Clinical trial · Interventional
Intravesical Thermochemotherapy With Mitomycin-c
Intravesical Mitomycin-C With Bladder Wall Hyperthermia in Intermediate and High Risk Non-muscle Invasive Bladder Cancer
NCT03694535CI-TRIAL-00035129completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To investigate effect of intravesical mitomycin-C(MMC) applied with bladder wall thermotherapy system on reccurrence and progression status of intermediate and high risk non muscle invasive 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bladder wall thermotherapy with Mitomycin-c | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bladder wall thermochemotherapy
- description
- Mitomycin-C application with bladder wall thermochemotherapy system after TUR bladder tumor in intermediate and high risk non muscle invasive bladder cancer
- interventionNames
- Drug: bladder wall thermotherapy with Mitomycin-c
Primary outcomes (2)
- measure
- Recurrence
- timeFrame
- From the beginning of thermochemoterapy until the date of first documented recurrence assessed up to 2 years
- description
- recurrence rate of non muscle invasive bladder cancer during or after treatment
- measure
- Progression rate
- timeFrame
- From the beginning of thermochemoterapy until the date of first documented progression assessed up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * newly diagnosed or followed as recurrent intermediate-risk non muscle invasive non muscle invasive bladder cancer according to the criteria of European Association of Urology. * newly diagnosed or followed as recurrent high-risk non muscle invasive non muscle invasive bladder cancer according to the criteria of European Association of Urology. * pathology of urothelial carcinoma Exclusion Criteria: * Low bladder capacity (\<150ml) * increased post voiding residual urine (\>150ml) * untreatable or uncontrollable urinary tract infection * history of urethral stricture * presence of bladder diverticula larger than 1 cm * pathology other than urothelial carcinoma * WHO (World Health Organization) performance status \> 2 * upper urinary tract urothelial carcinoma diagnosis
References
Publications (2)
- BACKGROUNDMoskovitz B, Meyer G, Kravtzov A, Gross M, Kastin A, Biton K, Nativ O. Thermo-chemotherapy for intermediate or high-risk recurrent superficial bladder cancer patients. Ann Oncol. 2005 Apr;16(4):585-9. doi: 10.1093/annonc/mdi124. Epub 2005 Feb 25. PMID 15734775
- BACKGROUNDColombo R, Salonia A, Leib Z, Pavone-Macaluso M, Engelstein D. Long-term outcomes of a randomized controlled trial comparing thermochemotherapy with mitomycin-C alone as adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC). BJU Int. 2011 Mar;107(6):912-8. doi: 10.1111/j.1464-410X.2010.09654.x. Epub 2010 Oct 4. PMID 21029314