Therapeutic Instillation of Mistletoe
Summary
The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM® 900, in particular, to compare the toxicity of the two treatments. Another secondary objective is the treatment efficacy as measured by calculated prognosis for recurrence and progression after 1 year, the tumor grading in case of a recurrence and by measurement of Quality of Life.
Timeline
- Start
- 2015-04
- Primary completion
- 2026-03-24
- Completion
- 2026-04-24
Outcome
Outcome not reported
Stopped (Enrollment): “The study was terminated because the required number of patients cannot be reached in the foreseeable future. Recruitment was not stopped due to safety issues. Follow-up for all patients was completed according protocol including safety monitoring.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mitomycin C | Other / unclassified | — | Other |
| Subject | abnobaVISCUM 900 | Unknown | — | Other |