… randomized phase II trial as the initial stage in a phase III protocol. The proposal was to
terminate the phase III study … rate to that of the control arm in the phase II stage. In this design, the …

… In this review of issues related to randomized phase II trial design, our … randomized
phase II study designs, specifically examining phase II selection designs, randomized phase II …

… This randomized phase III trial was designed to compare docetaxel and paclitaxel at … The
results of this study are consistent with those reported for previous phase III studies of single-…

… Based on the composite experience from these recent phase III studies, we suggest
strategies to aid future development and testing that may help bring this potentially powerful and …

… We conducted a randomized phase III study investigating the efficacy of S-1 as adjuvant
chemotherapy for colon cancer by evaluating its noninferiority to tegafur–uracil plus leucovorin (…

… , and phase II/III designs. The barriers to widespread adoption of randomized phase II trials
… We conclude that randomized phase II trials are a worthy investment considering finite …

… Study Design and Treatment The study was an open-label, randomized phase III study in …
The study was designed to compare the efficacy, safety, and tolerability of elacytarabine as a …

… In the 1990s, two small, randomized phase III trials, 20,21 mainly designed for patients
with stage III (N2) NSCLC, were terminated early on the basis of interim analyses showing …

Purpose The National Surgical Adjuvant Breast and Bowel Project C-08 trial was designed
to investigate the safety and effectiveness of adding bevacizumab to modified infusional …

… to single-agent DTIC chemotherapy in phase III clinical studies. The combination of chemotherapy
… , although a number of promising regimens are now being tested in phase III studies. …