Clinical trial · Interventional
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)
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
NCT01082510CI-TRIAL-00004601unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacille Calmette-Guerin | Drug | — | UNRESOLVED |
| uracil-tegafur | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- BCG maintenance therapy
- interventionNames
- Drug: Bacille Calmette-Guerin
- type
- EXPERIMENTAL
- label
- UFT maintenance therapy
- interventionNames
- Drug: uracil-tegafur
Primary outcomes (1)
- measure
- Relapse-free survival rate
- timeFrame
- Three-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.