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Open Access Highly Accessed Study protocol

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

Stephanie E Combs1*, Daniel Habermehl1, Tom Ganten2, Jan Schmidt3, Lutz Edler4, Iris Burkholder5, Oliver Jäkel6, Thomas Haberer6 and Jürgen Debus1

Author Affiliations

1 Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany

2 Department of Gastroenterology, University Hospital of Heidelberg, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany

3 Department of Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany

4 German Cancer Research Center (dkfz), Department of Biostatistics, Im Neuenheimer Feld 290, 69120 Heidelberg, Germany

5 Statistische und Biometrische Lösungen, Pistorstr. 7, 66482 Zweibrücken, Germany

6 Heidelberger Ionenstrahl Therapiezentrum (HIT), Im Neuenheimer Feld 450, 69120 Heidelberg, Germany

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BMC Cancer 2011, 11:67  doi:10.1186/1471-2407-11-67

Published: 12 February 2011

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