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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by Urological Oncology Council of Northern Tokyo
Sponsor:
Information provided by:
Urological Oncology Council of Northern Tokyo
ClinicalTrials.gov Identifier:
NCT01082510
First received: March 5, 2010
Last updated: March 22, 2011
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: Bacille Calmette-Guerin
Drug: uracil-tegafur
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Urological Oncology Council of Northern Tokyo:

Primary Outcome Measures:
  • Relapse-free survival rate [ Time Frame: Three-year ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: January 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082510

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

Locations
Japan
Department of Urology, Teikyo University Hospital Recruiting
Itabashi-ku, Tokyo, Japan
Contact: Shigeo Horie, PhD    +81 3 3964 2497    shorie@med.teikyo-u.ac.jp   
Sponsors and Collaborators
Urological Oncology Council of Northern Tokyo
  More Information

No publications provided

Responsible Party: Shigeo Horie, Department of Urology, Teikyo University Hospital
ClinicalTrials.gov Identifier: NCT01082510     History of Changes
Other Study ID Numbers: EMBARK
Study First Received: March 5, 2010
Last Updated: March 22, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Urological Oncology Council of Northern Tokyo:
UFT
BCG

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Recurrence
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014