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)

NCT01082510 | Unknown Phase 3

• 1 other identifier: EMBARK
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Keywords

UFT; BCG

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival rate

  Three-year

Study Arms (2)

BCG maintenance therapy

ACTIVE COMPARATOR

Drug: Bacille Calmette-Guerin

UFT maintenance therapy

EXPERIMENTAL

Drug: uracil-tegafur

Interventions

Bacille Calmette-Guerin DRUG

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.

BCG maintenance therapy

uracil-tegafur DRUG

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.

UFT maintenance therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Urological Oncology Council of Northern Tokyo: lead

Study Sites (1)

Department of Urology, Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Satoru Muto, PhD

CONTACT

+81 3 3964 2497; muto@med.teikyo-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: March 24, 2011

Record last verified: 2010-10

Locations

JP (1)