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Completed

NCT Number: NCT02619929

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

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.

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Key information

Conditions

Non-Small-Cell Lung Cancer Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Braunau am Inn, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vinorelbine oral

Drug

Primary outcomes

  1. 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 outcomes

  1. Body weight

    Time frame: Baseline and 8 weeks of treatment

    Body weight [kg] at baseline and changes during the study

  2. Body mass index

    Time frame: Baseline and 8 weeks of treatment

    Body mass index [kg/m^2] at baseline and changes during the study

  3. Body surface area

    Time frame: Baseline and 8 weeks of treatment

    Body surface area [m^2] at baseline and changes during the study

  4. ECOG performance status

    Time frame: Baseline and 8 weeks of treatment

    ECOG performance status [grades 0-5] at baseline and changes during the study

  5. 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.

  6. Treatment changes

    Time frame: 8 weeks of treatment

    Frequency analysis of dose changes and of the underlying reasons

  7. 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

  8. Assessment of initial tumor response (based on clinical or imaging assessment)

    Time frame: 8 weeks of treatment

  9. 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]

  10. Patient's treatment satisfaction

    Time frame: 8 weeks of treatment

    Evaluation of the patient's treatment satisfaction [Cancer Therapy Satisfaction Questionnaire (CTSQ)]

  11. Physician's treatment satisfaction

    Time frame: 8 weeks of treatment

    Evaluation of the physician's treatment satisfaction [5 point scale]

  12. Adverse drug reactions

    Time frame: 8 weeks of treatment

    Evaluation of adverse drug reactions using CTCAE v4.03

Sponsors and collaborators

Lead sponsor

Pierre Fabre Pharma GmbH

Industry

Collaborators

  • Winicker Norimed GmbH

Registry information

Official study 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)

Acronym: StepUp

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2015
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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