Bladder Cancer, Chemotherapy Effect, Hyperthermia
Conditions
Keywords
Hyperthermic intravesical chemotherapy, Bladder cancer
Brief 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.
Detailed 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.
Interventions
OTHERHyperthermic intravesical chemotherapy
Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective single-arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day complications | Thirty days after the experimental treatment | Complications which occur within 30 days after the experimental treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperthermic intravesical chemotherapy instillation rate | One day after surgery | Rate of hyperthermic intravesical chemotherapy instillation given after the operation |
| Duration of urethral catheterisation | Two days after the experimental treatment | Duration of urethral catheterisation after the experimental treatment |
| Rate of bladder irrigation | One day after the experimental treatment | Rate of bladder irrigation given after the experimental treatment |
| Duration of bladder irrigation | Two days after the experimental treatment | Duration of bladder irrigation after the experimental treatment |
| Hospital stay | Three days after the experimental treatment | Duration of hospital stay for the experimental treatment |
Countries
Hong Kong
Outcome results
None listed