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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00003890 |
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Date of registration:
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30/04/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public 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
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Scientific 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 - JONAS-1 |
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Date of first enrolment:
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Target sample size:
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200 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00003890 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malignant neoplasm of bladder
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Transitional Cell Carcinoma
C67
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Primary Outcome(s)
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- Side effects according to NCI-CTCAE v3.0 and treatment conditions in daily routine; time frame: 9 months after LPI
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Secondary Outcome(s)
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- Explorative assessment of Overall Response Rate (ORR); time frame: 9 months after LPI
- Anti-emetic comedication; time frame: 9 months after LPI
- Anti-obstipative diet / comedication; time frame: 9 months after LPI
- General well-being / quality of life of the patients (patient questionnaire); time frame: 9 months after LPI
- Patients' satisfaction with the treatment (patient questionnaire); time frame: 9 months after LPI
- Physicians' satisfaction with the treatment; time frame: 9 months after LPI
- Patients' compliance with regards to the cotreatments (patient questionnaire); time frame: 9 months after LPI
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Secondary ID(s)
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JONAS-1
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NCT01103544
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Source(s) of Monetary Support
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Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Ethics review
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Status:
Approval date:
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