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

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ClinicalTrials.gov Identifier: NCT03689478
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jeremy Yuen Chun TEOH, 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Hyperthermia Chemotherapy Effect Other: Hyperthermic intravesical chemotherapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective single-arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 30-day complications [ Time Frame: Thirty days after the experimental treatment ]
    Complications which occur within 30 days after the experimental treatment


Secondary Outcome Measures :
  1. Hyperthermic intravesical chemotherapy instillation rate [ Time Frame: One day after surgery ]
    Rate of hyperthermic intravesical chemotherapy instillation given after the operation

  2. Duration of urethral catheterisation [ Time Frame: Two days after the experimental treatment ]
    Duration of urethral catheterisation after the experimental treatment

  3. Rate of bladder irrigation [ Time Frame: One day after the experimental treatment ]
    Rate of bladder irrigation given after the experimental treatment

  4. Duration of bladder irrigation [ Time Frame: Two days after the experimental treatment ]
    Duration of bladder irrigation after the experimental treatment

  5. Hospital stay [ Time Frame: Three days after the experimental treatment ]
    Duration of hospital stay for the experimental treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689478


Contacts
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Contact: Jeremy YC Teoh, MBBS +852 3505 2625 jeremyteoh@surgery.cuhk.edu.hk
Contact: Jenny SY Yip, MPH +852 3505 1663 siuying@surgery.cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Jeremy YC Teoh         
Principal Investigator: Jeremy YC Teoh         
Sub-Investigator: Peter KF Chiu         
Sub-Investigator: Chi-Fai Ng         
Sub-Investigator: Chi-Hang Yee         
Sponsors and Collaborators
Chinese University of Hong Kong

Publications:

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Responsible Party: Jeremy Yuen Chun TEOH, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03689478     History of Changes
Other Study ID Numbers: CRE Ref. No. 2018.206
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Jeremy Yuen Chun TEOH, Chinese University of Hong Kong:
Hyperthermic intravesical chemotherapy
Bladder cancer

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Fever
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Body Temperature Changes
Signs and Symptoms