Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Numerical Rating Pain Scale (NRPS) Change in Patients
研究概览
简要总结
The purpose of this study is to determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months post-treatment.
详细描述
Eligible Vertebral Metastatic Lesion/s-> randomized-> SRT versus SRT+ VAP Stereotactic Radiation Therapy(SRT): 16 Gy X 1 Evaluation: prior to treatment; 1 month, 2-4 months, 5-6 months and 1 year post-treatment
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
- Single (Outcomes Assessor)
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
- •Age ≥ 18 years.
- •ECOG performance status 0-
- •Known histologically proven malignancy.
- •Localized osteolytic spine metastases from T7 to L5 demonstrated by MRI, CT, PET or bone scan: a solitary spine metastasis; two separate spine levels; or up to 3 separate sites (each site may have a maximal involvement of 2 contiguous vertebral bodies with or without a paraspinal mass of no more than 5 cm).
- •Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- •Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
- •Numerical Rating Pain Scale (NRPS) and movement-related pain score(MRPS) within two (2) weeks prior to registration.
- •The patient must have a score of ≥ 5 for at least one of the planned sites for SRT.
- •Patients must provide study specific informed consent prior to study entry.
- •Required Pre-treatment Evaluations: baseline Numerical Rating Pain Scale (NRPS), movement-related pain score, dose and frequency of all pain medications; QOL Measure using the Oswestry Disability Questionnaire, and EuroQOL(EQ-5D).
排除标准
- •Non-ambulatory patients.
- •Frank spinal cord compression or epidural compression within 3 mm of the spinal cord.
- •Osteoblastic vertebral metastasis.
- •Prior radiation to the index spine.
- •Patients with rapid neurologic decline.
研究组 & 干预措施
Control Group
Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only
干预措施: Stereotactic Radiation Therapy (Radiation)
Treatment Group
SRT with Vertebral Augmentation Procedure Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure
干预措施: SRT with Vertebral Augmentation Procedure (Radiation)
结局指标
主要结局
Numerical Rating Pain Scale (NRPS) Change in Patients
时间窗: For 6 months post treatment
To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score
次要结局
- Vertebra Measurement(For 1 year post treatment)
- Reduction of Pain Estimate(For 1 year post treatment)
- Feasibility Rate Estimation(For 1 year post treatment)
- Toxicity Rate Estimation(For 1 year post treatment)
- Quality of Life Estimate(For 1 year post treatment)
研究者
Shiao Yuo Woo
Chair-Radiation Oncology
University of Louisville