| Trial,Accrual years,Number of participants,pathologic primary tumor TNM staging,Treatment details,Control treatment details,Reason for trial stopping early,Median follow-up (yr),PMID | |
| Skinner [19],1980-1988,102,"pT3-pT4, pN+, M0",Cystectomy + 4 cycles of CAP:Cisplatin 100 mg/m2Cyclophosphamide 600 mg/m2Doxorubicin 60 mg/m2,Cystectomy,Benefit of treatment seen in trial,14.5,2284533 | |
| Bono [20],1984-1987,90 a,"pT2-pT4a, pN0, M0",Cystectomy + 4 cycles of:Cisplatin 70 mg/m2Methotrexate 40 mg/m2,Cystectomy,Did not stop early,3.4, | |
| Studer [21],1984-1989,91,"pT1 (grade 2)-pT4, pN1-2, M0",Cystectomy + 3 cycles of cisplatin 90 mg/m2,Cystectomy,Smaller difference than expected seen between treatments at interim analysis,6.4,8201695 | |
| "Stockle [23], Lehmann [24]",1987-1990,49,"pT3b-pT4a, pN+, M0",Cystectomy + 3 cycles of MVEC or MVAC:Cisplatin 70 mg/m2Methotrexate 30 mg/m2Vinblastine 3 mg/m2Adriamycin 30 mg/m2Epirubicin 45 mg/m2,Cystectomy,Benefit of treatment seen in trial at interim analysis,14.8,"7966789,16336326" | |
| Otto [25],1993-1999,108,"pT3, N1-2, M0",Cystectomy + 3 cycles of MVEC:Cisplatin 70 mg/m2Methotrexate 30 mg/m2Vinblastine 3 mg/m2Epirubicin 45 mg/m2,Cystectomy,Did not stop early,3.9, | |
| Stadler [3],1997-2006,114,"pT1-pT2, pN0, M0 (all p53+)",Cystectomy + 3 cycles of MVAC:Cisplatin 70 mg/m2Methotrexate 30 mg/m2Vinblastine 3 mg/m2Doxorubicin 30 mg/m2,Cystectomy,Smaller difference than expected seen between treatments at interim analysis,5.4,21810677 | |
| Freiha [22],1986-1993,51 b,"pT3b-pT4, any pN, M0",Cystectomy + 4 cycles of CMV:Cisplatin 100 mg/m2Methotrexate 30 mg/m2Vinblastine 4 mg/m2,Cystectomy + (same) chemotherapy on relapse,Smaller difference than expected seen between treatments,5.1,8558644 | |
| Cognetti [4],2001-2007,194,"pT2 (grade 3) pT3-pT4, pN0-2, M0",Cystectomy + 4 cycles of:Cisplatin 70 mg/m2Gemcitabine 1000 mg/m2Cisplatin given on day 2 or day 15,Cystectomy + (same) chemotherapy on relapse,Accrual slower than expected,4.5,21859900 | |
| Sternberg [5],2002-2014,284,"pT3-pT4 or pN1-3, M0","Cystectomy + choice of 4 cycles of either: (1) MVAC (28-d cycle), (2) high-dose MVAC (14-d cycle), or (3) GC:Cisplatin 70 mg/m2Methotrexate 30 mg/m2Vinblastine 3 mg/m2Adriamycin 30 mg/m2Gemcitabine 1000 mg/m2",Cystectomy + 6 cycles (same) chemotherapy on relapse,Accrual slower than expected,6.9,25498218 | |
| Zhegalik [6],2007-2013,100,"pT3-pT4 and/or pN+, M0",Cystectomy + 2 cycles of:Cisplatin 75 mg/m2Gemcitabine 1000 mg/m2,Cystectomy + (same) chemotherapy on relapse,Did not stop early,7.3,32395319 | |