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

December 30, 2021 updated by: Jeremy Yuen Chun TEOH, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperthermic intravesical chemotherapy
Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour
Other: Hyperthermic intravesical chemotherapy
Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day complications
Time Frame: Thirty days after the experimental treatment
Complications which occur within 30 days after the experimental treatment
Thirty days after the experimental treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperthermic intravesical chemotherapy instillation rate
Time Frame: One day after surgery
Rate of hyperthermic intravesical chemotherapy instillation given after the operation
One day after surgery
Duration of urethral catheterisation
Time Frame: Two days after the experimental treatment
Duration of urethral catheterisation after the experimental treatment
Two days after the experimental treatment
Rate of bladder irrigation
Time Frame: One day after the experimental treatment
Rate of bladder irrigation given after the experimental treatment
One day after the experimental treatment
Duration of bladder irrigation
Time Frame: Two days after the experimental treatment
Duration of bladder irrigation after the experimental treatment
Two days after the experimental treatment
Hospital stay
Time Frame: Three days after the experimental treatment
Duration of hospital stay for the experimental treatment
Three days after the experimental treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

December 7, 2021

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE Ref. No. 2018.206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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