Transitional Cell CarcinomaNCT02471547
Intravesically Heated Thermo-chemotherapy With Mitomycin-C Prior to TURBT
A study testing BWT with Mitomycin-C prior TURBT in people with Transitional Cell Carcinoma, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Cell Carcinoma
- What is being tested?
- BWT with Mitomycin-C prior TURBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 12Show fewer
- Autoimmune disease or patient under immunosuppressive therapy
- presence of urethral stricture
- Previous pelvic radiotherapy
- Concomitant malignancy of other organ
- Pregnancy
- Children under 18 years.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Jacob Ramon, M.D, +9720526666280, jacob.ramon@sheba.health.gov.il
Assaf Bar El, M.D, +972544664774, assaf.barel@sheba.health.gov.il
About this study
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.
Read the detailed description
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:
- Patient is not completing the procedure due to allergic reaction or serious adverse effect during the heated intravesical instillation .
- 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.
- Conditions
- Transitional Cell Carcinoma
- Being tested
- BWT with Mitomycin-C prior TURBT
- Keywords
- Recurrence
- Medical subject headings
- Carcinoma, Transitional Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BWT with Mitomycin-C prior TURBTOther
Also called Bladder wall thermo-chemotherapy (BWT)
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
| Study group | Role | What they receive |
|---|---|---|
| TURBT ONLY | No intervention | 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 |
| BWT with Mitomycin-C prior TURBT | Experimental | 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 Receives: Other: BWT with Mitomycin-C prior TURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of Urothelial carcinoma (UC) of bladder
Reduced recurrence rate of Urothelial carcinoma (UC) of bladder among patients receiving intravesical heated installations
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transitional Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Jacob Ramon, Sheba Medical Center
- Investigators
- Jacob Ramon, Prof., Principal investigator, Sheba Medical Center, Department od Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471547
- Sponsor's protocol ID
- SHEBA-15-1760-JR-CTIL
- Status last verified
- Apr 2016
- First submitted
- 27 May 2015
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21831711
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesically Heated Thermo-chemotherapy With Mitomycin-C Prior to TURBT- Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT02471547
- Acronym / sponsor ID
- SHEBA-15-1760-JR-CTIL
- Conditions
- Transitional Cell Carcinoma
- Keywords
- Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Patient is not completing the procedure due to allergic reaction or serious adverse effect during the heated intravesical instillation .
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TURBT ONLY | No intervention | –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 |
| BWT with Mitomycin-C prior TURBT | Experimental | Other: BWT with Mitomycin-C prior TURBTA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BWT with Mitomycin-C prior TURBTAlso: Bladder wall thermo-chemotherapy (BWT)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 | Other | BWT with Mitomycin-C prior TURBT |
Primary outcome
Recurrence rate of Urothelial carcinoma (UC) of bladder
Time frame: Two years
Reduced recurrence rate of Urothelial carcinoma (UC) of bladder among patients receiving intravesical heated installations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Background: PubMed 21831711Di 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Ramon, Prof. principal investigator
Sheba Medical Center, Department od Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BWT with Mitomycin-C prior TURBT in people with Transitional Cell Carcinoma, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Ramon, Prof. (+972(0)526666280, jacob.Ramon@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of Urothelial carcinoma (UC) of bladder (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.