drugset / Trial / NCT02254915

SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I

NCT02254915

RandomizedParallel-groupOpen-labelTreatment

Summary

A multi-institutional, prospective, randomised, open-label, superiority, comparative, active-controlled, phase 3 study. The study will compare Synergo RF-induced hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard treatment of bacillus Calmette-Guérin (BCG) therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC, and will evaluate recurrence and progression rate over two years of follow-up.

Timeline

Start
Primary completion
2020-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bacillus Calmette-Guérin Vaccine Other