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)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: Vinorelbine oral

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Austria
  • Braunau Am Inn, Austria
  • Graz, Austria
  • Innsbruck, Austria
  • Klagenfurt, Austria
  • Vienna, Austria
  • Villach, Austria
  • Vöcklabruck, Austria
• Germany
  • Aachen, Germany
  • Altoetting, Germany
  • Amberg, Germany
  • Bad Nauheim, Germany
  • Ballenstedt, Germany
  • Berlin, Germany
  • Bielefeld, Germany
  • Chemnitz, Germany
  • Cologne, Germany
  • Dessau, Germany
  • Donauwoerth, Germany
  • Eggenfelden, Germany
  • Erbach, Germany
  • Erfurt, Germany
  • Frankfurt/Main, Germany
  • Goeppingen, Germany
  • Greifswald, Germany
  • Guestrow, Germany
  • Halle/Saale, Germany
  • Hannover, Germany
  • Heppenheim, Germany
  • Homburg, Germany
  • Karlsruhe, Germany
  • Kiel, Germany
  • Kulmbach, Germany
  • Lich, Germany
  • Lostau, Germany
  • Ludwigsburg, Germany
  • Luebeck, Germany
  • Mainz, Germany
  • Mannheim, Germany
  • Marktredwitz, Germany
  • Memmingen, Germany
  • Munich, Germany
  • Münster, Germany
  • Offenbach, Germany
  • Offenburg, Germany
  • Ostfildern, Germany
  • Regensburg, Germany
  • Saarbruecken, Germany
  • Schwandorf, Germany
  • Solingen, Germany
  • Stolberg, Germany
  • Villingen-Schwenningen, Germany
  • Waltershausen, Germany
  • Weinheim, Germany
  • Werdau, Germany
  • Wesel, Germany
  • Winnenden, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pierre Fabre Pharma GmbH
• Collaborators: Winicker Norimed GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Metastatic Breast Cancer; Oral Vinorelbine; Advanced Non-Small-Cell Lung Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Breast Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Vinorelbine
• Other Study ID Numbers: DE2015026