Adjuvant instillations in intermediate risk NMIBC: A Study comparIng Gemcitabine and MitomYciN (SIGYN-trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504945-30-00

Enrollment

340

Registered

2024-08-30

Start date

2021-03-16

Completion date

Unknown

Last updated

2024-08-30

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

Conditions

Primary or recurrent non-muscle invasive bladder cancer with intermediate risk of recurrence after transurethral tumour resection

Brief summary

Recurrence-free survival

Detailed description

Local toxicity and HRQol two weeks after last installation, Progression-free survival, Health economy, Adverse events

Interventions

DRUGMitomycin medac

DRUG40 mg

DRUGpulver och vätska till intravesikal lösning

DRUGGemcitabine Accord 100 mg/ml Koncentrat till infusionsvätska

DRUGlösning

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival	—

Secondary

Measure	Time frame
Local toxicity and HRQol two weeks after last installation, Progression-free survival, Health economy, Adverse events	—

Countries

Sweden

Outcome results

None listed

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