Study to evaluate the efficacy and safety of supportive mitomycin C administered via electric current in the treatment of non-muscle invasive bladder cancer versus the standard immunotherapy.
Key facts
- Where
- A Coruña, Barakaldo, Barcelona, Cadiz, Coslada, Donostia, Logroño, Madrid, Murcia, Oviedo, Pamplona, San Cristóbal de La Laguna, Santander, Valencia, Valladolid és Vitoria, SpanyolországSee the 20 sites
- Phase
- 4. fázis
Where in Spanyolország
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpanyolországTaking people
- Hospital Universitario de CrucesBarakaldo, SpanyolországTaking people
- Fundació PuigvertBarcelona, SpanyolországTaking people
- Hospital Universitario Puerta del MarCadiz, SpanyolországTaking people
- Hospital Universitario Del HenaresCoslada, SpanyolországTaking people
- Hospital Universitario DonostiaDonostia, SpanyolországTaking people
- Hospital San PedroLogroño, SpanyolországTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- Hospital Universitario Ramón y CajalMadrid, SpanyolországTaking people
- Hospital General Universitario Morales MeseguerMurcia, SpanyolországTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpanyolországTaking people
- Hospital Universitario Central De AsturiasOviedo, SpanyolországTaking people
- Hospital Universitario de NavarraPamplona, SpanyolországTaking people
- Hospital Universitario de CanariasSan Cristóbal de La Laguna, SpanyolországTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpanyolországTaking people
- Fundación Instituto Valenciano de OncologíaValencia, SpanyolországTaking people
- Hospital 9 De Octubre S.A.Valencia, SpanyolországTaking people
- Hospital Universitario Rio HortegaValladolid, SpanyolországTaking people
- Hospital Universitario ArabaVitoria, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Presurgy S.L.
- Trial code
- EU 2024-520006-19-00
- Record updated
- 2025. október 9.
- Original description
To evaluate the efficacy of the adjuvant with EMDA-MMC (induction x6 weekly instillations and 1 year of maintenance) compared with the BCG standard (induction x6 weekly instillations and 1 year of maintenance) in the adjuvant treatment of High Grade NMLCC.Read full original descriptionShow less
Multicenter clinical trial with medical device associated with a drug in an authorised therapeutic use for the treatment of CVNMI evaluating the efficacy and tolerability of the adyuvant treatment with EMDA-MMC versus standard BCG in patients with high grade CVNMI
To evaluate the efficacy of the adjuvant with EMDA-MMC (induction x6 weekly instillations and 1 year of maintenance) compared with the BCG standard (induction x6 weekly instillations and 1 year of maintenance) in the adjuvant treatment of High Grade NMLCC.
Inclusion: Patients older than 18 years and life expectancy ≥ 5 years; Patients able to give informed consent for the study; Patients with primary non-muscle infiltrating urothelial non-muscle metamorphosed (NMIBC), uni- or multi-focal, stages Ta and T1, High Grade (2004 WHO), including old G2 High Grade and all G3; Patients treated with optically complete TUR of the tumor and, when indicated by clinical guidelines, RE-RTU that must be performed within the first 6 weeks; Negative bladder random biopsies for Tcis; Presence of own muscle in the TUR and / or in the RE-RTU; RE-RTU in all cases of T1 and also in Ta tumors when the initial TUR is incomplete or with absence of muscle in the sample.
Exclusion: Previous history of bladder tumors; Antecedents of pelvic radiotherapy (bladder, prostate, rectum, vagina, uterus); Patients with stage T1 who have not received RE-RTU; Relative contraindications for the use of the EMDA system - Urethral stricture. - Giant prostatic lobe with bladder neck occlusion. - Psychosis - Alcoholism - Active untreated urinary infection; Patients with a history of allergic reactions to BCG or MMC; Patients unable to give informed consent for their participation in the study; Stage tumors ≥T2; cN + and / or cM + tumors; Pregnant women; Patients with pacemakers or DICs; Absence of own muscle in the sample (neither in RTU nor in RE-RTU); Patients with Tcis isolated or associated with papillary tumor; Presence of squamous cell carcinoma of the bladder or bladder adenocarcinoma.