Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT (I-HIVEC)

The Chinese University of Hong Kong

Status: Completed

Conditions: Chemotherapy Effect; Bladder Cancer; Hyperthermia

Treatments: Other: Hyperthermic intravesical chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03689478

CRE Ref. No. 2018.206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Hyperthermic intravesical chemotherapy

Experimental group

Description:

Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour

Treatment:

Other: Hyperthermic intravesical chemotherapy