Department of Neurosurgery, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
Department of Anesthesiology, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
BMJ Open. 2021 Jun 1;11(6):e046043. doi: 10.1136/bmjopen-2020-046043.
Craniopharyngioma is the most challenging to treat brain tumour with high recurrence rates, which can be effectively reduced by adjuvant radiotherapy. In recent years, proton therapy (PT), with its physical properties of heavy ion beam, that is, Prague peak phenomenon, has been more frequently used in patients with craniopharyngioma. Compared with conventional X-ray beam radiotherapy, PT can reduce the damage to normal tissues and enlarge the damage to tumours. Some studies have shown that PT has advantages in the treatment of craniopharyngioma in adults. However, the optimal management of craniopharyngioma remains controversial. The purpose of this study was to evaluate the efficacy and safety of PT for craniopharyngioma in adults.
We will search six databases (MEDLINE, EMBASE, Web of Science, the Cochrane Library, Amed, Scopus), clinical research registration websites and grey literature, aiming to identify randomised controlled trials (RCTs) on PT for craniopharyngioma in adults between 1 January 1954 and 28 September 2021. In the RCTs, PT will be used as the intervention group, and conventional X-ray beam radiotherapy will be used as the comparator group. Tumour recurrence and survival will be the primary outcome, and treatment-related toxicity will be the secondary outcome. The study selection, data extraction, bias risk and quality evaluation will be operated by two to four researchers independently. We will use Review Manager V.5.2 (RevMan V.5.2) for data analysis. If there is significant heterogeneity, we will identify the source of heterogeneity by subgroup analysis.
Our study is based on existing RCTs and does not require ethical approval. The results of the study will be published in a peer-reviewed journal or at a related conference.
CRD42020200909.
颅咽管瘤是治疗难度最大的脑肿瘤之一，复发率高，辅助放疗可有效降低复发率。近年来，质子治疗（PT）因其重离子束的物理特性，即布拉格峰现象，在颅咽管瘤患者中应用越来越频繁。与常规 X 射线放疗相比，PT 可以降低对正常组织的损伤，扩大对肿瘤的损伤。一些研究表明，PT 在成人颅咽管瘤的治疗中具有优势。然而，颅咽管瘤的最佳治疗方法仍存在争议。本研究旨在评估 PT 治疗成人颅咽管瘤的疗效和安全性。
我们将检索 6 个数据库（MEDLINE、EMBASE、Web of Science、Cochrane 图书馆、Amed、Scopus）、临床研究注册网站和灰色文献，旨在确定 1954 年 1 月 1 日至 2021 年 9 月 28 日期间成人颅咽管瘤 PT 的随机对照试验（RCT）。在 RCT 中，PT 将作为干预组，常规 X 射线放疗将作为对照组。肿瘤复发和生存将作为主要结局，治疗相关毒性将作为次要结局。研究选择、数据提取、偏倚风险和质量评价将由 2 至 4 名研究人员独立进行。我们将使用 Review Manager V.5.2（RevMan V.5.2）进行数据分析。如果存在显著异质性，我们将通过亚组分析确定异质性的来源。
我们的研究基于现有的 RCT，不需要伦理批准。研究结果将发表在同行评议的期刊或相关会议上。
PROSPERO 注册号：CRD42020200909。
