Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

October 26, 2018

Primary Completion Date

November 1, 2025

Study Completion Date

November 1, 2025

Conditions
Bladder Cancer
Interventions
DRUG

BCG instillation therapy

Induction period of six weekly instillations of BCG followed by maintenance period of ten monthly instillations of BCG

DRUG

Sequential BCG and EMDA mitomycin C

"Induction period includes nine weekly instillations of sequential BCG and EMDA-MMC instillations applied as three cycles of BCG, BCG and EMDA-MMC. Induction period is followed by maintenance period of nine monthly instillations of sequential EMDA-MMC and BCG applied with three cycles of EMDA-MMC, EMDA-MMC and BCG.~BCG instillation is performed as a standard instillation.~Mitomycin C is administered with electromotive drug administration (EMDA) device (Instillation: 40 mg mitomycin C with 960 mg of excipient sodium chloride dissolved in 100 ml sterile water, EMDA settings: current rise rate 30-50 microamperes per second, max 25 milliamperes, treatment duration 30 min)"

Trial Locations (7)

15850

RECRUITING

Päijät-Häme Central hospital, Lahti

20521

RECRUITING

Turku University Hospital, Turku

33521

RECRUITING

Tampere University Hospital, Tampere

40620

RECRUITING

Jyväskylä Central Hospital, Jyväskylä

50100

RECRUITING

Mikkeli Central Hospital, Mikkeli

60220

RECRUITING

Seinäjoki Central Hospital, Seinäjoki

00029

RECRUITING

HYKS Peijas Hospital, Helsinki

All Listed Sponsors
collaborator

Finnbladder

OTHER

lead

Turku University Hospital

OTHER_GOV

NCT03664869 - Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer | Biotech Hunter | Biotech Hunter