Clinical trial · Interventional
Sequential Intravesical Bacillus Calmette-Guérin and Electromotive Mitomycin-C After Transuretheral Resection
Adjuvant Sequential Intravesical BCG (Bacillus Calmette-Guérin) and Electromotive Mitomycin-C (EMDA/MMC) After Transuretheral Resection (TUR) in Patients With Primary High Risk Non-Muscle Invasive Transitional Cell Carcinoma of the Bladder
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The institution was requiring extensive changes to the protocol
Summary
Brief summary (as posted)
The primary objective of the study is to assess the bladder cancer recurrence free rate, according to a phase II pilot study, of intravesical instillation of sequential BCG and EMDA/MMC after TUR. The study is designed as a one-sample investigation: the outcome measure is disease recurrence rate. Follow up will continue up to 5 years. For sample size determination, disease recurrence rate will be compared with literature data of recurrence rate obtained in standard BCG alone administration (Lamm's protocol).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravesical BCG and EMDA/MMC | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravesical BCG and EMDA/MMC
- description
- Patients are assigned one course of treatment per week for 6 weeks of Intravesical Intravesical BCG and EMDA/MMC
- interventionNames
- Device: Intravesical BCG and EMDA/MMC
Primary outcomes (1)
- measure
- To Assess Disease Recurrence Rate
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- To Compare Complete Response Rates at 3 and 6 Months in Patients With Carcinoma in Situ.
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * After a restaging TURBT patients with histologically proven primary high grade (grade3) and/or pT1 transitional cell carcinoma of the bladder, with or without pTis and pTis alone are regarded as being at high risk for tumour recurrence and progression. * Patients may enroll in this study if they are thought to have no residual disease after TURBT. * Age 18 years or over * Adequate bone-marrow reserve- ECOG performance status between 0 and 2 * Patients who are known PPD positive will be screened for active tuberculosis prior to starting treatment with BCG. Exclusion Criteria: * known allergy to BCG or MMC * prior systemic infection with BCG * prior or concomitant urothelial tumours of the upper urinary tract or urethra * previous muscle-invasive (ie, stage T2 or higher) transitional-cell carcinoma of the bladder * bladder capacity of less than 200 ml * untreated urinary-tract infection * severe systemic infection (ie, sepsis) * known HIV-positivity; therapy with immunosuppressive agents * urethral strictures that would prevent endoscopic procedures and repeated catheterisation * upper urinary tract disease (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures a risk * previous radiotherapy to the pelvis * other concurrent chemotherapy * treatment with radiotherapy-response or biological-response modifiers * history of tuberculosis; * other malignant diseases within 5 years of trial registration (except for adequately treated basal-cell or squamous cell skin cancer, in situ cervical cancer and any other cancer from which patients has been disease-free for 3 years); * pregnancy or nursing * psychological, familial, sociological, or geographical factors that would preclude study participation. * Patients with implantable or wearable electrical devices will be excluded from this study. * Patients with active tuberculosis
References
Publications (0)
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