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

• Conditions: immunostimulating adjuvant therapy of superficial carcinomas of the urinary bladder; MedDRA version: 8.1Level: LLTClassification code 10046518Term: Urinary bladder carcinoma

• Registration Number: EUCTR2005-001775-35-AT
• Lead Sponsor: medac GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 186

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

- general health status according to WHO score (ECOG) < 2
- patients with lymph node metastasis or other metastasis
- other current malignancies (not including basalioma)
- immunosuppressed patients with congenital or acquired immune deficiencies (e.g. positive HIV serology, leukaemia, lymphoma, corticosteroidal therapy)
- prior BCG treatment
- active tuberculosis
- history of radiotherapy of the bladder
- isolated Cis
- residual urine > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified