Hyperthermia for Intermediate risk bladder cancer(HIVEC-II)
Research type
Research Study
Full title
A Phase II, Open Label, Multicenter Randomised Controlled Trial Comparing Hyperthermia Plus Mitomycin To Mitomycin Alone, In Patients with Intermediate Risk Non-Muscle Invasive Bladder Cancer.
IRAS ID
133367
Contact name
Paul Cathcart
Contact email
Sponsor organisation
Queen Mary University of London
Research summary
Bladder cancer is the fourth commonest non-dermatological malignancy in males, and tenth in women. Non-Muscle invasive bladder cancer (NMIBC) comprises 70-80% of cases and is defined as disease confined to the mucosa(Stage Ta) or lamina propria (T1), carcinoma in situ. Within three years 15-70% recur following Trans urethral resection (TUR).
Patients at intermediate risk for recurrence following TUR receive a single instillation of Mitomycin (MM) followed by an additional 6 instillations of MM. The MM is administered by passing a catheter into the bladder and instilling the chemotherapy for one hour. MM reduces the recurrence rate (Odds ratio 0.48 (95% CI 0.35 to 0.53)) and is the standard of care for intermediate risk NMIBC.
Hyperthermia in combination with chemotherapy has been used in cancer treatment. Hyperthermia adds to the effect of chemotherapy by increasing drug uptake, and enhancing cancer cell death. The Combat BRS system is used for the delivery of hyperthermic mitomycin (HM). MM is circulated in a closed system and warmed by an external heat exchanger at 43C. HM seems to be effective in bladder cancer but there is a lack of quality evidence and no randomised studies in patients with intermediate risk disease.
Patients with new or recurrent intermediate risk bladder cancer will be recruited to this trial and randomised between HM or Standard treatment (MM). Patients will receive HM or MM once weekly for 6 weeks and will be followed up for two years.
The aim of the trial is to determine whether HM is an effective therapy for patients with intermediate risk NMIBC. The study outcome will be disease free survival in patients with intermediate-risk NMIBC. Secondary outcomes will include, recurrence at 3 months and quality of life; translational samples will be collected for future research.REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1434
Date of REC Opinion
7 Nov 2013
REC opinion
Further Information Favourable Opinion