Clinical trial · Interventional
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
A Randomized Controlled Study Comparing Adjuvant Hyperthermia Treatment in Conjunction With Mitomycin C Versus BCG Immunotherapy (BCG) Adjuvant Treatment in Patients With Superficial Transitional Cell Carcinoma of the Bladder (STCCB)
NCT00384891CI-TRIAL-00015795terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer: 1. A combination of bladder wall heating and local chemotherapy (Synergo) 2. Bacillus Calmette-Guérin (BCG)
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor of Urinary Bladder | Malignant Bladder Neoplasm | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Urinary Bladder Cancer | Malignant Bladder Neoplasm | ALIAS | 0.90 |
| Urinary Bladder Diseases | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
| Urologic Diseases | — | UNRESOLVED | — |
| Urologic Neoplasms | Urinary Tract Neoplasm | ALIAS |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacillus Calmette-Guérin | Drug | — | UNRESOLVED |
| Synergo + MMC | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Synergo + MMC
- description
- Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
- interventionNames
- Device: Synergo + MMC
- type
- ACTIVE_COMPARATOR
- label
- Bacillus Calmette-Guérin
- description
- Intravesical instillation with BCG (Bacillus Calmette-Guérin)
- interventionNames
- Drug: Bacillus Calmette-Guérin
Primary outcomes (1)
- measure
- Recurrence free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Superficial TCC: Any G3 or any T1 and/or CIS * Multifocal (\>1) Ta lesions * Multiple recurrences (\>2) of Ta lesions in the last 24 months * Complete tumor eradication must be confirmed * WHO performance status 0-2 (Appendix V) * Life expectancy of more than 24 months * Patients willing to sign informed consent Exclusion Criteria: * Bladder tumors other than TCC * Coexistence of another primary malignant tumor other than BCC of the skin * TCC of the bladder involving the urethra or upper urinary tract * Previous history of TCC stage T2 or higher * Clinical presence or previous history of regional spreading or distant metastases * Intravesical MMC treatments during the last 12 months * Previous intravesical BCG therapy (Any intravesical BCG therapy in the last 24 months, or More than 6 BCG intravesical instillations in the last 48 months. * Previous pelvic radiotherapy or systemic chemotherapy * Partial cystectomy * Diverticle of bladder larger than 1cm in diameter * Residual urine \> 100cc measured by uroflowmetry * Bladder volume \< 150cc measured by ultrasound * Urinary incontinence (more than one wet pad a day) * Urethral stricture impeding 20F catheterization * Urethral bleeding or persistent hematuria * Active intractable or uncontrollable UTI * Active tuberculosis or BCG infection * Patients who experienced BCG life threatening sepsis * Known allergy to MMC or BCG * Known impaired immune response, positive HIV serology, patients receiving systemic steroids or immunosuppressive therapy * Hematological disorders; leukocytes \< 3500, platelets \< 100,000 * Kidney or liver function disorders (more than 1.5 times upper normal limit) * Pregnant or lactating women * Patients who cannot be followed up properly or are unable to collaborate
References
Publications (1)
- DERIVEDArends TJ, Nativ O, Maffezzini M, de Cobelli O, Canepa G, Verweij F, Moskovitz B, van der Heijden AG, Witjes JA. Results of a Randomised Controlled Trial Comparing Intravesical Chemohyperthermia with Mitomycin C Versus Bacillus Calmette-Guerin for Adjuvant Treatment of Patients with Intermediate- and High-risk Non-Muscle-invasive Bladder Cancer. Eur Urol. 2016 Jun;69(6):1046-52. doi: 10.1016/j.eururo.2016.01.006. Epub 2016 Jan 20. PMID 26803476