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

Sponsor

Pierre Fabre Pharma GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT02619929

Collaborator

Winicker Norimed GmbH (Industry)

108

Enrollment

Locations

24.9

Actual Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Cancer Breast Cancer	Drug: Vinorelbine oral

Study Design

Study Type:

Observational

Actual Enrollment :

108 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Outcome Measures

Primary Outcome Measures

Rate of patients with oral vinorelbine dose increase from ≤60 to ≥80 mg/m² during the course of the study [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 Outcome Measures

Body weight [Baseline and 8 weeks of treatment]
Body weight [kg] at baseline and changes during the study
Body mass index [Baseline and 8 weeks of treatment]
Body mass index [kg/m^2] at baseline and changes during the study
Body surface area [Baseline and 8 weeks of treatment]
Body surface area [m^2] at baseline and changes during the study
ECOG performance status [Baseline and 8 weeks of treatment]
ECOG performance status [grades 0-5] at baseline and changes during the study
Treatment regimen [Baseline]
Frequency analysis of planned treatment regimens (monotherapy, combination, combination compounds) at baseline. Reasons for choosing the treatment regimen will be analyzed.
Treatment changes [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 [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) [8 weeks of treatment]
Patient's quality of life [Baseline and 8 weeks of treatment]
Evaluation of the patient's quality of life [Short Form (SF)-12]
Patient's treatment satisfaction [8 weeks of treatment]
Evaluation of the patient's treatment satisfaction [Cancer Therapy Satisfaction Questionnaire (CTSQ)]
Physician's treatment satisfaction [8 weeks of treatment]
Evaluation of the physician's treatment satisfaction [5 point scale]
Adverse drug reactions [8 weeks of treatment]
Evaluation of adverse drug reactions using CTCAE v4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	Country
1	Braunau Am Inn	Austria
2	Graz	Austria
3	Innsbruck	Austria
4	Klagenfurt	Austria
5	Vienna	Austria
6	Villach	Austria
7	Vöcklabruck	Austria
8	Aachen	Germany
9	Altoetting	Germany
10	Amberg	Germany
11	Bad Nauheim	Germany
12	Ballenstedt	Germany
13	Berlin	Germany
14	Bielefeld	Germany
15	Chemnitz	Germany
16	Cologne	Germany
17	Dessau	Germany
18	Donauwoerth	Germany
19	Eggenfelden	Germany
20	Erbach	Germany
21	Erfurt	Germany
22	Frankfurt/Main	Germany
23	Goeppingen	Germany
24	Greifswald	Germany
25	Guestrow	Germany
26	Halle/Saale	Germany
27	Hannover	Germany
28	Heppenheim	Germany
29	Homburg	Germany
30	Karlsruhe	Germany
31	Kiel	Germany
32	Kulmbach	Germany
33	Lich	Germany
34	Lostau	Germany
35	Ludwigsburg	Germany
36	Luebeck	Germany
37	Mainz	Germany
38	Mannheim	Germany
39	Marktredwitz	Germany
40	Memmingen	Germany
41	Munich	Germany
42	Münster	Germany
43	Offenbach	Germany
44	Offenburg	Germany
45	Ostfildern	Germany
46	Regensburg	Germany
47	Saarbruecken	Germany
48	Schwandorf	Germany
49	Solingen	Germany
50	Stolberg	Germany
51	Villingen-Schwenningen	Germany
52	Waltershausen	Germany
53	Weinheim	Germany
54	Werdau	Germany
55	Wesel	Germany
56	Winnenden	Germany