Study of the Efficacy of Maintenance Therapy Using Uracil-tegafur (UFT) or Bacille Calmette-Guerin (BCG) for the Prevention of Recurrences of Superficial Bladder Cancer (EMBARK Study)

Phase 3 Unknown 288 enrolled Urological Oncology Council of Northern Tokyo

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this prospective randomized controlled study is to prove the non-inferiority of UFT maintenance therapy to BCG maintenance therapy for preventing recurrences of superficial bladder cancer.

Timeline

Start: 2010-01
Primary completion: 2017-12
Completion: 2019-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bacille Calmette-Guerin	Vaccine	80 mg	Intravenous
Comparator	Bacille Calmette-Guerin	Vaccine	81 mg	Intravenous
Subject	uracil-tegafur	Unknown	400 mg	Oral

Study of the Efficacy of Maintenance Therapy Using Uracil-tegafur (UFT) or Bacille Calmette-Guerin (BCG) for the Prevention of Recurrences of Superficial Bladder Cancer (EMBARK Study)

Summary

Timeline

Drugs

Indications