Non-Small-Cell Lung CancerStepUpNCT02619929
Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria
An observational study of Non-Small-Cell Lung Cancer and Breast Cancer, run by Pierre Fabre Pharma GmbH at 56 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer, Breast Cancer
- What is being tested?
- Vinorelbine oral
- Type of treatment
- Pill or oral medicine
- How many people
- 108 participants
- Where
- 56 sitesin 2 countries
- Study dates
- Feb 2016to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
56 sites in 2 countries.
56 sites in 2 countries
Germany49 sites
Study site
Aachen
Study site
Altötting
Study site
Amberg
Study site
Bad Nauheim
Study site
Ballenstedt
Study site
Berlin
Study site
Bielefeld
Study site
Chemnitz
Study site
Cologne
Study site
Dessau
Study site
Donauwörth
Study site
Eggenfelden
Study site
Erbach im Odenwald
Study site
Erfurt
Study site
Frankfurt am Main
Study site
Göppingen
Study site
Greifswald
Study site
Güstrow
Study site
Halle
Study site
Hanover
Study site
Heppenheim an der Bergstrasse
Study site
Homburg
Study site
Karlsruhe
Study site
Kiel
Study site
Kulmbach
Study site
Lich
Study site
Lostau
Study site
Lübeck
Study site
Ludwigsburg
Study site
Mainz
Study site
Mannheim
Study site
Marktredwitz
Study site
Memmingen
Study site
Munich
Study site
Münster
Study site
Offenbach
Study site
Offenburg
Study site
Ostfildern
Study site
Regensburg
Study site
Saarbrücken
Study site
Schwandorf in Bayern
Study site
Solingen
Study site
Stolberg
Study site
Villingen-Schwenningen
Study site
Waltershausen
Study site
Weinheim
Study site
Werdau
Study site
Wesel
Study site
Winnenden
Austria7 sites
Study site
Braunau am Inn
Study site
Graz
Study site
Innsbruck
Study site
Klagenfurt
Study site
Vienna
Study site
Villach
Study site
Vöcklabruck
About this study
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)
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
- Non-Small-Cell Lung Cancer, Breast Cancer
- Being tested
- Vinorelbine oral
- Keywords
- Oral Vinorelbine, Advanced Non-Small-Cell Lung Cancer, Metastatic Breast Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinorelbine oralDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks of treatment
Secondary outcomes (12)
Body weight
Body weight [kg] at baseline and changes during the study
Measured: Baseline and 8 weeks of treatment
Body mass index
Body mass index [kg/m^2] at baseline and changes during the study
Measured: Baseline and 8 weeks of treatment
Body surface area
Body surface area [m^2] at baseline and changes during the study
Measured: Baseline and 8 weeks of treatment
ECOG performance status
ECOG performance status [grades 0-5] at baseline and changes during the study
Measured: 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.
Measured: Baseline
Treatment changes
Frequency analysis of dose changes and of the underlying reasons
Measured: 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
Measured: Baseline and 8 weeks of treatment
Assessment of initial tumor response (based on clinical or imaging assessment)
Measured: 8 weeks of treatment
Patient's quality of life
Evaluation of the patient's quality of life [Short Form (SF)-12]
Measured: Baseline and 8 weeks of treatment
Patient's treatment satisfaction
Evaluation of the patient's treatment satisfaction [Cancer Therapy Satisfaction Questionnaire (CTSQ)]
Measured: 8 weeks of treatment
Physician's treatment satisfaction
Evaluation of the physician's treatment satisfaction [5 point scale]
Measured: 8 weeks of treatment
Adverse drug reactions
Evaluation of adverse drug reactions using CTCAE v4.03
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619929
- Sponsor's protocol ID
- DE2015026
- Acronym
- StepUp
- Status last verified
- Aug 2018
- First submitted
- 23 Nov 2015
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02619929
- Acronym / sponsor ID
- StepUp / DE2015026
- Conditions
- Non-Small-Cell Lung Cancer, Breast Cancer
- Keywords
- Oral Vinorelbine, Advanced Non-Small-Cell Lung Cancer, Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Pierre Fabre Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (8 listed)
- 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:
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vinorelbine oral | Drug | – |
Primary outcome
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.
12 secondary outcomes
Body weight
Time frame: Baseline and 8 weeks of treatment
Body mass index
Time frame: Baseline and 8 weeks of treatment
Body surface area
Time frame: Baseline and 8 weeks of treatment
ECOG performance status
Time frame: Baseline and 8 weeks of treatment
Treatment regimen
Time frame: Baseline
Treatment changes
Time frame: 8 weeks of treatment
Relationships between oral vinorelbine dose increases and patient and disease characteristics
Time frame: Baseline and 8 weeks of treatment
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
Patient's treatment satisfaction
Time frame: 8 weeks of treatment
Physician's treatment satisfaction
Time frame: 8 weeks of treatment
Adverse drug reactions
Time frame: 8 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
56 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small-Cell Lung Cancer and Breast Cancer, run by Pierre Fabre Pharma GmbH at 56 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.