HIVEC-HEAT
Research type
Research Study
Full title
HIVEC® HEAT (Hyperthermic intravesical mitomycin mEdac) for pAtients with BCG-unresponsive nonmuscle-invasive bladder cancer Trial
IRAS ID
1007375
Contact name
Thomas Griffiths
Contact email
Sponsor organisation
University or Leicester
ISRCTN Number
ISRCTN49174478
Research summary
We aim to consent and recruit 238 participants in UK hospital urology departments, that have nonmuscle-invasive Bladder Cancer and have previously had BCG treatment (Bacillus Calmette-Guerin, a vaccine which is a type of immunotherapy medicine) but have not responded, the next treatment option is a cystectomy (removal of the bladder) and this trial is for those patients that are unsuitable or unwilling to undergo this procedure.
There are two depths of this high-grade cancer (papillary stage Ta or T1). High-grade cancer cells can also be flat patches in the bladder called Carcinoma in Situ (CIS). The trial is split into 2 sub studies:
Sub-Study 1: 123 participants will be required for CIS +/- completely resected papillary Ta/T1 disease that have not responded to having BCG treatment
Sub-Study 2: 115 participants for completely resected high-grade papillary Ta/T1 disease without CIS that have not responded to having BCG treatment.
Both study groups will be allocated the same trial treatment over a 1 year period- 15 treatments of mitomycin medac drug given via a catheter into the bladder, that will be gently warmed to 43°C using the HIVEC device, for 60 minutes. the treatment schedule will be once a week for the 1st 6 weeks and after the 12 week timepoint, treatment will be given monthly for 9 months (maintenance) treatment.
In Sub study 1 there will be mandatory biopsies for patients so that a retrospective analysis can be completed in an external lab.
All participants will be followed up for another year after treatment to have disease assessments to ensure they remain free of cancer and to check for any treatment related adverse events.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
24/WM/0148
Date of REC Opinion
4 Sep 2024
REC opinion
Further Information Favourable Opinion