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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

Tracking Information
First Submitted Date  ICMJE September 27, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date October 23, 2018
Actual Study Start Date  ICMJE October 22, 2018
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
30-day complications [ Time Frame: Thirty days after the experimental treatment ]
Complications which occur within 30 days after the experimental treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03689478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Hyperthermic intravesical chemotherapy instillation rate [ Time Frame: One day after surgery ]
    Rate of hyperthermic intravesical chemotherapy instillation given after the operation
  • Duration of urethral catheterisation [ Time Frame: Two days after the experimental treatment ]
    Duration of urethral catheterisation 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
  • Duration of bladder irrigation [ Time Frame: Two days after the experimental treatment ]
    Duration of bladder irrigation after the experimental treatment
  • Hospital stay [ Time Frame: Three days after the experimental treatment ]
    Duration of hospital stay for the experimental treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT
Official Title  ICMJE A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective single-arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • Hyperthermia
  • Chemotherapy Effect
Intervention  ICMJE Other: Hyperthermic intravesical chemotherapy
Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour
Study Arms  ICMJE Experimental: Hyperthermic intravesical chemotherapy
Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour
Intervention: Other: Hyperthermic intravesical chemotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689478
Other Study ID Numbers  ICMJE CRE Ref. No. 2018.206
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeremy Yuen Chun TEOH, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese University of Hong Kong
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP