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

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: Bladder Cancer
• Intervention / Treatment: Drug: Bacille Calmette-Guerin; Drug: uracil-tegafur

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

Study Locations

• Japan
  • Tokyo
    • Itabashi-ku, Tokyo, Japan
      • Recruiting
      • Department of Urology, Teikyo University Hospital
      • Contact: Shigeo Horie, PhD; Phone Number: +81 3 3964 2497; Email: shorie@med.teikyo-u.ac.jp

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Three-year

Collaborators and Investigators

• Sponsor: Urological Oncology Council of Northern Tokyo

Study record dates

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: BCG; UFT
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Disease Attributes; Recurrence; Urinary Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tegafur
• Other Study ID Numbers: EMBARK