Clinical trial · Interventional
Biological Therapy in Treating Patients With Bladder Cancer
A Prospective Randomized Trial for the Comparison of Two BCG Strains (Bacille Calmette-Guerin) in the Prophylaxis of Papollary Bladder Tumors Stage Ta and T1 and Treatment of Carcinoma in Situ
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known which type of BCG is more effective for bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different types of BCG in treating patients who have bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Connaught | Biological | — | UNRESOLVED |
| Tice | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- BCG-Connaught
- interventionNames
- Biological: Connaught
- type
- ACTIVE_COMPARATOR
- label
- BCG Onko-Tice
- interventionNames
- Biological: Tice
Primary outcomes (1)
- measure
- Assess role of prior exposition to mycobacteria
- timeFrame
- 6 weeks
Secondary outcomes (1)
- measure
- Define role of fever occurrence as potential indicator for BCG reactivity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed completely resected T1 or Ta papillary tumors of the urinary bladder TaG2 greater than 2 relapses in 2 years TaG3 unifocal or multifocal Unifocal primary T1G2-3 after a histological tumor-free second resection If multiple/multifocal, worst stage and grade AND/OR Histologically and cytologically confirmed primary or secondary carcinoma in situ of the urinary bladder No persistent T1 disease in second resection No contracted bladder (bladder capacity less than 80 mL) or bladder irritation within past 5 years No urothelial carcinoma of the upper urinary tract or the urethra PATIENT CHARACTERISTICS: Age: 18 to 90 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Liver function no greater than 1.5 times upper limit of normal (ULN) Renal: Renal function no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No other concurrent malignancies except basocellular carcinoma No congenital or acquired immunosuppression (e.g., HIV, leukemia, lymphoma, transplant recipient) No uncontrollable or untreated urinary tract infection No chronic recurring bacterial cystitis PRIOR CONCURRENT THERAPY: Biologic therapy: No prior BCG therapy Chemotherapy: At least 3 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 5 years since prior radiotherapy to the bladder Surgery: See Disease Characteristics Other: No prior tuberculostatic therapy No concurrent local antiseptics or antibiotics
References
Publications (1)
- RESULTRentsch CA, Birkhauser FD, Biot C, Gsponer JR, Bisiaux A, Wetterauer C, Lagranderie M, Marchal G, Orgeur M, Bouchier C, Bachmann A, Ingersoll MA, Brosch R, Albert ML, Thalmann GN. Bacillus Calmette-Guerin strain differences have an impact on clinical outcome in bladder cancer immunotherapy. Eur Urol. 2014 Oct;66(4):677-88. doi: 10.1016/j.eururo.2014.02.061. Epub 2014 Mar 12. PMID 24674149