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Brief Title: 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)

INTRODUCTION

  • Org Study ID: CRE Ref. No. 2018.206
  • Secondary ID: N/A
  • NTC ID: NCT03689478
  • Sponsor: Chinese University of Hong Kong

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.


  • Overall Status
    Recruiting
  • Start Date
    October 22, 2018
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: 30-day complications

Primary Outcome 1 - Timeframe: Thirty days after the experimental treatment

CONDITION

  • Bladder Cancer
  • Hyperthermia
  • Chemotherapy Effect

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: +852 3505 2625

Email: jeremyteoh@surgery.cuhk.edu.hk

LOCATION

Facility Status Contact
Facility: Prince of Wales Hospital
Hong Kong,
Hong Kong
Status: Recruiting Contact:
Jeremy YC Teoh