Clinical trial • Phase IV • Oncology
MITOMYCIN for Non-muscle invasive bladder cancer | Non-muscle invasive urothelial carcinoma
Phase IV trial of MITOMYCIN for Non-muscle invasive bladder cancer | Non-muscle invasive urothelial carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-muscle invasive bladder cancer | Non-muscle invasive urothelial carcinoma
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 15-10-2024
- First CTIS Authorization Date
- 25-10-2024
Trial design
Randomised, mitomycin c (mmc) intravesical: preoperative mmc administered by electromotive drug administration (emda) versus postoperative passive diffusion mmc instillation after transurethral resection (tur). product information lists a maximum total dose amount of 40 mg (doseuom: mg).-controlled Phase IV trial across 2 sites in Spain.
- Randomised
- Yes
- Comparator
- Mitomycin C (MMC) intravesical: preoperative MMC administered by electromotive drug administration (EMDA) versus postoperative passive diffusion MMC instillation after transurethral resection (TUR). Product information lists a maximum total dose amount of 40 mg (doseUom: mg).
- Target Sample Size
- 228
- Trial Duration For Participant
- 1826
Eligibility
Recruits 228 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must provide documented and signed informed consent (inclusion criterion: "Documented and signed authorization to participate in clinica trial"). A Subject Information and Informed Consent Form document is listed for publication; translations of trial titles are available in Spanish, suggesting consent materials are available at least in Spanish. No assent or specific minor/guardian consent procedures are described..
- Pregnancy Exclusion
- Pregnancy.
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must provide documented and signed informed consent (inclusion criterion: "Documented and signed authorization to participate in clinica trial"). A Subject Information and Informed Consent Form document is listed for publication; translations of trial titles are available in Spanish, suggesting consent materials are available at least in Spanish. No assent or specific minor/guardian consent procedures are described.
Inclusion criteria
- {"criterion_text":"- Patients with suspected urothelial cell carcinoma Ta or T1 based on cystoscopy and/or ultrasound.\n- Primary papillary tumor\n- Recurrent low-grade single or multiple tumors.\n- Patients with preserved renal function (serum creatinine < 1.12 mg/dl) and normal liver function (gamma-glutamyl transpeptidase ≤ 51 U/L, alanine aminotransferase ≤ 50 U/L, and total bilirubin ≤ 22 μmol/L).\n- Documented and signed authorization to participate in clinica trial"}
Exclusion criteria
- {"criterion_text":"- Patients with histology different from urothelial carcinoma after the pathological analysis of the surgical specimen.\n- History of untreated urinary tract infection.\n- Severe systemic infection.\n- Treatment with radiotherapy or chemotherapy.\n- Treatment with immunosuppressants.\n- Patients with a pacemaker or implantable cardioverter-defibrillator (ICD).\n- Other malignancies within the 5 years prior to study inclusion (except for effectively treated skin cancer or localized cervical cancer).\n- Pregnancy.\n- Patients with bladder cancer staged ≥ T2.\n- Patients with synchronous upper tract urothelial carcinoma (UTUC)\n- Allergy to Mitomycin-C.\n- Patients who, in the investigator's opinion, are unable to complete the study questionnaires or attend follow-up visits.\n- Patients with recurrent high-grade tumor.\n- Patients with recurrent CIS.\n- Reduced bladder capacity (less than 200 cc)\n- History of high-grade bladder tumor or CIS."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Recurrence free survival\n- Progresion free survival","definition_or_measurement_approach":"Recurrence free survival: recurrence is defined as the appearance of a new non-muscle invasive bladder tumor with staging/grade equal to or lower than the baseline tumor; time to first event measured from randomisation to recurrence. Progresion (Progression) free survival: progression is defined as the appearance of a new bladder tumor with staging/grade higher than the baseline tumor; time to first event measured from randomisation to progression."}
Secondary endpoints
- {"endpoint_text":"- Total cases of adverse effects by group\n- Therapeutic completion rate by group\n- Impact of recurrence free survival and progresion free survival depending on inflammatory response parameters","definition_or_measurement_approach":"Total cases of adverse effects by group: count and compare adverse events reported in each randomized arm. Therapeutic completion rate by group: percentage of patients in each group who complete the full assigned treatment (preoperative EMDA+MMC or postoperative passive diffusion MMC). Impact on inflammatory parameters: analysis of effect of inflammatory markers (neutrophil/lymphocyte ratio and platelet/lymphocyte ratio) on recurrence-free and progression-free survival."}
Recruitment
- Planned Sample Size
- 228
- Recruitment Window Months
- 60
- Consent Approach
- Participation requires documented and signed informed consent (inclusion criterion). A Subject Information and Informed Consent Form document is listed for publication (L1_SIS and ICF_general_version1_1). Trial titles and summaries have Spanish translations, indicating consent/information materials are available in Spanish; no age-specific assent/guardian consent procedures are described.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 228
Spain
- Latest Decision Or Authorization Date
- 25-10-2024
- Number Of Sites
- 2
- Number Of Participants
- 228
Sites
- Site Name
- Hospital General Universitario De Castellon
- Department Name
- Urology
- Principal Investigator Name
- Miguel Rodrigo Aliaga
- Principal Investigator Email
- rodrigo_migali@gva.es
- Contact Person Name
- Miguel Rodrigo Aliaga
- Contact Person Email
- rodrigo_migali@gva.es
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Urology
- Principal Investigator Name
- Jose Luis Dominguez Escrig
- Principal Investigator Email
- jldominguez@fivo.org
- Contact Person Name
- Jose Luis Dominguez Escrig
- Contact Person Email
- jldominguez@fivo.org
Sponsor
Primary sponsor
- Full Name
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- MITOMYCIN
- Active Substance
- MITOMYCIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVESICAL USE
- Route
- INTRAVESICAL USE
- Maximum Dose
- 40 mg
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