Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria
StepUp
Assessment of Initial Oral Vinorelbine Dosing Schedules Used for the Treatment of Advanced Non-small-cell Lung Cancer and Metastatic Breast Cancer in Clinical Routine in Germany and Austria (StepUp)
1 other identifier
observational
108
2 countries
56
Brief Summary
The aim of this non-interventional study is to assess oral vinorelbine dose schedules (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of treatment under routine conditions in Germany together with the underlying reasons for the respective chosen schedules.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
Typical duration for all trials
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedAugust 29, 2018
August 1, 2018
2.1 years
November 23, 2015
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of patients with oral vinorelbine dose increase from ≤60 to ≥80 mg/m² during the course of the study
The outcome will be calculated together with its negative (i.e. the rate of patients without such dose increase). Reasons for increasing and for not increasing the dose will be analyzed.
8 weeks of treatment
Secondary Outcomes (12)
Body weight
Baseline and 8 weeks of treatment
Body mass index
Baseline and 8 weeks of treatment
Body surface area
Baseline and 8 weeks of treatment
ECOG performance status
Baseline and 8 weeks of treatment
Treatment regimen
Baseline
- +7 more secondary outcomes
Interventions
Eligibility Criteria
Palliative patients with advanced non-small-cell lung cancer (NSCLC, stage III and IV) or anthracycline/taxane-resistant metastatic breast cancer (MBC, stage IV)
You may qualify if:
- Written informed consent of the patient with regard to the pseudonymized documentation and processing of his/her disease data
- Legally capable male or female NSCLC patient or legally capable female MBC patient; in both situations: ≥ 18 years of age (no upper limit)
- Presence of any of the following two tumor entities:
- Advanced NSCLC (stage III or IV)
- Anthracycline- and taxane-resistant MBC (stage IV) in women
- Monotherapy or any combination therapy with oral vinorelbine
You may not qualify if:
- Presence of any contraindication with regard to oral vinorelbine treatment (and with regard to i.v. vinorelbine in case of hybrid-treatment) according to the respective Summary of Product Characteristics (SmPC)
- Oral vinorelbine based palliative treatment already ongoing or planned oral vinorelbine starting dose of \>60 mg/m2
- Presence of a Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 2
- Simultaneous participation in an interventional clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pierre Fabre Pharma GmbHlead
- Winicker Norimed GmbHcollaborator
Study Sites (56)
Unknown Facility
Braunau am Inn, Austria
Unknown Facility
Graz, Austria
Unknown Facility
Innsbruck, Austria
Unknown Facility
Klagenfurt, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Villach, Austria
Unknown Facility
Vöcklabruck, Austria
Unknown Facility
Aachen, Germany
Unknown Facility
Altötting, Germany
Unknown Facility
Amberg, Germany
Unknown Facility
Bad Nauheim, Germany
Unknown Facility
Ballenstedt, Germany
Unknown Facility
Berlin, Germany
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Bielefeld, Germany
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Chemnitz, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Dessau, Germany
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Donauwörth, Germany
Unknown Facility
Eggenfelden, Germany
Unknown Facility
Erbach im Odenwald, Germany
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Erfurt, Germany
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Frankfurt am Main, Germany
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Göppingen, Germany
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Greifswald, Germany
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Güstrow, Germany
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Halle, Germany
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Hanover, Germany
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Heppenheim an der Bergstrasse, Germany
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Homburg, Germany
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Karlsruhe, Germany
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Kiel, Germany
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Kulmbach, Germany
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Lich, Germany
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Lostau, Germany
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Ludwigsburg, Germany
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Lübeck, Germany
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Mainz, Germany
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Mannheim, Germany
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Marktredwitz, Germany
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Memmingen, Germany
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Munich, Germany
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Münster, Germany
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Offenbach, Germany
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Offenburg, Germany
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Ostfildern, Germany
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Regensburg, Germany
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Saarbrücken, Germany
Unknown Facility
Schwandorf in Bayern, Germany
Unknown Facility
Solingen, Germany
Unknown Facility
Stolberg, Germany
Unknown Facility
Villingen-Schwenningen, Germany
Unknown Facility
Waltershausen, Germany
Unknown Facility
Weinheim, Germany
Unknown Facility
Werdau, Germany
Unknown Facility
Wesel, Germany
Unknown Facility
Winnenden, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2015
First Posted
December 2, 2015
Study Start
February 1, 2016
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
August 29, 2018
Record last verified: 2018-08