Clinical trial NCT02619929: Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small-Cell Lung Cancer
Breast Cancer
Keywords: Oral Vinorelbine
Advanced Non-Small-Cell Lung Cancer
Metastatic Breast Cancer
Lead sponsor: Pierre Fabre Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: Winicker Norimed GmbH
First posted: 2015-12-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Palliative patients with advanced non-small-cell lung cancer (NSCLC, stage III and IV) or anthracycline/taxane-resistant metastatic breast cancer (MBC, stage IV)

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.


Eligibility criteria: 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:

  * Advanced NSCLC (stage III or IV)
  * Anthracycline- and taxane-resistant MBC (stage IV) in women
* 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:

  * Monotherapy or any combination therapy with oral vinorelbine
  * Inclusion of patients with hybrid-treatment involving i.v. and oral vinorelbine in one treatment cycle is allowed

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of patients with oral vinorelbine dose increase from ≤60 to ≥80 mg/m² during the course of the study
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: Body weight
timeFrame: Baseline and 8 weeks of treatment
measure: Body mass index
timeFrame: Baseline and 8 weeks of treatment
measure: Body surface area
timeFrame: Baseline and 8 weeks of treatment
measure: ECOG performance status
timeFrame: Baseline and 8 weeks of treatment
measure: Treatment regimen
timeFrame: Baseline
measure: Treatment changes
timeFrame: 8 weeks of treatment
measure: Relationships between oral vinorelbine dose increases and patient and disease characteristics
timeFrame: Baseline and 8 weeks of treatment
measure: Assessment of initial tumor response (based on clinical or imaging assessment)
timeFrame: 8 weeks of treatment
measure: Patient's quality of life
timeFrame: Baseline and 8 weeks of treatment
measure: Patient's treatment satisfaction
timeFrame: 8 weeks of treatment
measure: Physician's treatment satisfaction
timeFrame: 8 weeks of treatment
measure: Adverse drug reactions
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Braunau Am Inn
country: Austria
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Klagenfurt
country: Austria
city: Vienna
country: Austria
city: Villach
country: Austria
city: Vöcklabruck
country: Austria
city: Aachen
country: Germany
city: Altoetting
country: Germany
city: Amberg
country: Germany
city: Bad Nauheim
country: Germany
city: Ballenstedt
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Chemnitz
country: Germany
city: Cologne
country: Germany
city: Dessau
country: Germany
city: Donauwoerth
country: Germany
city: Eggenfelden
country: Germany
city: Erbach
country: Germany
city: Erfurt
country: Germany
city: Frankfurt/Main
country: Germany
city: Goeppingen
country: Germany
city: Greifswald
country: Germany
city: Guestrow
country: Germany
city: Halle/Saale
country: Germany
city: Hannover
country: Germany
city: Heppenheim
country: Germany
city: Homburg
country: Germany
city: Karlsruhe
country: Germany
city: Kiel
country: Germany
city: Kulmbach
country: Germany
city: Lich
country: Germany
city: Lostau
country: Germany
city: Ludwigsburg
country: Germany
city: Luebeck
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: Marktredwitz
country: Germany
city: Memmingen
country: Germany
city: Munich
country: Germany
city: Münster
country: Germany
city: Offenbach
country: Germany
city: Offenburg
country: Germany
city: Ostfildern
country: Germany
city: Regensburg
country: Germany
city: Saarbruecken
country: Germany
city: Schwandorf
country: Germany
city: Solingen
country: Germany
city: Stolberg
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Waltershausen
country: Germany
city: Weinheim
country: Germany
city: Werdau
country: Germany
city: Wesel
country: Germany
city: Winnenden
country: Germany
Study officials:
References: