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| Name | Class |
|---|---|
| Winicker Norimed GmbH | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinorelbine oral | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight [kg] at baseline and changes during the study | Baseline and 8 weeks of treatment |
| Body mass index | Body mass index [kg/m^2] at baseline and changes during the study |
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Inclusion Criteria:
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:
Planned systemic chemotherapy and planned regimen with oral vinorelbine in any palliative setting (decision on treatment must have been made before inclusion in this study); included treatments:
Exclusion Criteria:
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Palliative patients with advanced non-small-cell lung cancer (NSCLC, stage III and IV) or anthracycline/taxane-resistant metastatic breast cancer (MBC, stage IV)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Braunau am Inn | Austria | |||||
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| Baseline and 8 weeks of treatment |
| Body surface area | Body surface area [m^2] at baseline and changes during the study | Baseline and 8 weeks of treatment |
| ECOG performance status | ECOG performance status [grades 0-5] at baseline and changes during the study | Baseline and 8 weeks of treatment |
| Treatment regimen | Frequency analysis of planned treatment regimens (monotherapy, combination, combination compounds) at baseline. Reasons for choosing the treatment regimen will be analyzed. | Baseline |
| Treatment changes | Frequency analysis of dose changes and of the underlying reasons | 8 weeks of treatment |
| Relationships between oral vinorelbine dose increases and patient and disease characteristics | Generalized linear mixed model with the variable "dose increase" as binary response variable | Baseline and 8 weeks of treatment |
| Assessment of initial tumor response (based on clinical or imaging assessment) | 8 weeks of treatment |
| Patient's quality of life | Evaluation of the patient's quality of life [Short Form (SF)-12] | Baseline and 8 weeks of treatment |
| Patient's treatment satisfaction | Evaluation of the patient's treatment satisfaction [Cancer Therapy Satisfaction Questionnaire (CTSQ)] | 8 weeks of treatment |
| Physician's treatment satisfaction | Evaluation of the physician's treatment satisfaction [5 point scale] | 8 weeks of treatment |
| Adverse drug reactions | Evaluation of adverse drug reactions using CTCAE v4.03 | 8 weeks of treatment |
| Graz |
| Austria |
| Innsbruck | Austria |
| Klagenfurt | Austria |
| Vienna | Austria |
| Villach | Austria |
| Vöcklabruck | Austria |
| Aachen | Germany |
| Altötting | Germany |
| Amberg | Germany |
| Bad Nauheim | Germany |
| Ballenstedt | Germany |
| Berlin | Germany |
| Bielefeld | Germany |
| Chemnitz | Germany |
| Cologne | Germany |
| Dessau | Germany |
| Donauwörth | Germany |
| Eggenfelden | Germany |
| Erbach im Odenwald | Germany |
| Erfurt | Germany |
| Frankfurt am Main | Germany |
| Göppingen | Germany |
| Greifswald | Germany |
| Güstrow | Germany |
| Halle | Germany |
| Hanover | Germany |
| Heppenheim an der Bergstrasse | Germany |
| Homburg | Germany |
| Karlsruhe | Germany |
| Kiel | Germany |
| Kulmbach | Germany |
| Lich | Germany |
| Lostau | Germany |
| Ludwigsburg | Germany |
| Lübeck | Germany |
| Mainz | Germany |
| Mannheim | Germany |
| Marktredwitz | Germany |
| Memmingen | Germany |
| Munich | Germany |
| Münster | Germany |
| Offenbach | Germany |
| Offenburg | Germany |
| Ostfildern | Germany |
| Regensburg | Germany |
| Saarbrücken | Germany |
| Schwandorf in Bayern | Germany |
| Solingen | Germany |
| Stolberg | Germany |
| Villingen-Schwenningen | Germany |
| Waltershausen | Germany |
| Weinheim | Germany |
| Werdau | Germany |
| Wesel | Germany |
| Winnenden | Germany |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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