A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Overall response rate (stabilization and response) (stage I)
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may be effective in treating malignant spinal cord compression in patients who have received previous radiation therapy to the spine.
PURPOSE: This phase II trial is studying radiation therapy in treating patients with malignant spinal cord compression.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy of a biologically effective dose-based re-irradiation strategy, in terms of the response rate (based on the mobility score using the Tomita scale where improvement in mobility or stable mobility score will be regarded as a response) in patients with malignant spinal cord compression.
Secondary
- To determine quality of life as assessed by the EORTC QLQ-C15 PAL version 1.0 questionnaire.
- To determine the non-spinal radiation-induced toxicity using standard RTOG criteria.
- To determine the rate of long-term spinal toxicity and radiation-induced myelopathy using the RTOG SOMA morbidity grading system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Radiation Cumulative BED ≤ 100 Gy2
干预措施: Cumulative BED ≤ 100 (Radiation)
B
Cumulative BED ≤ 130 Gy2
干预措施: Cumulative BED ≤ 130 Gy2 (Radiation)
结局指标
主要结局
Overall response rate (stabilization and response) (stage I)
时间窗: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Response to treatment as assessed by mobility via the Tomita mobility scale
时间窗: 5 weeks after completion of radiation therapy
次要结局
- Pain control via the pain visual analogue score(5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter)
- Median survival (time from the date of recruitment/treatment to death)(Until death)
- Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system(5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter)
- Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire(5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter)
- Toxicity other than spine (acute toxicity assessed at weeks 1 and 5 and late toxicity assessed at 3 months and at subsequent follow-ups) evaluated according to RTOG criteria(5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter)