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)

March 22, 2011 updated by: Urological Oncology Council of Northern Tokyo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Itabashi-ku, Tokyo, Japan
        • Recruiting
        • Department of Urology, Teikyo University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: BCG maintenance therapy
Drug: Bacille 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.
EXPERIMENTAL: UFT maintenance therapy
Drug: uracil-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse-free survival rate
Time Frame: Three-year
Three-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urological Oncology Council of Northern Tokyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

March 5, 2010

First Submitted That Met QC Criteria

March 5, 2010

First Posted (ESTIMATE)

March 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 22, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMBARK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe