Intravesical instillation therapy with bacillus Calmette-Guérin (BCG) and sequential BCG and electromotive mitomycin-C (EMDA-MMC) in patients with high-risk non-muscle-invasive bladder carcinoma (FINNBLADDER 10)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516320-33-00

Enrollment

300

Registered

2024-09-19

Start date

2019-01-07

Completion date

Unknown

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Brief summary

Recurrence: defined as occurrence of histologically confirmed urothelial cancer recurrence of any stage or grade. Time for recurrence will be calculated from randomization date to date of biopsy/TUR-BT confirming recurrence.

Detailed description

Progression: defined as occurrence of biopsy/TUR-BT confirmed urothelial cancer with higher T-category as follows: Time for progression is calculated from randomization to the date of biopsy/TUR-BT/radiological evidence of metastasis confirming progression

Interventions

DRUGBCG-medac

DRUGjauhe ja liuotin suspensiota varten

DRUGvirtsarakkoon

DRUGMitomycin medac

DRUG40 mg

DRUGjauhe ja liuotin liuosta varten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence: defined as occurrence of histologically confirmed urothelial cancer recurrence of any stage or grade. Time for recurrence will be calculated from randomization date to date of biopsy/TUR-BT confirming recurrence.	—

Secondary

Measure	Time frame
Progression: defined as occurrence of biopsy/TUR-BT confirmed urothelial cancer with higher T-category as follows: Time for progression is calculated from randomization to the date of biopsy/TUR-BT/radiological evidence of metastasis confirming progression	—

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026