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

Breast Cancer Clinical Trial

— StepUp  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619929
• Other study ID #: DE2015026
• Status: Completed
• Start date: February 2016
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Pierre Fabre Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• Vinorelbine oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pierre Fabre Pharma GmbH	Winicker Norimed GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body weight	Body weight [kg] at baseline and changes during the study	Baseline and 8 weeks of treatment
Secondary	Body mass index	Body mass index [kg/m^2] at baseline and changes during the study	Baseline and 8 weeks of treatment
Secondary	Body surface area	Body surface area [m^2] at baseline and changes during the study	Baseline and 8 weeks of treatment
Secondary	ECOG performance status	ECOG performance status [grades 0-5] at baseline and changes during the study	Baseline and 8 weeks of treatment
Secondary	Treatment regimen	Frequency analysis of planned treatment regimens (monotherapy, combination, combination compounds) at baseline. Reasons for choosing the treatment regimen will be analyzed.	Baseline
Secondary	Treatment changes	Frequency analysis of dose changes and of the underlying reasons	8 weeks of treatment
Secondary	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
Secondary	Assessment of initial tumor response (based on clinical or imaging assessment)		8 weeks of treatment
Secondary	Patient's quality of life	Evaluation of the patient's quality of life [Short Form (SF)-12]	Baseline and 8 weeks of treatment
Secondary	Patient's treatment satisfaction	Evaluation of the patient's treatment satisfaction [Cancer Therapy Satisfaction Questionnaire (CTSQ)]	8 weeks of treatment
Secondary	Physician's treatment satisfaction	Evaluation of the physician's treatment satisfaction [5 point scale]	8 weeks of treatment
Secondary	Adverse drug reactions	Evaluation of adverse drug reactions using CTCAE v4.03	8 weeks of treatment