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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)

Primary Purpose

Bladder Cancer

Status

Unknown status

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Bacille Calmette-Guerin

uracil-tegafur

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring UFT, BCG

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Urology, Teikyo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BCG maintenance therapy

UFT maintenance therapy

Arm Description

Outcomes

Primary Outcome Measures

Relapse-free survival rate

Secondary Outcome Measures

Full Information

NCT ID

NCT01082510

First Posted

March 5, 2010

Last Updated

March 22, 2011

Sponsor

Urological Oncology Council of Northern Tokyo

1. Study Identification

Unique Protocol Identification Number

NCT01082510

Brief Title

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)

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Urological Oncology Council of Northern Tokyo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

UFT, BCG

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BCG maintenance therapy

Arm Type

Active Comparator

Arm Title

UFT maintenance therapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bacille Calmette-Guerin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

uracil-tegafur

Intervention Description

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.

Primary Outcome Measure Information:

Title

Relapse-free survival rate

Time Frame

Three-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Satoru Muto, PhD

Phone

+81 3 3964 2497

muto@med.teikyo-u.ac.jp

Facility Information:

Facility Name

Department of Urology, Teikyo University Hospital

City

Itabashi-ku

State/Province

Tokyo

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shigeo Horie, PhD

Phone

+81 3 3964 2497

shorie@med.teikyo-u.ac.jp

12. IPD Sharing Statement

Learn more about this trial

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)

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