Clinical trial · Interventional
Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT
A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)
NCT03689478CI-TRIAL-00055741I-HIVECcompletedN/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)
This is a prospective single-arm pilot study investigating the safety and feasibility of giving hyperthermic intravesical chemotherapy immediately following transurethral resection of bladder tumour.
Conditions
Conditions (3)
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 |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Hyperthermia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermic intravesical chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperthermic intravesical chemotherapy
- description
- Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour
- interventionNames
- Other: Hyperthermic intravesical chemotherapy
Primary outcomes (1)
- measure
- 30-day complications
- timeFrame
- Thirty days after the experimental treatment
- description
- Complications which occur within 30 days after the experimental treatment
Secondary outcomes (5)
- measure
- Hyperthermic intravesical chemotherapy instillation rate
- timeFrame
- One day after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or above with informed consent Exclusion Criteria: * ECOG performance status ≥2 * ASA 4 or above * History of bleeding disorder * Any use of anti-coagulants * Pregnancy
References
Publications (6)
- BACKGROUNDSylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17. PMID 16442208
- BACKGROUNDBabjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17. PMID 27324428
- BACKGROUNDSchooneveldt G, Bakker A, Balidemaj E, Chopra R, Crezee J, Geijsen ED, Hartmann J, Hulshof MC, Kok HP, Paulides MM, Sousa-Escandon A, Stauffer PR, Maccarini PF. Thermal dosimetry for bladder hyperthermia treatment. An overview. Int J Hyperthermia. 2016 Jun;32(4):417-33. doi: 10.3109/02656736.2016.1156170. Epub 2016 May 1. PMID 27132465
- BACKGROUNDOwusu RA, Abern MR, Inman BA. Hyperthermia as adjunct to intravesical chemotherapy for bladder cancer. Biomed Res Int. 2013;2013:262313. doi: 10.1155/2013/262313. Epub 2013 Sep 1. PMID 24073396
- BACKGROUNDKok HP, Wust P, Stauffer PR, Bardati F, van Rhoon GC, Crezee J. Current state of the art of regional hyperthermia treatment planning: a review. Radiat Oncol. 2015 Sep 17;10:196. doi: 10.1186/s13014-015-0503-8. PMID 26383087
- BACKGROUNDTeicher BA, Kowal CD, Kennedy KA, Sartorelli AC. Enhancement by hyperthermia of the in vitro cytotoxicity of mitomycin C toward hypoxic tumor cells. Cancer Res. 1981 Mar;41(3):1096-9. PMID 7459853