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)

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01082510
• Other study ID #: EMBARK
• Status: Recruiting
• Phase: Phase 3
• First received: March 5, 2010
• Last updated: March 22, 2011
• Start date: January 2010
• Est. completion date: December 2019

Study information

• Verified date: October 2010
• Source: Urological Oncology Council of Northern Tokyo
• Contact: Satoru Muto, PhD
• Phone: +81 3 3964 2497
• Email: muto[@]med.teikyo-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Department of Urology, Teikyo University Hospital	Itabashi-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Urological Oncology Council of Northern Tokyo

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival rate		Three-year	No