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