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质子与碳离子放疗治疗颅底脊索瘤的随机对照临床试验,HIT-1 研究,临床 III 期研究。

Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study.

机构信息

Dept. of Clinical Radiology, University of Heidelberg, INF 400, 69120 Heidelberg, Germany.

出版信息

BMC Cancer. 2010 Nov 5;10:607. doi: 10.1186/1471-2407-10-607.

Abstract

BACKGROUND

Chordomas of the skull base are relative rare lesions of the bones. Surgical resection is the primary treatment standard, though complete resection is nearly impossible due to close proximity to critical and hence also dose limiting organs for radiation therapy. Level of recurrence after surgery alone is comparatively high, so adjuvant radiation therapy is very important for the improvement of local control rates. Proton therapy is the gold standard in the treatment of skull base chordomas. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors.

METHODS/DESIGN: This clinical study is a prospective randomised phase III trial. The trial will be carried out at Heidelberger Ionenstrahl-Therapie centre (HIT) and is a monocentric study.Patients with skull base chordoma will be randomised to either proton or carbon ion radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization and target volume delineation will be carried out based on CT and MRI data. The biologically isoeffective target dose to the PTV in carbon ion treatment (accelerated dose) will be 63 Gy E ± 5% and 72 Gy E ± 5% (standard dose) in proton therapy respectively. Local-progression free survival (LPFS) will be analysed as primary end point. Toxicity and overall survival are the secondary end points. Additional examined parameters are patterns of recurrence, prognostic factors and plan quality analysis.

DISCUSSION

Up until now it was impossible to compare two different particle therapies, i.e. protons and carbon ions directly at the same facility.The aim of this study is to find out, whether the biological advantages of carbon ion therapy can also be clinically confirmed and translated into the better local control rates in the treatment of skull base chordomas.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01182779.

摘要

背景

颅底脊索瘤是相对罕见的骨肿瘤。手术切除是主要的治疗标准,但由于与关键器官非常接近,这些器官也是放疗的剂量限制器官,因此几乎不可能完全切除。单纯手术后的复发率相对较高,因此辅助放疗对于提高局部控制率非常重要。质子治疗是颅底脊索瘤治疗的金标准。然而,高传能线密度(LET)射线如碳离子通过在生长缓慢的肿瘤中提高生物有效性,理论上具有生物学优势。

方法/设计:这是一项前瞻性随机 III 期临床试验,将在海德堡离子束治疗中心(HIT)进行,为单中心研究。颅底脊索瘤患者将被随机分配接受质子或碳离子放疗。作为标准治疗,患者将接受非侵入性的刚性固定,靶区勾画将根据 CT 和 MRI 数据进行。碳离子治疗中 PTV 的生物等效靶剂量(加速剂量)分别为 63 GyE ± 5%和 72 GyE ± 5%(标准剂量)。局部无进展生存期(LPFS)将作为主要终点进行分析。毒性和总生存期为次要终点。还将检查复发模式、预后因素和计划质量分析等参数。

讨论

到目前为止,还不可能在同一设施中直接比较两种不同的粒子治疗方法,即质子和碳离子。本研究的目的是确定碳离子治疗的生物学优势是否也能在临床上得到证实,并转化为颅底脊索瘤治疗中更好的局部控制率。

试验注册

ClinicalTrials.gov 标识符:NCT01182779。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce4a/2988755/9289e6a27eac/1471-2407-10-607-1.jpg

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