Such trials are important, according to Marshall Posner, MD, Associate Professor of Medicine at Harvard Medical School and the Dana-Farber Cancer Institute in Boston, who is leading the Paradigm trial (ClinicalTrials.gov Identifier NCT00095875). There are sufficient data from randomized trials to support the use of docetaxel-cisplatin-5-fluorouracil-based induction chemotherapy as a reasonable treatment for patients with locally advanced head and neck cancer. There is also suggestive evidence that it might even be better than chemoradiotherapy alone. The question now is whether induction chemotherapy offers a significant advantage over chemoradiotherapy for organ preservation or survival, he said.
Enrollment in at least one of the trials is going slowly, though. Despite having been open for enrollment since August 2004, the Paradigm trial has accrued only about one-third of the planned patients.
Part of the cause for the slow enrollment, in Dr. Posner’s view, is that the trial is complex, with different radiation doses depending on the trial arm and an individual patient’s response to induction chemotherapy. The induction-plus-chemoradiation arm is so radically different from the chemoradiation arm that it is hard for patients to understand it. It is hard for physicians to explain, he said.