A randomized competitive trial of BCG instillation therapy with UFT for prevention of superficial bladder cancer recurrence.

UMIN ID: UMIN000001861

Registered date:01/05/2009

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Bladder cancer
• Date of first enrollment: 2009/05/01
• Target sample size: 354
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Bladder instillation therapy of BCG.
Bladder instillation therapy of BCG. + UFT (400mg/day as tegefur)

Outcome(s)

• Primary Outcome: Duration of recurrence free survival within 3 years.
• Secondary Outcome: Safety QOL investigation

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) TNM classification; Ta&G1, Ta&G2, T1&G1,initial, single, primary CIS. 2) Prior therapy of BCG and/or UFT. 3) Prior therapy of irradiation. 4) Presence of active other cancers. 5) Having a severe complications occurred within 3 months before this study; serious heart disease, severe hypertension, severe diabetes, severe angina, ileus, interstitial-Pneumonitis, lung fibrosis, heart failure, renal failure, liver dysfunction, severe infection. 6) HIV patient, need of steroid therapy. 7) Strong positivity for tuberculin test. 8) Presence of water severe diarrhea. 9) Contraindications for BCG or UFT.(According to attached files of BCG or UFT.) 10) Presence of severe allergy for medicines. 11) A pregnant women, a woman of breast-feeding, a woman who want to get pregnant. 12) A man who want to make pregnant.

Related Information

• Primary Sponsor: Study Group of Urothelial Cancer Kitasato institute hospital Kitasato University Kyorin University Keio University Showa University Teikyo University Tokyo Medical University Jikei University Toho University
• Source(s) of Monetary Support: None