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)
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.
Drug: Bacille Calmette-Guerin
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Relapse-free survival rate [ Time Frame: Three-year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
|Active Comparator: BCG maintenance therapy||
Drug: Bacille Calmette-Guerin
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 the BCG maintenance therapy will be the same as that used for BCG induction therapy.
|Experimental: UFT maintenance therapy||
The UFT maintenance therapy arm patients will be treated with the oral administration of 400 mg of UFT everyday for three years after the end of BCG induction therapy.
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 TUR-Bt.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082510
|Contact: Satoru Muto, PhD||+81 3 3964 firstname.lastname@example.org|
|Department of Urology, Teikyo University Hospital||Recruiting|
|Itabashi-ku, Tokyo, Japan|
|Contact: Shigeo Horie, PhD +81 3 3964 2497 email@example.com|