CyberKnife Center, Department of Neurosurgery, Huashan Hospital, Shanghai Medical College, Fudan University, 12 Wulumuqi Road (M), Shanghai, 200040, China.
National Center for Neurological Disorders, Shanghai, China.
BMC Cancer. 2022 Jul 29;22(1):827. doi: 10.1186/s12885-022-09914-5.
The most frequently diagnosed primary brain tumor is glioblastoma (GBM). Nearly all patients experience tumor recurrence and up to 90% of which is local recurrence. Thus, increasing the therapeutic ratio of radiotherapy using hypofractionated stereotactic radiotherapy (HSRT) can reduce treatment time and may increase tumor control and improve survival. To evaluate the efficacy and toxicity of the combination of HSRT and intensity-modulated radiotherapy (IMRT) with temozolomide after surgery in GBM patients and provide evidence for further randomized controlled trials.
METHODS/DESIGN: HSCK-010 is an open-label, single-arm phase II trial (NCT04547621) which includes newly diagnosed GBM patients who underwent gross total resection. Patients will receive the combination of 30 Gy/5fx HSRT, and 20 Gy/10fx IMRT adjuvant therapy with concurrent temozolomide and adjuvant chemotherapy. The primary endpoint is overall survival (OS). Secondary outcomes include progression-free survival (PFS) rate, objective-response rate (ORR), quality of life (Qol) before and after the treatment, cognitive function before and after the treatment, and rate of treatment-related adverse events (AE). The combination of HSRT and IMRT with temozolomide can benefit the patients after surgery with good survival, acceptable toxicity, and reduced treatment time.
NCT04547621 . Registered on 14 September 2020.
最常诊断的原发性脑肿瘤是胶质母细胞瘤（GBM）。几乎所有患者都经历肿瘤复发，其中多达 90%为局部复发。因此，通过使用立体定向适形大分割放疗（HSRT）来提高放疗的治疗比，可以减少治疗时间，并可能增加肿瘤控制和改善生存。评估手术后 HSRT 联合替莫唑胺的强度调制放疗（IMRT）在 GBM 患者中的疗效和毒性，为进一步的随机对照试验提供证据。
方法/设计：HSCK-010 是一项开放标签、单臂 II 期试验（NCT04547621），纳入接受了大体全切除的新诊断 GBM 患者。患者将接受 30Gy/5fx HSRT 和 20Gy/10fx IMRT 辅助治疗，联合替莫唑胺同步放化疗。主要终点是总生存期（OS）。次要结局包括无进展生存期（PFS）率、客观缓解率（ORR）、治疗前后的生活质量（Qol）、治疗前后的认知功能以及治疗相关不良事件（AE）的发生率。HSRT 联合 IMRT 与替莫唑胺联合治疗可使术后患者受益，具有良好的生存、可接受的毒性和缩短治疗时间。
NCT04547621。于 2020 年 9 月 14 日注册。
