Comparison of power between randomized discontinuation design and upfront randomization design on progression-free survival.

ABSTRACT:

Purpose

Enrichment based on molecular characteristics has emerged as an important inclusion criterion in phase II trials of targeted anticancer agents. In this study, we evaluate a well-described method of population enrichment by tumor growth characteristics in the early development stage of targeted cytostatic agents.

Methods

For some solid tumors, such as pancreatic carcinoma, using a time-to-event end point (eg, time to disease progression) to evaluate the efficacy of a cytostatic agent in a phase II trial is more relevant than clinical response by Response Evaluation Criteria in Solid Tumors. In this setting, we compared the power of the randomized discontinuation and upfront randomization designs under two previously proposed tumor growth models for treatment effect wh

SUBMITTER: Fu P 

PROVIDER: S-EPMC2734425 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature