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)

Urological Oncology Council of Northern Tokyo

Status and phase

Unknown

Phase 3

Conditions

Bladder Cancer

Treatments

Drug: uracil-tegafur

Drug: Bacille Calmette-Guerin

Study type

Interventional

Funder types

Other

Identifiers

NCT01082510

EMBARK

Details and patient eligibility

About

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.

Full description

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.

Enrollment

288 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Superficial bladder cancer
Completion of transurethral resection of bladder tumor (TUR-Bt)
Completion of BCG induction therapy after TUR-Bt. 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.
Age 20 to 80 years
ECOG performance status of 0 or 1
Bladder capacity ≥ 150 mL
Capable of oral UFT administration
Expected life prognosis ≥ 3 years
Hematopoietic WBC ≥ 3,000/mm^3
Neutrophil ≥ 1,500/mm^3
Platelet ≥ 100,000/mm^3
Hepatic AST and ALT ≤ 2 times upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL
Hemoglobin ≤ 9.0 g/dL
Creatinine ≤ 1.5 mg/dL

Exclusion criteria

Bladder cancer located in prostatic part of the urethra
Anamnesis of bladder cancer classified as cT2, cT3 or cT4
Anamnesis of metastatic bladder cancer
Anamnesis of upper urinary tract carcinoma in situ
Anamnestic treatment of intravesical BCG administration within previous 6 months
Prior anticancer chemotherapy or radiotherapy
Severe complication
Presence of contraindications for the administration of BCG or UFT
Pregnancy, lactation