A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Pain Response
研究概览
简要总结
The objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (RT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Skeletal metastasis with localized pain not controlled medically [recall within last 24 hours of worst pain ≥ 5 using the BPI]
- •2. Pain must be from one painful metastatic lesion involving the bone (additional less painful metastatic sites may be present). Extra-osseous extension of disease is allowed (must have some contact with the bone and be causing bone/tumor interface pain)
- •3. Lesions that are at high-risk of skeletal related events defined as follows:
- •a. Minimum Spinal Instability Neoplastic Score (SINS) score ≥ 7 for lesions involving the spine
- •b. Pelvic and appendicular lytic lesions with or without cortical breakthrough causing functional/mechanical pain
- •4. Target lesion amenable to percutaneous ablation with image guidance AND RT by specialists' review
- •5. No prior targeted radiation therapy or ablation to the index lesion
- •6. ECOG performance status 0-2
- •7. Age ≥ 21 years
- •8. Have signed the current approved informed consent form
- •9. Willing and able to answer follow-up Patient Reported Outcomes (PRO) surveys (e.g., PROMIS®, BPI, COST-FACIT, and OMED) for up to 12 months
- •10. Life expectancy > 3 months
排除标准
- •1. Any medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial.
- •2. Target tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone [MIREL Score ≥ 7]
- •3. Skeletal lesions with unstable pathologic fractures requiring immediate surgical stabilization
- •4. Concurrent participation in other studies that could affect the primary endpoint
- •5. Target tumor causing clinical or imaging evidence of spinal cord compression
结局指标
主要结局
Pain Response
时间窗: 3 Months
Combined partial and complete pain response rate using the Brief Pain Inventory (BPI), worst pain 24-hour recall, at 3 months following percutaneous ablation and palliative RT as defined by International Consensus on Palliative Radiotherapy Endpoints in clinical trials (ICPRE). • Partial response is defined as pain reduction of 2 or more at the treated site on a scale of 0 to 10 scale without analgesic increase, or analgesic reduction of 25% or more from Baseline without an increase in pain. • Complete response is defined as a pain score of 0 at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily OMED).
次要结局
未报告次要终点