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BMC Cancer
Published in: BMC Cancer 1/2011

Open Access 01-12-2011 | Study protocol

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

Authors: Stephanie E Combs, Daniel Habermehl, Tom Ganten, Jan Schmidt, Lutz Edler, Iris Burkholder, Oliver Jäkel, Thomas Haberer, Jürgen Debus

Published in: BMC Cancer | Issue 1/2011

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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

NCT01167374
Appendix
Available only for authorised users
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Metadata
Title
Phase i study evaluating the treatment of patients with hepatocellular carcinoma (HCC) with carbon ion radiotherapy: The PROMETHEUS-01 trial
Authors
Stephanie E Combs
Daniel Habermehl
Tom Ganten
Jan Schmidt
Lutz Edler
Iris Burkholder
Oliver Jäkel
Thomas Haberer
Jürgen Debus
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2011
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-11-67

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