Clinical trial · Interventional
Sequential Combination Therapy in Bladder Cancer
The Effects of Sequential Mitomycin and Bacillus Calmette-Guérin Treatment Versus Bacillus Calmette-Guérin Monotherapy in Patients With High Risk Non-Muscle Invasive Bladder Cancer
- 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)
A consecutive series of patients with High Risk Non-Muscle Invasive Bladder Cancer will be enrolled in several centres. The subjects will be assessed for eligibility at the screening visit (Visit 1) three weeks after Trans-Urethral Resection of the Bladder (TURB) and re-TURB prior to randomization and only subjects who fulfil the inclusion criteria will be included. Patients selected for the study, are centrally randomized (randomization is performed at the Sant'Andrea Hospital) to receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with Immucyst (81 mg Connaught strain BCG). Patients in group two received BCG treatment with the same protocol with a 40 mg mitomycin instillation the day before .
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitomycin | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Bacillus Calmette-Guérin
- description
- Patients receive Bacillus Calmette-Guérin induction treatment according to the standard protocol (an instillation once a week for six weeks) with ImmuCyst (81 mg Connaught strain BCG).
- type
- EXPERIMENTAL
- label
- Mytomicin and Bacillus Calmette-Guérin
- description
- Patients received BCG treatment with the same protocol. Intervention will be a 40 mg mitomycin instillation the day before every single BCG instillation
- interventionNames
- Drug: Mitomycin
Primary outcomes (1)
- measure
- Recurrence rate
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with high risk non muscle invasive bladder cancer * High risk of progression (EORTC risk score \> 6) * Males * Signature of Informed Consent * Ability of consent Exclusion Criteria: * Low Risk Non-Muscle Invasive Bladder Cancer * Muscle Invasive Bladder Cancer * Concomitant Urothelial Bladder Cancer in the Upper-Urinary Tract * Previous bladder or prostate surgery * Prostate or bladder radiotherapy * Urinary tract infection * Chronic urinary retention or indwelling catheters * Neurological patients * Previous BCG infections * Previous or current chemotherapy for other kind of cancers * Patients older than 75 * WHO performance status 3-4 * Residual tumour on re-TURB
References
Publications (4)
- BACKGROUNDSolsona E, Madero R, Chantada V, Fernandez JM, Zabala JA, Portillo JA, Alonso JM, Astobieta A, Unda M, Martinez-Pineiro L, Rabadan M, Ojea A, Rodriguez-Molina J, Beardo P, Muntanola P, Gomez M, Montesinos M, Martinez Pineiro JA; Members of Club Urologico Espanol de Tratamiento Oncologico. Sequential combination of mitomycin C plus bacillus Calmette-Guerin (BCG) is more effective but more toxic than BCG alone in patients with non-muscle-invasive bladder cancer in intermediate- and high-risk patients: final outcome of CUETO 93009, a randomized prospective trial. Eur Urol. 2015 Mar;67(3):508-16. doi: 10.1016/j.eururo.2014.09.026. Epub 2014 Oct 6. PMID 25301758
- BACKGROUNDCui J, Wang W, Chen S, Chen P, Yang Y, Guo Y, Zhu Y, Chen F, Shi B. Combination of Intravesical Chemotherapy and Bacillus Calmette-Guerin Versus Bacillus Calmette-Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer: A Systematic Review and Meta-analysis. Medicine (Baltimore). 2016 Jan;95(3):e2572. doi: 10.1097/MD.0000000000002572. PMID 26817914
- BACKGROUNDKaasinen E, Wijkstrom H, Rintala E, Mestad O, Jahnson S, Malmstrom PU. Seventeen-year follow-up of the prospective randomized Nordic CIS study: BCG monotherapy versus alternating therapy with mitomycin C and BCG in patients with carcinoma in situ of the urinary bladder. Scand J Urol. 2016 Oct;50(5):360-8. doi: 10.1080/21681805.2016.1210672. Epub 2016 Aug 15. PMID 27603424
- DERIVEDCicione A, Lombardo R, Nacchia A, Franco A, Simone G, Pastore A, Leonardo C, Franco G, Tubaro A, DE Nunzio C. No clinical benefit from sequential combination of mitomycin C plus bacillus Calmette-Guerin (BCG) than BCG alone in the adjuvant treatment of high risk non muscle invasive bladder cancer: result of a planned interim analysis of a prospective randomized trial. Minerva Urol Nephrol. 2024 Aug;76(4):458-466. doi: 10.23736/S2724-6051.24.05777-X. Epub 2024 Jun 5. PMID 38842053