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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2009
INTERVENTION: Bladder instillation therapy of BCG. Bladder instillation therapy of BCG. + UFT (400mg/day as tegefur) CONDITION: Bladder cancer PRIMARY OUTCOME: Duration of recurrence free survival within 3 years. SECONDARY OUTCOME: Safety; QOL investigation 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.
Epistemonikos ID: e85de53bbd4d00d415f4f96602cfebac5eaecfaf
First added on: Aug 22, 2024