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Clinical Trial
. 2011 Feb 12:11:67.
doi: 10.1186/1471-2407-11-67.

Phase i study evaluating the treatment of patients with hepatocellular carcinoma (HCC) with carbon ion radiotherapy: the PROMETHEUS-01 trial

Stephanie E Combs  1 , Daniel Habermehl, Tom Ganten, Jan Schmidt, Lutz Edler, Iris Burkholder, Oliver Jäkel, Thomas Haberer, Jürgen Debus
Affiliations
Clinical Trial

Phase i study evaluating the treatment of patients with hepatocellular carcinoma (HCC) with carbon ion radiotherapy: the PROMETHEUS-01 trial

Stephanie E Combs et al. BMC Cancer. .

Abstract

Background: Treatment options for patients with advanced hepatocellular carcinoma (HCC) are often limited. In most cases, they are not amenable to local therapies including surgery or radiofrequency ablation. The multi-kinase inhibitor sorafenib has shown to increase overall survival in this patient group for about 3 months.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.

Methods/design: 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.

Discussion: 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.

Trial registration: NCT 01167374.

Trial registration: ClinicalTrials.gov NCT01167374.

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Figures

Figure 1
Figure 1
Flow chart of the Prometheus-01 study.
See this image and copyright information in PMC

References

    1. Okuda K, Nakanuma Y, Miyazaki M. Cholangiocarcinoma: recent progress. Part 1: epidemiology and etiology. J Gastroenterol Hepatol. 2002;17:1049–55. doi: 10.1046/j.1440-1746.2002.02781.x. - DOI - PubMed
    1. Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001;94:153–6. doi: 10.1002/ijc.1440. - DOI - PubMed
    1. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005;55:74–108. doi: 10.3322/canjclin.55.2.74. - DOI - PubMed
    1. El Serag HB, Mason AC. Rising incidence of hepatocellular carcinoma in the United States. N Engl J Med. 1999;340:745–50. doi: 10.1056/NEJM199903113401001. - DOI - PubMed
    1. Tanaka Y, Hanada K, Mizokami M, Yeo AE, Shih JW, Gojobori T. et al. Inaugural Article: A comparison of the molecular clock of hepatitis C virus in the United States and Japan predicts that hepatocellular carcinoma incidence in the United States will increase over the next two decades. Proc Natl Acad Sci USA. 2002;99:15584–9. doi: 10.1073/pnas.242608099. - DOI - PMC - PubMed

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