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
    Recruiting
  • participants needed
    288
  • sponsor
    Urological Oncology Council of Northern Tokyo
Updated on 8 November 2020
cancer
bladder cancer
transurethral resection
bladder tumor
transurethral bladder excision
superficial bladder cancer
intravesical administration

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.

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.

Details
Condition bladder cancer
Treatment Bacille Calmette-Guérin, uracil-tegafur
Clinical Study IdentifierNCT01082510
SponsorUrological Oncology Council of Northern Tokyo
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 80 yrs?
Gender: Male or Female
Do you have bladder cancer?
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
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