Randomised prospective phase II trial in multiple brain metastases comparing outcomes between hippocampal avoidance whole brain radiotherapy with or without simultaneous integrated boost: HA-SIB-WBRT study protocol.
Randomised prospective phase II trial in multiple brain metastases comparing outcomes between hippocampal avoidance whole brain radiotherapy with or without simultaneous integrated boost: HA-SIB-WBRT study protocol.
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DOI：
10.1186/s12885-020-07565-y
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发表时间：
2020-10-30
期刊：
影响因子：
3.8
通讯作者：
Lee TS
中科院分区：
文献类型：
--
作者：
Chia BSH;Leong JY;Ong ALK;Lim C;Poon SH;Chua MLK;Chua KLM;Kusumawidjaja G;Chua ET;Wong FY;Lee TS
最近的证据支持海马回避全脑放疗（HA-WBRT）作为预后良好和多发性脑转移患者的推荐治疗选择，因为与全脑放疗相比，这可以更好地保护神经认知。然而，由于给药剂量低，这种技术往往不能很好地控制肿瘤。立体定向放射外科（SRS）是一种集中放疗，用于脑转移数量有限的患者，它向转移灶提供更高的辐射剂量，从而更好地控制靶病变。随着放射技术的进步，先进的剂量绘制技术现在可以同时对病变进行综合增强（SIB）剂量，同时将对海马体的剂量降至最低，从而潜在地改善脑肿瘤控制并保持认知结果。该技术缩写为ha - sibb - wbrt或HA-WBRT+SIB。我们假设，与HA-WBRT（对照组）相比，ha - sibb - wbrt（实验组）中的SIB将导致更好的肿瘤控制。这也可能导致更好的颅内疾病控制以及功能和生存结果。我们的目标是在表现良好、多发性脑转移（4-25个病灶）和合理预期寿命（6个月）的患者中进行一项前瞻性随机II期试验。这些患者将根据脑转移的数量进行分层，并随机分为两组。我们的目标是在2年内从一个中心招募100名患者。我们的主要目的是控制靶病变。这些患者将在接下来的一年里接受随访，并在设定的时间点收集影像学、毒性、生活质量、日常生活活动和认知测量的数据。结果将在两臂之间进行比较和分析。脑转移患者的寿命更长。因此，维持功能独立性和颅内疾病控制变得越来越重要。改善放射治疗技术可以提供更好的控制和生存结果，同时保持生活质量，认知和功能能力。该试验将评估给HA-WBRT注射SIB的益处和可能的毒性。Clinicaltrials.gov识别码：NCT04452084。注册日期2020年6月30日。
Recent evidence supports hippocampal avoidance with whole brain radiotherapy (HA-WBRT) as the recommended treatment option in patients with good prognosis and multiple brain metastases as this results in better neurocognitive preservation compared to whole brain radiotherapy. However, there is often poor tumour control with this technique due to the low doses given. Stereotactic Radiosurgery (SRS), a form of focused radiotherapy which is given to patients who have a limited number of brain metastases, delivers a higher radiation dose to the metastases resulting in better target lesion control. With improvements in radiation technology, advanced dose-painting techniques now allow a simultaneous integrated boost (SIB) dose to lesions whilst minimising doses to the hippocampus to potentially improve brain tumour control and preserve cognitive outcomes. This technique is abbreviated to HA-SIB-WBRT or HA-WBRT+SIB. We hypothesise that the SIB in HA-SIB-WBRT (experimental arm) will result in better tumour control compared to HA-WBRT (control arm). This may also lead to better intracranial disease control as well as functional and survival outcomes. We aim to conduct a prospective randomised phase II trial in patients who have good performance status, multiple brain metastases (4–25 lesions) and a reasonable life expectancy (> 6 months). These patients will be stratified according to the number of brain metastases and randomised between the 2 arms. We aim for a recruitment of 100 patients from a single centre over a period of 2 years. Our primary endpoint is target lesion control. These patients will be followed up over the following year and data on imaging, toxicity, quality of life, activities of daily living and cognitive measurements will be collected at set time points. The results will then be compared across the 2 arms and analysed. Patients with brain metastases are living longer. Maintaining functional independence and intracranial disease control is thus increasingly important. Improving radiotherapy treatment techniques could provide better control and survival outcomes whilst maintaining quality of life, cognition and functional capacity. This trial will assess the benefits and possible toxicities of giving a SIB to HA-WBRT. Clinicaltrials.gov identifier: NCT04452084. Date of registration 30th June 2020.
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