JAVLOR® Online Non-Interventional Trial

Study Overview
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Brief Summary
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Documentation of data concerning tolerability and efficacy of the intravenous treatment with vinflunine performed under daily routine conditions in Germany. The trial focusses on tolerability including the assessment of the usage of anti-emetic and anti-obstipative concomitant treatment as well as on the efficacy of the treatment.

Official Title
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Usage of Vinflunine i.v. (JAVLOR®) for the Treatment of Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium in Adult Patients After Failure of a Cisplatinum-containing Therapy

Conditions
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Transitional Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Legally competent male and female patients Advanced or metastatic transitional cell carcinoma of the urothelium Failure of a prior Cisplatinum-containing treatment Performance Status 0 or 1 Signed patient informed consent Exclusion Criteria: Missing signed patient informed consent Performance Status 2 or higher Life expectancy < 2 months Brain metastases Creatinine-clearance < 20 ml/min Child-Pugh-stadium C Prothrombin time < 50% Bilirubin > 5 x ULN Transaminases > 6 x ULN Gamma-Glutamyl-transferase > 15 x ULN Pregnant or breast-feeding women Known/suspected hypersensitivity against vinflunine or other vinca-alkaloids Recent (within the last 2 weeks) or current severe infections Baseline ANC < 1,500/mm3 or platelets < 100,000/mm3 Patients being institutionalised due to court/regulatory order

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with advanced / metastatic TCCU after CDDP-failure<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine |  | 9 months after LPI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explorative assessment of Overall Response Rate (ORR) |  | 9 months after LPI | 
| Anti-emetic comedication |  | 9 months after LPI | 
| Anti-obstipative diet / comedication |  | 9 months after LPI | 
| General well-being / quality of life of the patients (patient questionnaire) |  | 9 months after LPI | 
| Patients' satisfaction with the treatment (patient questionnaire) |  | 9 months after LPI | 
| Physicians' satisfaction with the treatment |  | 9 months after LPI | 
| Patients' compliance with regards to the cotreatments (patient questionnaire) |  | 9 months after LPI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TCCU, advanced TCCU, metastatic TCCU, transitional cell carcinoma of the urothelium, advanced transitional cell carcinoma of the urothelium, metastatic transitional cell carcinoma of the urothelium, Cisplatinum failure, Vinflunine, Javlor, daily routine, concomitant antiemetic treatment, concomitant antiobstipative treatment, concomitant antiobstipative diet, patient compliance, quality of life, non-interventional study, Germany, Advanced / metastatic TCCU after Cisplatinum-failure