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| Name | Class |
|---|---|
| Trium Analysis Online GmbH | INDUSTRY |
| mca Berlin | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pts receiving nab-paclitaxel/gemcitabine | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of Life questionnaire | Other | EORTC QLQ-C30 questionnaire |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic pancreatic cancer subject to firstline therapy with nab-paclitaxel and gemcitabine
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| Name | Affiliation | Role |
|---|---|---|
| Salah-Eddin Al-Batran, Prof. Dr. | Institute of Clinical Cancer Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research | Frankfurt | 60488 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33038277 | Derived | Al-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. |
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No IPD will be shared.
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Tumor containing tissues are collected for a translational program focusing on defining prognostic and predictive factors.
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 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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