The group sequential triangular test for phase II cancer clinical trials.

In cancer, phase II clinical trials are usually noncomparative. Their purpose is to determine whether a new chemotherapy is effective enough to warrant further evaluation in phase III. Therefore, in order to meet ethical requirements, decision-making methods must allow for early termination when inefficacy (or efficacy) is clear. We previously extended the Triangular Test, a group sequential method initially proposed for phase III trials, to phase II trials and demonstrated its advantages (i.e., type I error rate alpha and power close to the nominal values, reduction of the sample size) over other methods. The aim of this paper is to present the Triangular Test from a practical standpoint that will facilitate its application to phase II clinical trials in oncology. After summarizing the minimal theoretical knowledge required to use the method appropriately, we discuss its use in the design and analysis of a phase II cancer trial.