Bladder cancer
Conditions
Interventions
Bladder instillation therapy of BCG.
Bladder instillation therapy of BCG. + UFT (400mg/day as tegefur)
Sponsors
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
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Bladder cancer 2)Pathological diagnosis ; transitional cell carcinoma. TNM classification ; Ta&G3, T1&G2, T1&G3, accompanying CIS, multifocal, cases with recurrence. *The cases of recurrence who did not receive BCG or UFT prior to this study can be included, regardless; number of tumors, Ta&G1, Ta&G2, T1&G1. 3)20 to 79 years old at diagnosis. 4)Performance status (ECOG) of the cases should be 0 or 1. 5)Function of important organ should be sufficient. 6)Tolerable for internal use for UFT. 7)Inspection value standard 3000/mm3 <= WBC < 12,000/mm3 Neutrophile ;1,500/mm3<= Platelet ;100,000/mm3<= sGOT/sGPT ; Within twice of normal range in respective institutes. sT-bilirubin; <1.5mg/dl Hb; =>9.0g/dls Creatinin; <1.5mg/dl 8) Agreement form for this study should be obtained from the patients.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of recurrence free survival within 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety QOL investigation | — |
Countries
Japan
Contacts
Public ContactJun Morita
Showa University Urology
Outcome results
None listed