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Status unknownNCT01082510Updated Mar 24, 2011

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)

A Phase 3 interventional study of Bacille Calmette-Guerin and uracil-tegafur in Bladder Cancer, sponsored by Urological Oncology Council of Northern Tokyo. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-03-24.

Sponsored by Urological Oncology Council of Northern Tokyo · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Bladder Cancer

Keywords

  • UFT
  • BCG
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 288 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

This is the only study on the registry with Urological Oncology Council of Northern Tokyo as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
288 participants (estimated)

Study arms

  • Active comparator
    BCG maintenance therapy

    Drug: Bacille Calmette-Guerin

  • Experimental
    UFT maintenance therapy

    Drug: uracil-tegafur

Interventions

  • DrugBacille Calmette-Guerin

    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 the BCG maintenance therapy will be the same as that used for BCG induction therapy.

  • Druguracil-tegafur

    The UFT maintenance therapy arm patients will be treated with the oral administration of 400 mg of UFT everyday for three years after the end of BCG induction therapy.

06

What researchers measure

Primary outcomes

  1. Relapse-free survival rate

    Time frame: Three-year

07

Study locations

1 of 1 sites recruiting
  • Department of Urology, Teikyo University Hospital
    Itabashi-ku, Tokyo, Japan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01082510
Lead sponsor
Urological Oncology Council of Northern Tokyo
First posted
Mar 8, 2010
Start date
Jan 2010
Primary completion
Dec 2017 (estimated)
Completion
Dec 2019 (estimated)
Last update
Mar 24, 2011

Study contacts

Satoru Muto, PhD
Contact
muto@med.teikyo-u.ac.jp
+81 3 3964 2497

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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