Last updated on February 2018

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)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: bladder cancer
  • Age: Between 20 - 80 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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