Clinical trial · Observational
Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria
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)
NCT02619929CI-TRIAL-00034639StepUpcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vinorelbine oral | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- 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.
Secondary outcomes (12)
- measure
- Body weight
- timeFrame
- Baseline and 8 weeks of treatment
- description
- Body weight \[kg\] at baseline and changes during the study
- measure
- Body mass index
- timeFrame
- Baseline and 8 weeks of treatment
- description
- Body mass index \[kg/m\^2\] at baseline and changes during the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.