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.
This is a randomized, open-label, active-controlled, prospective, multinational Phase III confirmative study with 2 treatment groups and an adaptive design (Bauer and Köhne, 1994). The study is designed to compare the efficacy of treatment with abnobaVISCUM® 900 with Mitomycin C (MMC). Patients with completely resected superficial bladder carcinoma (Stage Ta) with an intermediate risk classification according to the European Association of Urology (EAU, update 2013) and with one immediately post operative MMC 40 mg or Epirubicin 50 mg intravesical instillation will be eligible for inclusion in the study. The study comprises a screening period of not more than 6 weeks, a treatment period of 12 months for abnobaVISCUM® 900 and MMC and a follow-up period of 12 months. Patients will be screened within 6 weeks after the transurethral resection of the bladder (TURB) and the immediately post operative MMC 40 mg or Epirubicin 50 mg intravesical instillation. A re-resection should be performed before inclusion if indicated. Every patient is to provide written informed consent before any study related procedures will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
548
intravesical instillation of abnobaVISCUM 900 13 times during treatment period
intravesical instillation of Mitomycin C 10 times during treatment period
Theodor Bilharz Research Institute
Giza, Egypt
Clinic of Urology of the University Hospital of Essen
Essen, Germany
Urologische Gemeinschaftspraxis
Heinsberg, Germany
Urologische Praxis
Herzberg, Germany
Time to tumor recurrence
The primary objective of the study is to assess the efficacy of abnobaVISCUM® 900. Primary efficacy criterion will be the time to tumor recurrence.
Time frame: up to two years
Toxicity and tolerability of the study medication
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.
Time frame: up to two years
Prognosis after 1 year for recurrence and progression
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.
Time frame: 1 year
Quality of Life with the EORTC QLQ-C30 and BLS24 Quality of Life Questionnaires
A secondary efficacy endpoint is measurement of Quality of Life with the EORTC QLQ-C30 and BLS24 questionnaires.
Time frame: up to two years
Tumor grading
A secondary efficacy endpoint is the tumor grading in case of a recurrence by cytology, ultrasound, and cystoscopy.
Time frame: up to two years
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Urologische Facharztpraxis
Würselen, Germany