Abstract
Background: To confirm the treatment effects of concurrent cetuximab plus docetaxel observed in Radiation Therapy Oncology Group (RTOG) 0234 and single out the effect of cetuximab, we designed RTOG 1216, a randomized phase II/III study, which uses an intermediate end point to select the best regimen for definitive testing of survival benefit. Methods: In phase II, the best regimen should demonstrate statistically significant efficacy against the control with predefined advantage over the competing arm regarding disease-free survival (DFS). We evaluate operating characteristics of the randomized II/III group sequential design through simulations and numerical integrations under the null and various alternative hypotheses. Results: Results show the randomized II/III design yields substantial savings on sample size and time with well-controlled type I and type II error rates. Conclusion: Overall, the proposed randomized II/III design has desirable properties that offer cost effectiveness, operational efficiency, and, most importantly, scientific innovation that can be considered for similar clinical research settings.
Original language | English (US) |
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Pages (from-to) | 37-45 |
Number of pages | 9 |
Journal | Head and Neck |
Volume | 41 |
Issue number | 1 |
DOIs | |
State | Published - Jan 2019 |
Keywords
- head and neck
- oncology
- randomized II/III design
- survival
- treatment selection
ASJC Scopus subject areas
- Otorhinolaryngology
MD Anderson CCSG core facilities
- Clinical Trials Office