A Phase II Randomized Trial of Combined Radiotherapy and Vertebroplasty to Improve the Quality of Life of Patients With Painful Metastatic Localized Spinal Lesions
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Improvement in Pain Score based on the Brief Pain Inventory
研究概览
简要总结
Since patients with spinal metastases are living longer, durable palliation with long-term tumor control are becoming increasingly important.
EBRT results in durable local control of bone metastasis. However, about 25 % of patients with spinal metastases only achieved complete pain relief following EBRT for a median duration of less than 4 months. This could be partly due to spinal instability. In addition, almost half of the patients who receive EBRT will subsequently develop VCFs . Hence, RT does not stabilize the spine secondary to VCFs and is not effective in preventing imminent VCFs. Vertebroplasty has rapidly reduced pain and improved function in patients with VCFs. However, vertebroplasty does not provide local tumor control similar to EBRT.
It is theorized that combining vertebroplasty with EBRT will stabilize the spine, relieve the pain, prevent imminent VCFs and minimize or avoid the need for opioids. It is hypothesized that combining a spine stabilization procedure such as vertebroplasty with RT will be the most effective management for patients with spinal metastases than RT alone for patients with spinal metastases. Combined vertebroplasty and radiotherapy is not a standard treatment option at present. This study is designed to quantify the advantage of adding vertebroplasty to radiotherapy for patients with spinal metastases. If the study is proven to be significant, it could become the standard of care for patients with spinal metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
- •Patients must be 18 years of age or older
- •Spinal vertebral metastases confirmed by CT, MRI or bone scan.
- •Patients with painful (VAS of at least ≥ 2) vertebral spinal metastases in the thoracic and /or lumbar spine (not cervical).
- •Patients must be willing and able to comply with schedule visits, treatment plan, tests and other study procedures
- •Life expectancy > 6 months. Life expectancy will be evaluated by the study investigator both clinically and by using Linden model. Patient should be in the group B or C of the Linden model.
- •Patients with an ECOG score 0-2 or Karnofsky performance status of ≥ 60% will be eligible for enrolment (see appendix 1).
- •No prior EBRT to the target +/-1 vertebral body level
- •Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause
- •Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard) .
- •Females must not breastfeed during study treatment.
- •Male patients should agree to not donate sperm during study treatment.
- •Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration
- •Exclusion Criteria
- •Patient cannot provide consent
- •Prior radiotherapy to the target +/-1 vertebral body level
- •Life expectancy < 6 months (assessed both clinically and using Linden model)
- •Karnofsky performance status of < 60%
- •Primary bone tumors
- •Plasmacytoma
- •Communicated fracture
- •Associated Impending cord compression or spinal cord compression
- •Epidural involvement
排除标准
- 未提供
结局指标
主要结局
Improvement in Pain Score based on the Brief Pain Inventory
时间窗: 1,3,6 and 12 months post treatment
The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the Brief Pain Inventory (BPI) without concurrent increase in opioids.
Improvement in Pain Score based on the Visual Analog Scale
时间窗: 1,3,6 and 12 months post treatment
The primary end point is the improvement in pain score of at least 2 points (a decrease of 2 points) on the visual analogue Scale (VAS) without concurrent increase in opioids.
次要结局
- Changes in back-specific physical functioning(1,3,6 and 12 months post treatment)
- Prospectively quantify pain response using the Visual Analog Scale(1,3,6 and 12 months post treatment)
- Prospectively quantify pain response using the Brief Pain Inventory.(1,3,6 and 12 months post treatment)
- Incidence of vertebral compression fractures post treatment.(Baseline, 6 months and 12 months)