Clinic of Urology of the University Hospital of Essen 45122 Essen (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Jochen Hess, Prof. Dr. Phone: +49 201 7233260» Ansprechpartner anzeigenUrologische Gemeinschaftspraxis 52525 Heinsberg (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Aloys Lappenküper Phone: +49 2452 3113» Ansprechpartner anzeigenUrologische Praxis 37412 Herzberg (Niedersachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Thorsten Werner, Dr. Phone: +49 5521 71212» Ansprechpartner anzeigen
Urologische Facharztpraxis 52146 Würselen (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Thomas Pulte, Dr. Phone: +49 2405 452680» Ansprechpartner anzeigenTheodor Bilharz Research Institute 12411 Giza EgyptRekrutierend» Google-Maps Ansprechpartner: Tarek El Leithy, Prof. Dr. Phone: +2 01222117206» Ansprechpartner anzeigen
1. Time to tumor recurrence (Time Frame - up to two years): The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900. Primary efficacy criterion will be the time to tumor recurrence.
Secondary outcome:
1. Toxicity and tolerability of the study medication (Time Frame - up to two years): The secondary objective, namely safety including toxicity and tolerability of the study medication, will be assessed by the monitoring of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE), laboratory assessments (hematology, biochemistry and urinalysis) and a global judgment of tolerability.
2. Prognosis after 1 year for recurrence and progression (Time Frame - 1 year): A secondary efficacy endpoint is prognosis after 1 year for recurrence and progression, estimated by the European Organization for Research and Treatment of Cancer (EORTC) Bladder Cancer Calculator.
3. Quality of Life with the EORTC QLQ-C30 and BLS24 Quality of Life Questionnaires (Time Frame - up to two years): A secondary efficacy endpoint is measurement of Quality of Life with the EORTC QLQ-C30 and BLS24 questionnaires.
4. Tumor grading (Time Frame - up to two years): A secondary efficacy endpoint is the tumor grading in case of a recurrence by cytology, ultrasound, and cystoscopy.
abnobaVISCUM 900 (viscum album extract / mistletoe extract / abnobaVISCUM / ): intravesical instillation of abnobaVISCUM 900 13 times during treatment period
Mitomycin C (MMC / Mitomycin / ): intravesical instillation of Mitomycin C 10 times during treatment period
Quelle: ClinicalTrials.gov
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"Therapeutic Instillation of Mistletoe"
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