Clinical Trial Conundrums: More Art Than Science?

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In a recent study comparing proton therapy and intensity-modulated radiation therapy (IMRT), both of which spare surrounding tissues from excess radiation, patients with locally advanced lung cancer who received combination proton therapy and chemotherapy suffered less bone marrow toxicity and other side effects than those who received IMRT and chemotherapy. This phase II trial, conducted by Ritsuko Komaki, M.D., professor of radiation oncology at the University of Texas M. D. Anderson Cancer Center in Houston, lends credibility to the claim that proton therapy produces fewer side effects than radiation with photons because of its precision. The results, which were presented at the 2008 Chicago Multidisciplinary Symposium in Thoracic Oncology in November, also indicate a difference in survival between the two groups, which will be detailed in a forthcoming phase III randomized controlled trial (RCT), Komaki said. The new study is one of relatively few in which proton therapy is being tested, although proton therapy was introduced in the 1990s, before RCTs were performed.