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Intravesical instillation of BCG strain RIVM versus TICE for prevention of recurrenec in patients with high-risk papillary superficial carcinomas of the urinary bladder. A randomised phase II clinical trial - BCG RIVM vs. BCG TICE in patients with high-risk superficial bladder cancer

Intravesical instillation of BCG strain RIVM versus TICE for prevention of recurrenec in patients with high-risk papillary superficial carcinomas of the urinary bladder. A randomised phase II clinical trial - BCG RIVM vs. BCG TICE in patients with high-risk superficial bladder cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001775-35-AT
Enrollment
186
Registered
2007-05-29
Start date
2007-07-12
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immunostimulating adjuvant therapy of superficial carcinomas of the urinary bladder MedDRA version: 8.1 Level: LLT Classification code 10046518 Term: Urinary bladder carcinoma

Interventions

Trade Name: BCG-medac Product Name: BCG medac Pharmaceutical Form: Solution for intravesical use INN or Proposed INN: none CAS Number: none Current Sponsor code: none Other descriptive name: none Conc

Sponsors

medac GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - histologically confirmed superficial carcinoma of the urinary bladder (high risk tumour, defined as pTa G3, pT1 G2-3, or pTa/pT1 with concomitant Cis; first diagnosis or recurrence) as documented by the reference pathologist - complete resection of all visible lesions by two TUR’s performed under standard visible light conditions - age: 19 years and older - patient’s written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - general health status according to WHO score (ECOG) 50 ml - prosthetic valve - vascular prosthesis - gross haematuria - evidence of urinary infection - pregnancy (planned or existent) / lactation - simultaneous participation in other clinical trials - patients suffering from mental disorders

Design outcomes

Primary

MeasureTime frame
Main Objective: This study is designed to evaluate comparability of BCG strains RIVM and TICE with respect to their efficacy and safety in patients with complete resection of high risk superficial bladder cancer defined as pTa G3, pT1 G2-3, or pTa/pT1 with concomitant Cis;Secondary Objective: - recurrence-free survival rate at 24 and 36 months after randomisation - progression-free survival - incidence of adverse events ;Primary end point(s): - recurrence-free survival rate at 12 months after randomisation Recurrent tumours are all lesions such as papillary tumours (Ta, T1-4), carcinoma in situ and dysplasia as determined by the reference pathologist.—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026