Intravesically Heated Thermo-chemotherapy With Mitomycin-C Prior to TURBT
1 other identifier
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedApril 28, 2016
April 1, 2016
2 years
May 27, 2015
April 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence rate of Urothelial carcinoma (UC) of bladder
Reduced recurrence rate of Urothelial carcinoma (UC) of bladder among patients receiving intravesical heated installations
Two years
Study Arms (2)
TURBT ONLY
NO INTERVENTIONA 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
BWT with Mitomycin-C prior TURBT
EXPERIMENTALA 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Adult patients (\>18 yrs.) with good performance status according to Eastern Cooperative Oncology Group (ECOG) scale, designed to TURBT and gave their consent to participate in our research.
- All participants must have adequate blood tests (CBC, Creatinine, electrolytes and liver function tests).
You may not qualify if:
- Concurrent other malignancy in the urinary system (e.g. upper tract UC)
- Urothelial malignancy of the bladder other then carcinoma
- Diffuse carcinoma in situ on preliminary cystoscopy
- Allergy or sensitivity to MMC
- Known urinary bladder capacity of less then 200cc
- Concurrent complicated urinary infection
- Autoimmune disease or patient under immunosuppressive therapy
- presence of urethral stricture
- Previous pelvic radiotherapy
- Concomitant malignancy of other organ
- Pregnancy
- Children under 18 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, Israel
Related Publications (1)
Di Stasi SM, Valenti M, Verri C, Liberati E, Giurioli A, Leprini G, Masedu F, Ricci AR, Micali F, Vespasiani G. Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial. Lancet Oncol. 2011 Sep;12(9):871-9. doi: 10.1016/S1470-2045(11)70190-5. Epub 2011 Aug 8.
PMID: 21831711BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Ramon, Prof.
Sheba Medical Center, Department od Urology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Urology department
Study Record Dates
First Submitted
May 27, 2015
First Posted
June 15, 2015
Study Start
January 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2019
Last Updated
April 28, 2016
Record last verified: 2016-04