%0 Journal Article
%T Phase i study evaluating the treatment of patients with hepatocellular carcinoma (HCC) with carbon ion radiotherapy: The PROMETHEUS-01 trial
%A Stephanie E Combs
%A Daniel Habermehl
%A Tom Ganten
%A Jan Schmidt
%A Lutz Edler
%A Iris Burkholder
%A Oliver J£¿kel
%A Thomas Haberer
%A J¨¹rgen Debus
%J BMC Cancer
%D 2011
%I BioMed Central
%R 10.1186/1471-2407-11-67
%X Radiation therapy is a treatment alternative, however, high local doses are required for long-term local control. However, due to the relatively low radiation tolerance of liver normal tissue, even using stereotactic techniques, delivery of sufficient doses for successful local tumor control has not be achieved to date.Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 3 depending on the HCC cell line as well as the endpoint analyzed.Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for patients with HCC.In the current Phase I-PROMETHEUS-01-Study, carbon ion radiotherapy will be evaluated for patients with advanced HCC. The study will be performed as a dose-escalation study evaluating the optimal carbon ion dose with respect to toxicity and tumor control.Primary endpoint is toxicity, secondary endpoint is progression-free survival and response.The Prometheus-01 trial ist the first trial evaluating carbon ion radiotherapy delivered by intensity-modulated rasterscanning for the treatment of HCC. Within this Phase I dose escalation study, the optimal dose of carbon ion radiotherapy will be determined.NCT 01167374Primary liver cancer is the fifth most common neoplasm in the world, and the third most common cause of cancer-related death; of those, hepatocellular carcinoma (HCC) amounts to about 75-90% [1]. More than 600 000 new cases are diagnosed yearly, with and incidence of 5.5 to 14.9 per 100 000 [2,3]. In some areas of Asia, HCC is endemic, and is the most common cause of death due to cancer [4,5]. In Europe and the USA, HCC has shown an increase in incidence over the last years, which is attributed to an increase in Hep
%U http://www.biomedcentral.com/1471-2407/11/67