Department of Radiation Oncology, University Hospital of Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
BMC Cancer. 2010 Nov 9;10:615. doi: 10.1186/1471-2407-10-615.
Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50% and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control. 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 5 depending on the cell line as well as the endpoint analyzed.First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.
METHODS/DESIGN: The Phase II-MARCIE-Study will evaluate a carbon ion boost applied to the macroscopic tumor in conjunction with photon radiotherapy in patients with atypical meningiomas after incomplete resection or biopsy.Primary endpoint is progression-free survival, secondary endpoints are overall survival, safety and toxicity.
Based on published data on the treatment of atypical meningiomas with carbon ions at GSI, the present study will evaluate this treatment concept in a larger patient population and will compare outcome to current standard photon treatment.
NCT01166321.
对于非典型或间变性脑膜瘤患者，治疗标准是神经外科切除。采用这种方法，根据切除情况，局部控制率在 50%至 70%之间。一系列较小的研究表明，在这一患者群体中，术后放疗可以提高无进展生存率，从而提高总体生存率。然而，脑膜瘤是众所周知的放射抵抗性肿瘤，需要 60Gy 或更高的放射剂量才能控制肿瘤。碳离子具有物理和生物学特性。由于其剂量分布倒置，以及在布拉格峰内高局部剂量沉积，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，碳离子具有更高的相对生物效应（RBE），其值可根据细胞系和分析的终点在 2 到 5 之间计算。在达姆施塔特 GSI 进行的 I/II 期碳离子放射治疗高危脑膜瘤的试验中获得的初步数据显示了安全性，并且治疗结果很有希望。
方法/设计：II 期-MARCIE-研究将评估在不完全切除或活检后的非典型脑膜瘤患者中，将宏观肿瘤与光子放射治疗相结合应用碳离子增强治疗。主要终点是无进展生存率，次要终点是总生存率、安全性和毒性。
基于 GSI 发表的关于碳离子治疗非典型脑膜瘤的研究数据，本研究将在更大的患者群体中评估这一治疗方案，并将其结果与当前的标准光子治疗进行比较。
NCT01166321。
