Bladder Cancer TNM Staging Primary Tumor (T) TaPhase 2/3EMDA/MMCNCT01920269
Intravesical Adjuvant Electromotive Mitomycin-C
A Phase 2/3 study testing Trans-urethral resection, intravesical passive diffusion mitomycin and intravesical electromotive mitomycin in people with Bladder Cancer TNM Staging Primary Tumor (T) Ta and Bladder Cancer TNM Staging Primary Tumor (T) T1, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
In laboratory and clinical studies, intravesical electromotive drug administration increased mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive urothelial bladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer TNM Staging Primary Tumor (T) Ta, Bladder Cancer TNM Staging Primary Tumor (T) T1, Bladder Cancer Transitional Cell Grade
- What is being tested?
- Trans-urethral resection, intravesical passive diffusion mitomycin and intravesical electromotive mitomycin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1994to Jun 2013
- Phase
- Phase 2/3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven primary stage pTa-pT1 urothelial bladder cancer,
- adequate bone-marrow reserve (ie, white-blood-cell count ≥4000 × 10⁶ cells per L; platelet count ≥120 × 10⁹/L),
- normal renal function (ie, serum creatinine ≤123·76 μmol/L),
- normal liver function (ie, serum glutamic-oxaloacetic aminotransferase ≤42 U/L, serum glutamic-pyruvic aminotransferase ≤48 U/L, and total bilirubin ≤22 μmol/L),
- Eastern Cooperative Oncology Group performance status between 0 and 2.
Who cannot join
- non-urothelial carcinomas of the bladder;
- previous or concomitant grade G3 urothelial and/or carcinoma in situ of the bladder;
- urothelial carcinoma of the upper urinary tract and urethra, or both;
- previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs;
- known allergy to mitomycin;
- bladder capacity less than 200 mL;
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- untreated urinary-tract
- infection; severe systemic infection (ie, sepsis);
- treatment with immunosuppressive drugs;
- urethral strictures that would prevent endoscopic procedures and catheterisation;
- previous radiotherapy to the pelvis;
- other concurrent chemo therapy, radio therapy, and treatment with biological response modifiers;
- other malignant diseases within 5 years of trial registration (except for adequately treated basal-cell or squamous-cell skin cancer, in situ cervical cancer);
- pregnancy;
- any factors that would preclude study participation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Tor Vergata University, Department of experimental Medicine and Surgery/Urology
Rome, RM, 00133
About this study
Official title: Intravesical Adjuvant Electromotive Mitomycin-C in Patients With pTa-pT1 and G1-G2 Non-muscle Invasive Bladder Cancer: a Randomized Controlled Trial
In laboratory and clinical studies, intravesical electromotive drug administration increased mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive urothelial bladder cancer. The investigators' aim was to compare transurethral resection of bladder tumor and adjuvant intravesical electromotive mitomycin with transurethral resection and adjuvant intravesical passive diffusion mitomycin and transurethral resection alone in patients with primary stage pTa-pT1 and grade G1-G2 urothelial bladder cancer Patients will be randomly assigned to: transurethral resection alone, transurethral resection and adjuvant intravesical 40 mg passive diffusion mitomycin dissolved in 50 ml sterile water infused over 60 minutes once a week for 6 weeks, or transurethral resection and adjuvant intravesical 40 mg electromotive mitomycin dissolved in 100 ml sterile water with 23 mA pulsed electric current for 30 minutes once a week for 6 weeks. Patients in the intravesical adjuvant electromotive and passive diffusion mitomycin groups who are disease-free 3 months after induction treatment, will be scheduled to receive monthly intravesical instillation for 10 months, with the same dose and methods of infusion as initial assigned treatment. All patients will be assessed for safety. The investigators' primary endpoints are recurrence rate and disease-free interval. Analyses will be done by intention to treat.
- Conditions
- Bladder Cancer TNM Staging Primary Tumor (T) Ta, Bladder Cancer TNM Staging Primary Tumor (T) T1, Bladder Cancer Transitional Cell Grade
- Being tested
- Trans-urethral resection, intravesical passive diffusion mitomycin, intravesical electromotive mitomycin
- Keywords
- non-muscle invasive bladder cancer, intravesical chemotherapy, mitomycin, passive diffusion, electromotive drug administration
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-urethral resectionProcedure or surgery
Patients underwent urinary cytology of the bladder and upper urinary tract; random cold-cup biopsies of the bladder and prostatic urethra, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples.
intravesical passive diffusion mitomycinDrug
Also called Mitomycin-C
A dose of 40 mg mitomycin dissolved in 50 ml sterile water is infused intravesically through a Foley catheter, retained in the bladder for 60 min with catheter clamping, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations, with the same dose and methods of infusion as initial assigned treatment.
intravesical electromotive mitomycinDevice
A dose of 40 mg mitomycin dissolved in 100 ml water is instilled and retained in the bladder for 30 minutes with 20 mA pulsed electric current, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations with the same dose and methods of infusion as initial assigned treatment. Intravesical electromotive drug administration is given by a battery-powered generator delivering a controlled electric current that passes between the active intravesical electrode (integrated into a specific transurethral catheter) and dispersive ground electrodes (on skin of the lower abdomen). Operators set active electrode polarity and current intensity on the generator.
| Study group | Role | What they receive |
|---|---|---|
| Transurethral resection alone | Active comparator | Patients underwent urinary cytology, random cold-cup biopsies of the bladder and prostatic urethra-ie, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples. Response to treatment will be assessed with cystoscopy, biopsy and urinary cytology at 3-month intervals for 2 years, 6-month intervals for 3 years and yearly thereafter. Receives: Procedure: Trans-urethral resection |
| Intravesical passive diffusion mitomycin | Active comparator | Patients underwent urinary cytology, random cold-cup biopsies of the bladder and prostatic urethra, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples. Patients are scheduled to receive an initial 6 intravesical mitomycin treatments at weekly intervals commencing 2 weeks after endoscopic procedures. Patients are placed on fluid restriction and oral sodium bicarbonate before intravesical mitomycin treatments. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations. Response to treatment will be assessed with cystoscopy, biopsy and urinary cytology at 3-month intervals for 2 years, 6-month intervals for 3 years and yearly thereafter. Receives: Procedure: Trans-urethral resection; Drug: intravesical passive diffusion mitomycin |
| Intravesical electromotive mitomycin | Active comparator | Patients underwent urinary cytology, random cold-cup biopsies of the bladder and prostatic urethra, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples. Patients are scheduled to receive an initial 6 intravesical mitomycin treatments at weekly intervals commencing 2 weeks after endoscopic procedures. Patients are placed on fluid restriction and oral sodium bicarbonate before intravesical mitomycin. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations. Response to treatment will be assessed with cystoscopy and urinary cytology at 3-month intervals for 2 years, 6-month intervals for 3 years and yearly thereafter. Receives: Procedure: Trans-urethral resection; Drug: intravesical passive diffusion mitomycin; Device: intravesical electromotive mitomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free interval
Time from randomisation to first cystoscopy noting recurrence as recorded by pathological assessment of transurethral-resection samples or biopsy samples
Measured: 120 months
Secondary outcomes (1)
Time to progression
time from randomisation until the onset of muscle invasive disease as recorded by pathological assessment of transurethral-resection samples or biopsy samples
Measured: 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJan 1994
- Primary completionDec 2004
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer TNM Staging Primary Tumor (T) TaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Collaborators
- University of L'Aquila, University Of Perugia
- Responsible party
- Principal investigator, Savino M. Di Stasi, University of Rome Tor Vergata
- Investigators
- Savino M Di Stasi, MD, PhD, Principal investigator, Tor Vergata University, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920269
- Sponsor's protocol ID
- UTV-72-1993
- Acronym
- EMDA/MMC
- Status last verified
- Aug 2013
- First submitted
- 7 Aug 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Adjuvant Electromotive Mitomycin-C in Patients With pTa-pT1 and G1-G2 Non-muscle Invasive Bladder Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01920269
- Acronym / sponsor ID
- EMDA/MMC / UTV-72-1993
- Conditions
- Bladder Cancer TNM Staging Primary Tumor (T) Ta, Bladder Cancer TNM Staging Primary Tumor (T) T1, Bladder Cancer Transitional Cell Grade
- Keywords
- non-muscle invasive bladder cancer, intravesical chemotherapy, mitomycin, passive diffusion, electromotive drug administration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Collaborators
- University of L'Aquila, University Of Perugia
- Study start
- Jan 1994
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Aug 2013 (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.
In laboratory and clinical studies, intravesical electromotive drug administration increased mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive urothelial bladder cancer. The investigators' aim was to compare transurethral resection of bladder tumor and adjuvant intravesical electromotive mitomycin with transurethral resection and adjuvant intravesical passive diffusion mitomycin and transurethral resection alone in patients with primary stage pTa-pT1 and grade G1-G2 urothelial bladder cancer Patients will be randomly assigned to: transurethral resection alone, transurethral resection and adjuvant intravesical 40 mg passive diffusion mitomycin dissolved in 50 ml sterile water infused over 60 minutes once a week for 6 weeks, or transurethral resection and adjuvant intravesical 40 mg electromotive mitomycin dissolved in 100 ml sterile water with 23 mA pulsed electric current for 30 minutes once a week for 6 weeks. Patients in the intravesical adjuvant electromotive and passive diffusion mitomycin groups who are disease-free 3 months after induction treatment, will be scheduled to receive monthly intravesical instillation for 10 months, with the same dose and methods of infusion as initial assigned treatment. All patients will be assessed for safety. The investigators' primary endpoints are recurrence rate and disease-free interval. Analyses will be done by intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transurethral resection alone | Active comparator | Procedure: Trans-urethral resectionPatients underwent urinary cytology, random cold-cup biopsies of the bladder and prostatic urethra-ie, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples. Response to treatment will be assessed with cystoscopy, biopsy and urinary cytology at 3-month intervals for 2 years, 6-month intervals for 3 years and yearly thereafter. |
| Intravesical passive diffusion mitomycin | Active comparator | Procedure: Trans-urethral resection, Drug: intravesical passive diffusion mitomycinPatients underwent urinary cytology, random cold-cup biopsies of the bladder and prostatic urethra, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples. Patients are scheduled to receive an initial 6 intravesical mitomycin treatments at weekly intervals commencing 2 weeks after endoscopic procedures. Patients are placed on fluid restriction and oral sodium bicarbonate before intravesical mitomycin treatments. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations. Response to treatment will be assessed with cystoscopy, biopsy and urinary cytology at 3-month intervals for 2 years, 6-month intervals for 3 years and yearly thereafter. |
| Intravesical electromotive mitomycin | Active comparator | Procedure: Trans-urethral resection, Drug: intravesical passive diffusion mitomycin, Device: intravesical electromotive mitomycinPatients underwent urinary cytology, random cold-cup biopsies of the bladder and prostatic urethra, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples. Patients are scheduled to receive an initial 6 intravesical mitomycin treatments at weekly intervals commencing 2 weeks after endoscopic procedures. Patients are placed on fluid restriction and oral sodium bicarbonate before intravesical mitomycin. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations. Response to treatment will be assessed with cystoscopy and urinary cytology at 3-month intervals for 2 years, 6-month intervals for 3 years and yearly thereafter. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically proven primary stage pTa-pT1 urothelial bladder cancer,
- adequate bone-marrow reserve (ie, white-blood-cell count ≥4000 × 10⁶ cells per L; platelet count ≥120 × 10⁹/L),
- normal renal function (ie, serum creatinine ≤123·76 μmol/L),
- normal liver function (ie, serum glutamic-oxaloacetic aminotransferase ≤42 U/L, serum glutamic-pyruvic aminotransferase ≤48 U/L, and total bilirubin ≤22 μmol/L),
- Eastern Cooperative Oncology Group performance status between 0 and 2.
Key exclusion criteria (15 listed)
- non-urothelial carcinomas of the bladder;
- previous or concomitant grade G3 urothelial and/or carcinoma in situ of the bladder;
- urothelial carcinoma of the upper urinary tract and urethra, or both;
- previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs;
- known allergy to mitomycin;
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 |
|---|---|---|
| Trans-urethral resectionPatients underwent urinary cytology of the bladder and upper urinary tract; random cold-cup biopsies of the bladder and prostatic urethra, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples. | Procedure or surgery | Intravesical electromotive mitomycin, Intravesical passive diffusion mitomycin, Transurethral resection alone |
| intravesical passive diffusion mitomycinAlso: Mitomycin-CA dose of 40 mg mitomycin dissolved in 50 ml sterile water is infused intravesically through a Foley catheter, retained in the bladder for 60 min with catheter clamping, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations, with the same dose and methods of infusion as initial assigned treatment. | Drug | Intravesical electromotive mitomycin, Intravesical passive diffusion mitomycin |
| intravesical electromotive mitomycinA dose of 40 mg mitomycin dissolved in 100 ml water is instilled and retained in the bladder for 30 minutes with 20 mA pulsed electric current, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations with the same dose and methods of infusion as initial assigned treatment. Intravesical electromotive drug administration is given by a battery-powered generator delivering a controlled electric current that passes between the active intravesical electrode (integrated into a specific transurethral catheter) and dispersive ground electrodes (on skin of the lower abdomen). Operators set active electrode polarity and current intensity on the generator. | Device | Intravesical electromotive mitomycin |
Primary outcome
Disease-free interval
Time frame: 120 months
Time from randomisation to first cystoscopy noting recurrence as recorded by pathological assessment of transurethral-resection samples or biopsy samples
1 secondary outcome
Time to progression
Time frame: 120 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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.
Savino M Di Stasi, MD, PhD principal investigator
Tor Vergata University, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trans-urethral resection, intravesical passive diffusion mitomycin and intravesical electromotive mitomycin in people with Bladder Cancer TNM Staging Primary Tumor (T) Ta and Bladder Cancer TNM Staging Primary Tumor (T) T1, run by University of Rome Tor Vergata at 1 site in Italy.
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 5 inclusion and 15 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: finished, as of the sponsor's last update on 9 Aug 2013. 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 Italy. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free interval (time frame: 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2013; AzTrials last refreshed its copy on 28 Oct 2026.