Clinical trial design limitations in head and neck squamous cell carcinomas

PURPOSE OF REVIEW: The present article reviews the randomized trials contributing to the establishment of current standards for the treatment of head and neck cancer. It provides critical analysis of their methodology in order to facilitate future trial design. RECENT FINDINGS: From a prognosis perspective, head and neck cancers are a heterogeneous group of diseases. Following a number of randomized clinical trials evaluating the role of chemotherapy in the induction, concomitant and adjuvant settings, there has been considerable improvement in the treatment of locally advanced head and neck cancers during the last decade. It is, however, difficult to interpret and compare the results optimally and to build on efficient trial designs as most of the trials included patients with different levels of essential prognostic factors. SUMMARY: All key randomized trials will be reviewed according to eligibility criteria, subgroup issues, trial power and historical controls. Methodological interpretation and possible plans for the next generation of clinical trials will be presented.