替莫唑胺联合左乙拉西坦治疗胶质母细胞瘤术后的疗效：一项双盲随机对照试验研究方案。
The efficacy of temozolomide combined with levetiracetam for glioblastoma (GBM) after surgery: a study protocol for a double-blinded and randomized controlled trial.
机构信息
Department of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
出版信息
Trials. 2022 Mar 28;23(1):234. doi: 10.1186/s13063-022-06168-1.
BACKGROUND
Temozolomide is applied as the standard chemotherapy agent in patients with glioblastoma (GBM) after surgery. However, the benefit of this treatment for patients is limited by the invasive growth of gliomas and drug resistance. There are indications from fundamental experimental and retrospective studies that levetiracetam has the potential to improve the survival rate of patients with GBM. However, it has yet to be determined whether the combination of temozolomide and levetiracetam is more effective than standard temozolomide chemotherapy. Therefore, we designed a randomized clinical trial to investigate the therapeutic effect of the new combined regime for treating GBM.
METHODS/DESIGN: This is a double-blind and randomized clinical trial conducted in a single center. One hundred forty-two patients will be recruited and screened for the inclusion and exclusion criteria. Then, eligible participants will be randomly assigned to an experimental group or a control group in a 1:1 ratio. Based on the administration of radiation therapy (RT), participants in the experimental group will be prescribed levetiracetam plus temozolomide chemotherapy for 34 weeks while participants in the control group will receive placebo tablets plus temozolomide for the same duration. A 3-year follow-up will be conducted on all patients after intervention. Accordingly, the primary outcome will be progression-free survival (PFS). The secondary endpoints include overall survival (OS), the Karnofsky Performance Status (KPS), the objective response rate (ORR), and adverse event incidence.
DISCUSSION
It is expected that the results of this trial will provide high-level evidence regarding the clinical benefits of levetiracetam and temozolomide combined in the treatment of GBM.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR2100049941 . Registered on 14 August 2021.
背景
替莫唑胺被用作胶质母细胞瘤（GBM）患者手术后的标准化疗药物。然而，这种治疗对患者的益处受到胶质瘤的侵袭性生长和耐药性的限制。有基础实验和回顾性研究的迹象表明，左乙拉西坦有可能提高 GBM 患者的生存率。然而，替莫唑胺联合左乙拉西坦是否比标准替莫唑胺化疗更有效仍有待确定。因此，我们设计了一项随机临床试验，以研究新的联合方案治疗 GBM 的治疗效果。
方法/设计：这是一项在单一中心进行的双盲、随机临床试验。将招募 142 名患者进行纳入和排除标准的筛查。然后，符合条件的参与者将以 1:1 的比例随机分配到实验组或对照组。根据放射治疗（RT）的实施情况，实验组的参与者将接受左乙拉西坦联合替莫唑胺化疗 34 周，而对照组的参与者将接受安慰剂片剂联合替莫唑胺治疗相同的时间。所有患者在干预后将进行 3 年随访。因此，主要终点将是无进展生存期（PFS）。次要终点包括总生存期（OS）、卡氏功能状态评分（KPS）、客观缓解率（ORR）和不良事件发生率。
讨论
预计该试验的结果将为左乙拉西坦和替莫唑胺联合治疗 GBM 的临床获益提供高水平证据。
试验注册
中国临床试验注册中心，ChiCTR2100049941。于 2021 年 8 月 14 日注册。
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