The incorporation of chemotherapy into a combined modality approach for treating newly diagnosed, advanced head and neck cancer has been under evaluation since the 1970s. In this review, the criteria for a well-designed prospective randomized trial are delineated based on prognostic factors determined from single-institution induction chemotherapy trials. The results of randomized controlled trials conducted from 1978 to the present are discussed with respect to their impact on survival, locoregional disease control, and the development of distant metastasis. Each study is then critiqued for its design, conduct, and interpretation. Organ preservation, improved locoregional control, and survival are important goals for future trials.
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