Observational Study on Quality of Life of Patients Receiving Nab-paclitaxel/Gemcitabine First Line Therapy, Including a Translational Program
NCT ID: NCT02691052
Last Updated: 2020-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2014-12-31
2019-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
Quality of Life questionnaire
EORTC QLQ-C30 questionnaire
Interventions
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Quality of Life questionnaire
EORTC QLQ-C30 questionnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* no previous therapy in the metastatic stage
* planned firstline therapy with nab-paclitaxel and gemcitabine
Exclusion Criteria
* patient unable to understand the study and to give informed consent
* patient unable to answer quality of life questionnaires
18 Years
ALL
No
Sponsors
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Trium Analysis Online GmbH
INDUSTRY
mca Berlin
UNKNOWN
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
OTHER
Responsible Party
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Principal Investigators
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Salah-Eddin Al-Batran, Prof. Dr.
Role: STUDY_DIRECTOR
Institute of Clinical Cancer Research
Locations
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Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research
Frankfurt, , Germany
Countries
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References
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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.
Other Identifiers
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QoliXane
Identifier Type: -
Identifier Source: org_study_id
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