Male and female patients aged ≥ 18 to ≤ 85 years with a completely resected superficial bladder cancer (Stage Ta tumors) with a classification of intermediate-risk according to the EAU and without CIS and/or G3 tumors after a TURB and one immediately post-operative intravesical instillation of MMC 40 mg or epirubicin 50 mg (only Poland).
Conditions
Brief summary
The primary endpoint of the study will be the time to tumor recurrence. Should a recurrence of the bladder carcinoma be recorded, the patient will be withdrawn from study treatment.
Detailed description
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., Secondary efficacy endpoints: prognosis after 1 year for recurrence and progression, estimated by the European Organization for Research and Treatment of Cancer (EORTC) Bladder Cancer Calculator, tumor grading, Quality of Life (EORTC QLQ-C30 and BLS24)
Interventions
DRUGabnobaVISCUM Fraxini 20 mg Injektionslösung Wirkstoff: Auszug aus frischem Eschenmistelkraut
DRUGMITOMYCIN
Sponsors
Abnoba GmbH, Abnoba GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study will be the time to tumor recurrence. Should a recurrence of the bladder carcinoma be recorded, the patient will be withdrawn from study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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., Secondary efficacy endpoints: prognosis after 1 year for recurrence and progression, estimated by the European Organization for Research and Treatment of Cancer (EORTC) Bladder Cancer Calculator, tumor grading, Quality of Life (EORTC QLQ-C30 and BLS24) | — |
Countries
Germany
Outcome results
None listed