hausen GZ, Gotze TO; Arbeitsgemeinschaft Internistische Onkologie (AIO). Quality of life and outcome of patients with metastatic pancreatic cancer receiving first-line chemotherapy with nab-paclitaxel and gemcitabine: Real-life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry. Int J Cancer. 2021 Mar 15;148(6):1478-1488. doi: 10.1002/ijc.33336. Epub 2020 Oct 23. PMID 33038277