Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT

Bladder Cancer Clinical Trial

— I-HIVEC  

Official title:

A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689478
• Other study ID #: CRE Ref. No. 2018.206
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: December 7, 2021

Study information

• Verified date: December 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The Combat Bladder Recirculation System (BRS) is a CE marked device which has been used in over 200 sites in Europe. It is an aluminum heat exchanger that allows hyperthermic intravesical chemotherapy (HIVEC) at 43±0.2 degrees for patients with bladder cancer. Previous studies showed that the Combat BRS could warm the entire bladder wall to the target temperature with excellent safety parameters. The flow rates and pressure levels are kept low during the HIVEC treatment. A previous study has demonstrated the safety and tolerability of HIVEC as a maintenance therapy for patients with non-muscle-invasive bladder cancer (NMIBC), and two randomized controlled trials are underway to demonstrate its efficacy in terms of disease recurrence and progression. On the other hand, the use of HIVEC immediately following transurethral resection of bladder tumour (TURBT) remains largely unexplored. It is the investigators' current practice to give intravesical mitomycin C (MMC) to all patients who have endoscopically NMIBC with complete resection, provided that there are no bladder perforations being noted. In this study, the investigators shall evaluate the safety and feasibility of hyperthermia in addition to the current practice of intravesical MMC alone immediately following TURBT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 7, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Chemotherapy Effect
• Fever
• Hyperthermia
• Urinary Bladder Neoplasms

Intervention

Other:
• Hyperthermic intravesical chemotherapy
Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (6)

Babjuk M, Böhle A, Burger M, Capoun O, Cohen D, Compérat EM, Hernández V, Kaasinen E, Palou J, Rouprêt 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. — View Citation

Kok 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. Review. — View Citation

Owusu 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. Review. — View Citation

Schooneveldt 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. Review. — View Citation

Sylvester 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. Epub 2006 Jan 17. — View Citation

Teicher 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day complications	Complications which occur within 30 days after the experimental treatment	Thirty days after the experimental treatment
Secondary	Hyperthermic intravesical chemotherapy instillation rate	Rate of hyperthermic intravesical chemotherapy instillation given after the operation	One day after surgery
Secondary	Duration of urethral catheterisation	Duration of urethral catheterisation after the experimental treatment	Two days after the experimental treatment
Secondary	Rate of bladder irrigation	Rate of bladder irrigation given after the experimental treatment	One day after the experimental treatment
Secondary	Duration of bladder irrigation	Duration of bladder irrigation after the experimental treatment	Two days after the experimental treatment
Secondary	Hospital stay	Duration of hospital stay for the experimental treatment	Three days after the experimental treatment