NCT02619929已完成不适用
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)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- Rate of patients with oral vinorelbine dose increase from ≤60 to ≥80 mg/m² during the course of the study
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of patients with oral vinorelbine dose increase from ≤60 to ≥80 mg/m² during the course of the study
时间窗: 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.
次要结局
- Body weight(Baseline and 8 weeks of treatment)
- Body mass index(Baseline and 8 weeks of treatment)
- Body surface area(Baseline and 8 weeks of treatment)
- ECOG performance status(Baseline and 8 weeks of treatment)
- Treatment regimen(Baseline)
- Treatment changes(8 weeks of treatment)
- Relationships between oral vinorelbine dose increases and patient and disease characteristics(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(Baseline and 8 weeks of treatment)
- Patient's treatment satisfaction(8 weeks of treatment)
- Physician's treatment satisfaction(8 weeks of treatment)
- Adverse drug reactions(8 weeks of treatment)
研究者
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