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)

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Urological Oncology Council of Northern Tokyo
• Treatments: Tegafur

Criteria

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