Stereotactic Body Radiotherapy and pedicLE Screw fixatioN During One Hospital Visit for Patients With Painful Unstable Spinal Metastases: A Randomized Trial (BLEND)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Physical functioning
研究概览
简要总结
The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgical stabilization with or without decompression for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of treatment, compared with the standard of care (surgery followed by radiotherapy as soon as the wound healed sufficiently).
详细描述
Rationale: Currently, patients with unstable spinal metastases receive surgical stabilization with/without decompression followed by conventional radiotherapy (cRT) or stereotactic body radiotherapy (SBRT) as soon as wound healing allows (at least 1 week). Advancements in radiotherapy techniques makes preoperative radiotherapy possible with sparing of the soft tissues overlying the surgical field. This makes it possible to shorten or even eliminate the time interval between surgery and radiotherapy. This will result in shorter and less hospital visits, earlier pain relief from irradiation, and faster return to systemic therapy without an increase in wound complications due to the short interval between surgery and radiotherapy.
Objective: The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgery for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of the treatment, compared with the standard of care (surgery followed by radiotherapy, i.e., CRT or SBRT).
Study design: A phase II randomized controlled trial within the PRospective Evaluation of interventional StudiEs on boNe metastases (PRESENT) cohort including patients with bone metastases, according to the Trials within Cohorts (TwiCs) design.
Study population: Patients with symptomatic (cervical, thoracic and/or lumbar) spinal metastases and impending spinal instability requiring radiotherapy and surgical stabilization with or without decompression.
Intervention: SBRT (with active dose-sparing of the surgical site) and surgical stabilization with or without decompression within 24 hours. The control group will receive the standard of care, which is surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
According to the TwiCs design, patients allocated to the control group are not informed about their role as a control in the trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic (cervical, thoracic and/or lumbar) spinal metastases from solid tumors and (impending) spinal instability requiring radiotherapy and surgical decompression and/or stabilization
- •Histologic proof of malignancy or radiographic/clinical characteristics indicating malignancy beyond reasonable doubt
- •Radiographic evidence of spinal metastases
- •Participation in PRESENT cohort, including consent for randomization into future trials
- •Fit for (radio)surgery
- •Age >18 years
- •Written informed consent
排除标准
- •SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain
- •Routine surgical decompression and/or stabilization and radiotherapy cannot be performed, e.g., multiple spinal metastases requiring surgical bridging of more than five vertebral levels and/or requiring radiotherapy on more than one location
- •Prior surgery or radiotherapy to the index level(s)
- •Multiple myeloma
- •Neurological deficits (ASIA C, B or A), or partial neurological deficits (ASIA D) with rapid progression (hours to days)
- •Treated with Bevacizumab and other medication with long half-life that interferes with radiotherapy
- •Life expectancy of less than 3 months
研究组 & 干预措施
Intervention
Patients will receive high dose, single fraction stereotactic body radiotherapy (SBRT) using differential dosing: 18 or 21 Gy on the metastasis. Within 24 hours after SBRT, patients will have surgical stabilization with or without decompression.
干预措施: Same-day SBRT and spinal surgery (Other)
Control
Patients will undergo the standard of care, which is surgical stabilization with or without decompression, followed by conventional radiotherapy (cRT) or SBRT as soon as the wound is healed sufficiently.
干预措施: Standard of care (Other)
结局指标
主要结局
Physical functioning
时间窗: at 4 weeks after the start of treatment
Physical functioning is a functional scale from the EORTC QLQ-C15-PAL questionnaire. Patients rate each item on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much), and scale scores were linearly transformed to a 0-100 scale. A higher score on the functional scale indicates better functioning.
次要结局
- Local control(up to 12 months)
- Pain response(at 2, 4, 6 and 8 weeks, and 3 months after the start of treatment)
- Days until return to systemic treatment(up to 12 months)
- Duration of pain relief(up to 3 months)
- Adverse events(up to 3 months)
- Progression free survival(up to 12 months)
- Duration of hospital stay(up to 3 months)
- Neurological deterioration(up to 12 months)
- Overall survival(up to 12 months)
- Change in health-related quality of life(at 4 and 8 weeks, and 3 and 6 months after the start of treatment)
研究者
Helena M Verkooijen
Prof. H.M. Verkooijen
UMC Utrecht