… 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 …

Purpose This randomized, controlled, multicenter, open-label, phase III study compared
docetaxel versus paclitaxel in patients with advanced breast cancer that had progressed after an …

… 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 …

… and cogently outlines attractions of the randomized phase II trial, as well as … randomized
phase II study designs, specifically examining phase II selection designs, randomized phase …

… 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 …

… Capecitabine remains the adjuvant standard of care after curatively resected BTC and the
control arm of future randomized studies. The BILCAP study was a randomized phase III study …

… In this article, we propose a Bayesian phase II/III treatment evaluation strategy. Patients are
randomized between E and S throughout. In phase 11, the decision of whether to stop early, …

… In contrast with previous studies that compared placebo with a titrated dosage of active
drug… 9 this phase III study was a true dosage-ranging study, enabling evaluation of benefit/risk …