Study of the Efficacy of Maintenance Therapy by UFT or BCG for Superficial Bladder Cancer Against Recurrence in Urological Oncology Council of Northern Tokyo: EMBARK Study
Patients who have undergone transurethral resection of a superficial bladder tumor (TUR-Bt)
and BCG induction therapy are eligible for enrollment in this study. In principle, BCG
induction therapy consists of the successive weekly intravesical administration of 81 mg of
BCG-Connaught strain or 80 mg of BCG-Japan strain for 6 weeks after the completion of
The patients will be randomly assigned to a BCG maintenance therapy arm or a UFT maintenance
therapy arm. The patients in the BCG maintenance therapy arm will be treated with 3
successive weekly intravesical administrations of BCG at 3, 6, 12 and 18 months after the
start of BCG induction therapy. The dosage of BCG used for BCG maintenance therapy will be
the same as that used for BCG induction therapy. Patients in the UFT maintenance therapy arm
will be treated with the oral administration of 400 mg of UFT everyday for three years after
the end of BCG induction therapy.
The primary endpoint of this study is the three-year relapse-free survival rate.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Relapse-free survival rate
Japan: Institutional Review Board