Transitional Cell Carcinoma Clinical Trial
Official title:
Intravesically Heated Thermo-chemotherapy With Mitomycin-C Prior to TURBT- Prospective Controlled Study
Transurethral Resection of Bladder Tumor (TURBT) is the initial treatment procedure for
urinary bladder cancer. Recurrence rate during the first year ranges between 15-38% in case
of low-intermediate disease. Current literature advocate using intravesical instillations of
Mitomycin-C (MMC) immediately post TURBT in order to reduce the rate of recurrence.
During the last decade, heated intravesical instillations have emerged as additional
players, in the treatment of recurrent disease. By most cases, the heated intravesical
instillations are given either by microwave hyperthermia (synergo®) or by conductive heat
bladder wall thermo-chemotherapy (BWT).
Previous reports suggest up to 59% reduction rate in recurrence following
thermo-chemotherapy upon recurrent disease. These outstanding reduction results haven't
convinced significant amount of urologists worldwide to use the intravesical instillation
close after endoscopic resection as TURBT, probably due to the fear of MMC adverse effects
in an operated area or the fear of complications due to perforated bladder. Preliminary
results have suggested favourable outcome when MMC is used prior to TURBT [see publication].
To the investigators' knowledge no previous study has prospectively examined the effect of
preliminary heated intravesical installation with BWT.
Scientific hypothesis: Patients treated with preliminary intravesical installation in a
timely fashion before TURBT are expected to show lower recurrence rate and better outcome
then control patients.
Participants: Three hundred patients designed to undergo TURBT in the urology department at
"Sheba" Medical Center at "Tel Hashomer", Israel.
Exiting the research:
1. Patient is not completing the procedure due to allergic reaction or serious adverse
effect during the heated intravesical instillation .
2. Patient having according to pathology report muscle invasive bladder cancer (MIBC) and
expects to undergo cystectomy.
Protocol steps Eligible patients give their consent to participate in the study. A
preliminary grouping (for low, intermediate and high risk groups) will be initiated
according to cystoscopy examination results. (this step is for administrative purpose in
order to achieve equal amount of participants between groups during follow-up phase) Then
participants will randomly assign, according to randomized computer software to two major
arms, those who receive the heated thermo-chemo therapy and those who will not. The
intravesical instillation will take place up to 6 hours prior TURBT in the following matter:
The "Elmedical" system will introduce intravesically a 40mg of heated Mitomycin-C (MMC),
diluted in 50cc of saline at a uniform temperature (44-44.50C). The length of the procedure
- 50 minutes.
Once pathological reports will arrive, the participant will assign to his/her actual risk
group stratification. Participants with recurrent disease will be assigned into separated
intermediate or high risk groups accordingly.
consequently five stratification groups are created in each major research arm (with or
without prior heated intravesical instillation) Follow-up of each participant, at any group
takes two years. During the follow-up period a urine cytology and routine cystoscopy will be
carried out every 3 month. Patients with intermediate to high risk disease will receive six
courses of intravesical bacillus Calmette-Guerin (BCG) installation according to
international guidelines. Participants who for any reason won't be able to complete the BCG
intravesical instillations will be offered a MMC instillation instead. Participant that
pathological report is indicating a muscle invasive disease will be offered a cystectomy and
exit the study (unless the participant avoids cystectomy by his/her own decision).
The investigators are obligate ourselves for surveillance according to international
guidelines (as intravesical instillations of BCG or performing repeat TURBT / Biopsy by
need).
Potential bias: Different surgical skills between urologists, Quality of pre-TURBT
installation of thermo-chemotherapy.
Duration: Four years with two years follow up per participant.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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