New concepts for phase I trials: evaluating new drugs combined with radiation therapy
Eric Deutsch*, Jean Charles Soria and Jean Pierre Armand
Correspondence *185 John Morgan Building, 3620 Hamilton Walk, Philadelphia, PA 19104, USA
Email eric.deutsch@wanadoo.fr
Some molecular targeted therapies can confer radiation response and minimize toxicity compared with chemoradiation regimens. Many of these molecular targeted drugs are being tested in clinical trials in combination with radiotherapy; however, for the optimal translation of these drugs in the clinical setting, their safety must be demonstrated in phase I clinical trials. The combination of new molecular targeted therapies and radiation might not necessarily be equivalent to the toxicity of the targeted drug plus the usual toxicity of radiation. Deutsch et al. discuss the need for specific and long-term clinical evaluation and the necessity to reassess phase I strategies, toxicity endpoints, and trial concepts in order to fully optimize these regimens.
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