FIG. 6:  This Figure shows the trial design of SWOG 8710.^[2]  This was a randomized trial of patients with muscle-invasive bladder cancer who received treatment with cystectomy alone or 3 cycles of neoadjuvant MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) plus cystectomy.  Patients were stratified by stage and age, to assure that the 2 study arms contained comparable types of patients.  The stage stratification was T2 versus T3-T4a.  It is important to recall that this study was performed almost 15 years ago, so T2 referred to what we now call T2a.  Age stratification was <65 years vs ≥65 years.  Patients were then randomized to one of the 2 study arms. 

The study was designed and powered for one-sided testing since there was sufficient experience with MVAC at the time to believe that it would not cause increased mortality in the study.  Furthermore, it was judged that the study would only affect standards of medical practice if neoadjuvant MVAC improved survival.