The purpose of the HIVEC II trial is to find out if the combination of the new technology called hyperthermia (the use of heat) and a drug called mitomycin is more effective than mitomycin alone which is the standard treatment for bladder cancer in reducing the chances of bladder cancer returning.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. New or Recurrence of intermediate risk NMIBC following TURBT defined as;
✓. Age ≥ 18 yrs
✓. WHO performance status 0, 1, 2, 3
✓. Pre-treatment haematology and biochemistry values within acceptable limits:
✓. Negative pregnancy test for women of child-bearing potential.
✓. Available for long-term follow-up.
✓. Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
✓. Written informed consent.
Exclusion criteria
✕. Grade 3 TCC
✕. Carcinoma in situ.
✕. New solitary Ta G1 (small)
✕. New solitary Ta G2 (small)
✕. Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR.
✕. Bladder capacity \<200cc.
What they're measuring
1
To determine if HIVEC increases disease-free survival at 24 months compared to the comparator arm of MM alone.
Timeframe: After the last patient has completed 24 months follow-up