An interventional study of BWT with Mitomycin-C prior TURBT in Transitional Cell Carcinoma, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-28.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
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:
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.
716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's planned enrollment of 300 is above the median of 49 across 549 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A total of 150 patients in this arm will be divided into five follow-up sub groups according to pathology reports. Group 1 - Primary Low risk patients Group 2 - Primary Intermediate risk patients Group 3 - Primary High risk patients Group 4 - Recurrent Intermediate risk patients Group 5 - Recurrent Intermediate risk patients
A total of 150 patients in this arm will be divided into five follow-up sub groups according to pathology reports. Group 1 - Primary Low risk patients Group 2 - Primary Intermediate risk patients Group 3 - Primary High risk patients Group 4 - Recurrent Intermediate risk patients Group 5 - Recurrent Intermediate risk patients
Other: BWT with Mitomycin-C prior TURBT
Participants will randomly assign, according to random computerized software, to 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" BWT system will introduce intravesically a 40mg of heated Mitomycin MMC, diluted in 50cc of saline at a uniform temperature (44-44.50C). The length of the procedure - 50 minutes
Also known as: Bladder wall thermo-chemotherapy (BWT)
Recurrence rate of Urothelial carcinoma (UC) of bladder
Reduced recurrence rate of Urothelial carcinoma (UC) of bladder among patients receiving intravesical heated installations
Time frame: Two years
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sheba Medical Center