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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


Phase 3
20 Years
80 Years
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival rate

Outcome Time Frame:

Three-year

Safety Issue:

No

Authority:

Japan: Institutional Review Board

Study ID:

EMBARK

NCT ID:

NCT01082510

Start Date:

January 2010

Completion Date:

December 2019

Related Keywords:

  • Bladder Cancer
  • UFT
  • BCG
  • Urinary Bladder Neoplasms
  • Recurrence

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