Division of Radiation Oncology, National Cancer Centre Singapore, 11 Hospital Crescent, Singapore, 169610, Singapore.
Department of Adult Neuro-developmental Service, Institute of Mental Health Singapore, 10 Buangkok View, Singapore, 539747, Singapore.
BMC Cancer. 2020 Oct 30;20(1):1045. doi: 10.1186/s12885-020-07565-y.
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.
最近的证据支持在预后良好且有多个脑转移病灶的患者中采用海马回避全脑放疗（HA-WBRT）作为推荐的治疗选择，因为与全脑放疗相比，这可以更好地保护神经认知功能。然而，由于给予的剂量较低，该技术通常肿瘤控制效果较差。立体定向放射外科（SRS）是一种聚焦放疗形式，适用于脑转移病灶数量有限的患者，它向转移病灶给予更高的辐射剂量，从而更好地控制靶病灶。随着放射技术的进步，先进的剂量绘制技术现在可以在对海马体最小化剂量的同时对病灶进行同步整合增敏（SIB）剂量，从而有可能提高脑肿瘤的控制效果并保持认知功能的结果。该技术缩写为 HA-SIB-WBRT 或 HA-WBRT+SIB。
我们假设 HA-SIB-WBRT（实验组）中的 SIB 将比 HA-WBRT（对照组）产生更好的肿瘤控制效果。这也可能导致更好的颅内疾病控制以及功能和生存结果。我们计划在有良好表现状态、多个脑转移病灶（4-25 个病灶）和合理预期寿命（>6 个月）的患者中开展一项前瞻性随机 II 期试验。这些患者将根据脑转移病灶的数量进行分层，并在 2 个臂之间进行随机分组。我们计划在 2 年内从一个中心招募 100 名患者。我们的主要终点是靶病灶控制。这些患者将在接下来的 1 年内进行随访，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。然后将对 2 个臂的数据进行比较和分析。
脑转移患者的生存期延长。因此，维持功能独立性和颅内疾病控制变得越来越重要。改进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。该试验将评估对 HA-WBRT 进行 SIB 的益处和可能的毒性。
Clinicaltrials.gov 标识符：NCT04452084。注册日期 2020 年 6 月 30 日。
