Last Updated: 11/22/16
Sample Size Planning for an Integrated Phase II/III Study
The integrated phase II/III study design contains two portions. In the first portion of the study evidence of activity is gathered using progression free survival (PFS). If there is sufficient evidence of activity, accrual continues and enough patients are accrued until the phase III endpoint of overall survival can be assessed (patients from the first portion and the second portion are used in the final overall survival analysis) (Hunsberger, Zhao and Simon, Clin Cancer Res 2009).
This program calculates either simulated or an approximate expected time, expected sample size and final power for:
- the integrated phase II/III design
- a single randomized study with overall survival as the endpoint
- a single study with overall survival as the endpoint with a futility analysis based on survival
- separate randomized phase II followed by phase III