Division of Imaging and Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Department of Radiology, Isala Hospital, Zwolle, The Netherlands.
Trials. 2022 Dec 29;23(1):1061. doi: 10.1186/s13063-022-06942-1.
Cancer-induced bone pain (CIBP), caused by bone metastases, is a common complication of cancer and strongly impairs quality of life (QoL). External beam radiotherapy (EBRT) is the current standard of care for treatment of CIBP. However, approximately 45% of patients have no adequate pain response after EBRT. Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) may improve pain palliation in this patient population. The main objective of this trial was to compare MR-HIFU, EBRT, and MR-HIFU + EBRT for the palliative treatment of bone metastases.
METHODS/DESIGN: The FURTHER trial is an international multicenter, three-armed randomized controlled trial. A total of 216 patients with painful bone metastases will be randomized in a 1:1:1 ratio to receive EBRT only, MR-HIFU only, or combined treatment with EBRT followed by MR-HIFU. During a follow-up period of 6 months, patients will be contacted at eight time points to retrieve information about their level of pain, QoL, and the occurrence of (serious) adverse events. The primary outcome of the trial is pain response at 14 days after start of treatment. Secondary outcomes include pain response at 14 days after trial enrolment, pain scores (daily until the 21st day and at 4, 6, 12 and 24 weeks), toxicity, adverse events, QoL, and survival. Cost-effectiveness and cost-utility analysis will be conducted.
The FURTHER trial aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU-alone or in combination with EBRT-compared to EBRT to relieve CIBP. The trial will be performed in six hospitals in four European countries, all of which are partners in the FURTHER consortium.
The FURTHER trial is registered under the Netherlands Trials Register number NL71303.041.19 and ClinicalTrials.gov registration number NCT04307914. Date of trial registration is 13-01-2020.
癌症引起的骨痛（CIBP）是由骨转移引起的常见癌症并发症，严重影响生活质量（QoL）。外束放射治疗（EBRT）是目前治疗 CIBP 的标准治疗方法。然而，大约 45%的患者在 EBRT 后没有得到足够的疼痛缓解。磁共振引导高强度聚焦超声（MR-HIFU）可能改善这部分患者人群的疼痛缓解。本试验的主要目的是比较 MR-HIFU、EBRT 和 MR-HIFU+EBRT 治疗骨转移的姑息治疗效果。
方法/设计：FURTHER 试验是一项国际多中心、三臂随机对照试验。共 216 例有疼痛性骨转移的患者将以 1:1:1 的比例随机分为 EBRT 组、MR-HIFU 组或 EBRT 联合 MR-HIFU 组。在 6 个月的随访期间，将在 8 个时间点联系患者，以获取其疼痛程度、生活质量和（严重）不良事件发生情况的信息。试验的主要终点是治疗开始后 14 天的疼痛反应。次要终点包括试验入组后 14 天的疼痛反应、疼痛评分（第 1 天至第 21 天，以及第 4、6、12 和 24 周）、毒性、不良事件、生活质量和生存情况。将进行成本效益和成本效用分析。
FURTHER 试验旨在评估 MR-HIFU 单独或联合 EBRT 与 EBRT 缓解 CIBP 的有效性和成本效益。该试验将在欧洲四个国家的六家医院进行，这些医院都是 FURTHER 联盟的合作伙伴。
FURTHER 试验在荷兰试验注册数据库中注册，注册号为 NL71303.041.19，在美国临床试验数据库中注册，注册号为 NCT04307914。试验注册日期为 2020 年 1 月 13 日。
