Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria

Overview

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.

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2018

Interventions

  • Drug: Vinorelbine oral

Clinical Trial Outcome Measures

Primary Measures

  • Rate of patients with oral vinorelbine dose increase from ≤60 to ≥80 mg/m² during the course of the study
    • Time Frame: 8 weeks of treatment
    • 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 Measures

  • Body weight
    • Time Frame: Baseline and 8 weeks of treatment
    • Body weight [kg] at baseline and changes during the study
  • Body mass index
    • Time Frame: Baseline and 8 weeks of treatment
    • Body mass index [kg/m^2] at baseline and changes during the study
  • Body surface area
    • Time Frame: Baseline and 8 weeks of treatment
    • Body surface area [m^2] at baseline and changes during the study
  • ECOG performance status
    • Time Frame: Baseline and 8 weeks of treatment
    • ECOG performance status [grades 0-5] at baseline and changes during the study
  • Treatment regimen
    • Time Frame: Baseline
    • Frequency analysis of planned treatment regimens (monotherapy, combination, combination compounds) at baseline. Reasons for choosing the treatment regimen will be analyzed.
  • Treatment changes
    • Time Frame: 8 weeks of treatment
    • Frequency analysis of dose changes and of the underlying reasons
  • Relationships between oral vinorelbine dose increases and patient and disease characteristics
    • Time Frame: Baseline and 8 weeks of treatment
    • Generalized linear mixed model with the variable “dose increase” as binary response variable
  • Assessment of initial tumor response (based on clinical or imaging assessment)
    • Time Frame: 8 weeks of treatment
  • Patient’s quality of life
    • Time Frame: Baseline and 8 weeks of treatment
    • Evaluation of the patient’s quality of life [Short Form (SF)-12]
  • Patient’s treatment satisfaction
    • Time Frame: 8 weeks of treatment
    • Evaluation of the patient’s treatment satisfaction [Cancer Therapy Satisfaction Questionnaire (CTSQ)]
  • Physician’s treatment satisfaction
    • Time Frame: 8 weeks of treatment
    • Evaluation of the physician’s treatment satisfaction [5 point scale]
  • Adverse drug reactions
    • Time Frame: 8 weeks of treatment
    • Evaluation of adverse drug reactions using CTCAE v4.03

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pierre Fabre Pharma GmbH
  • Collaborator
    • Winicker Norimed GmbH
  • Provider of Information About this Clinical Study
    • Sponsor

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