Bulletin du cancer
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The aim of phase II clinical trials in oncology is to judge if a new treatment have a sufficient antitumor activity to justify further studies. They represent a crucial step in a new anticancer therapy development. The aim is to present phase II clinical trials planification and interpretation methods, end points, recent methods and news in tumor response assessment. ⋯ Recent tumor response evaluation theories ("Recist") are described. Phase II trials function in new treatment development is progressing : they could be sufficient, in some cases, to allow a temporary marketing authorization if a treatment show great efficacy. Global reflection upon new treatment and methods allowing marketing authorization is required.