Clinical trial · Interventional
BCG With or Without Mitomycin in Treating Patients With Bladder Cancer
A Randomized Phase II Trial of Sequential Chemo-Immunotherapy Versus Immunotherapy Alone in Carcinoma in Situ of the Urinary Bladder
- 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 tumor cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with biological therapy may kill more tumor cells. It is not yet known if BCG is more effective with or without mitomycin. PURPOSE: Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with that of BCG alone 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| BCG vaccine | Biological | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| mitomycin C | Drug | Mitomycin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed carcinoma in situ (CIS) of the bladder with urinary cytology * Primary CIS (no prior history of CIS, papillary, or solid transitional cell carcinoma \[TCC\] of the bladder and no concurrent papillary or solid TCC) OR * Secondary CIS (detected after complete resection of superficial Ta/T1 TCC of the bladder) OR * Concurrent CIS (in the presence of superficial primary or recurrent Ta/T1 TCC of the bladder) * No more than 28 days since prior transurethral resection (TUR) of all visible lesions * No muscle involvement * No prior or concurrent upper urinary tract tumors * No urethral strictures that would prevent endoscopic procedures and repeated catheterization * No upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risky PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * No active tuberculosis (highly positive skin tests allowed if no active disease) * No disease that would preclude general anesthesia * No active intractable or uncontrollable infection * No other prior or concurrent malignancy except cured basal cell skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior BCG Chemotherapy: * More than 3 months since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to the pelvis Surgery: * See Disease Characteristics Other: * More than 3 months since prior intravesical cytostatic agents
References
Publications (1)
- RESULTOosterlinck W, Kirkali Z, Sylvester R, da Silva FC, Busch C, Algaba F, Collette S, Bono A. Sequential intravesical chemoimmunotherapy with mitomycin C and bacillus Calmette-Guerin and with bacillus Calmette-Guerin alone in patients with carcinoma in situ of the urinary bladder: results of an EORTC genito-urinary group randomized phase 2 trial (30993). Eur Urol. 2011 Mar;59(3):438-46. doi: 10.1016/j.eururo.2010.11.038. Epub 2010 Dec 7. PMID 21156335