Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Carcinoma

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Vinorelbine

Tubulin Modulators

Antimitotic Agents

Vinorelbine oral

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.

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

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 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.

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

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

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

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

Frequency analysis of planned treatment regimens (monotherapy, combination, combination compounds) at baseline. Reasons for choosing the treatment regimen will be analyzed.

Frequency analysis of dose changes and of the underlying reasons

Generalized linear mixed model with the variable "dose increase" as binary response variable

Evaluation of the patient's quality of life \[Short Form (SF)-12\]

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

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

Evaluation of adverse drug reactions using CTCAE v4.03

Winicker Norimed GmbH

Pierre Fabre Pharma GmbH

Cisplatin

Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.

Observation or maintenance therapy other than orla navelbine.

Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine

Vinorelbine Oral

Zhen Wang, PhD,MD

This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in Patients with advanced Non-Small Cell Lung Cancer.

The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B).

In the 1st stage (Week 1-12), all patients will receive combination chemotherapy, i.e. Platinum and Navelbine, for 4 cycles. The regimen is:

Navelbine oral 60mg/m2 d1,8 the first cycle; oral 80mg/m2 day1,8 in sequential cycles q3w plus cisplatin: 75mg/m2 d1 q3w.

In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no PD will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B). The allocation will be done in sequence at each site, i.e., the first subject who complete the combination chemotherapy with acceptable tolerance and have no PD will be allocated to Arm A, and the second will be allocated to Arm B, and so on. Arm A will continue with oral Navelbine 3 times weekly as maintenance therapy, up to 12 weeks, or till progression, unacceptable toxicity or death occurred. As contrast, Arm B will receive other therapy as per the physician's choice.

Arm A: Navelbine oral 50mg three times per week (Day 1, 3, 5 of each week ) Arm B: Physician's choice (other than Navelbine oral) computed tomography (CT) or magnetic resonance imaging (MRI) will be done at the screening visit, Week 7, Week 13 (before the initiation of maintenance therapy), Week 19 (after 6 weeks of maintenance therapy), and Week 25 (after 12 weeks of maintenance therapy), to evaluate the tumor response. The Disease Control Rate (proportion of patients in complete response (CR), partial response (PR) or stable disease (SD)) after 6 weeks and 12 weeks of maintenance therapy will be evaluated separately for the 2 arms. And Arm B is for observational study only, and will provide rationale for control group selecting in future study.

Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer

A Clinical Study to Investigate the Efficacy and Safety of Combination of Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Patients With Advanced Non-Small Cell Lung Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria	NCT02619929	Non-Small-Cell ... Breast Cancer	Vinorelbine ora...	18 Years -	Pierre Fabre Pharma GmbH
Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer	NCT02985203	Lung Neoplasm M...	Vinorelbine Ora...	18 Years -	Guangdong Association of Clinical Trials
Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer	NCT02985203	Lung Neoplasm M...	Vinorelbine Ora...	18 Years -	Guangdong Association of Clinical Trials
Initial Oral Vinorelbine Dosing Schedules in Clinical Routine in Germany and Austria	NCT02619929	Non-Small-Cell ... Breast Cancer	Vinorelbine ora...	18 Years -	Pierre Fabre Pharma GmbH

Spots Global Cancer Trial Database for vinorelbine oral