Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
BMC Cancer. 2011 Feb 12;11:67. doi: 10.1186/1471-2407-11-67.
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.
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 01167374.
对于晚期肝细胞癌（HCC）患者的治疗选择通常有限。在大多数情况下，他们不适合接受局部治疗，包括手术或射频消融。多激酶抑制剂索拉非尼已显示在该患者群体中可将总生存期延长约 3 个月。放射治疗是一种治疗选择，但是，为了长期局部控制，需要高局部剂量。然而，由于肝脏正常组织的相对辐射耐受性较低，即使使用立体定向技术，也尚未达到成功局部肿瘤控制所需的足够剂量。碳离子具有物理和生物学特性。由于其剂量倒转分布和布拉格峰内的高局部剂量沉积，精确的剂量应用和正常组织的保护成为可能。此外，与光子相比，碳离子提供了更高的相对生物学效应（RBE），这可以根据 HCC 细胞系以及分析的终点在 2 到 3 之间进行计算。日本对碳离子放射治疗评估的数据显示，对于 HCC 患者，该治疗方法具有良好的效果。
方法/设计：在当前的 I 期 PROMETHEUS-01 研究中，将评估碳离子放射疗法对晚期 HCC 患者的疗效。该研究将作为剂量递增研究进行，旨在评估毒性和肿瘤控制方面的最佳碳离子剂量。主要终点是毒性，次要终点是无进展生存期和反应。
Prometheus-01 试验是评估强度调制光栅扫描碳离子放射治疗 HCC 的首个试验。在这项 I 期剂量递增研究中，将确定碳离子放射治疗的最佳剂量。
NCT 01167374。
