SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Patient accrual per center over a 12-month period
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression.
PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.
详细描述
OBJECTIVES:
- To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression.
- To determine the feasibility of conducting this study in the United Kingdom.
OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease [spinal metastases only vs spinal and non-bony metastases]). Patients are randomized to 1 of 2 treatment arms.
- Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
- Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed malignant disease
- •Proven diagnosis of metastatic spinal cord compression on MRI or CT scan
- •Single site of compression OR multiple sites that can be treated within a single radiation treatment field
- •No patient for whom surgery or chemotherapy treatment is more appropriate
- •No multiple myeloma as primary cancer
- •PATIENT CHARACTERISTICS:
- •Life expectancy > 1 month
- •Not pregnant
- •Willing and able to complete assessment forms
- •Able to give informed consent
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Arm I (multi-fraction radiotherapy)
Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
干预措施: radiation therapy (Radiation)
Arm II (single-fraction radiotherapy)
Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Patient accrual per center over a 12-month period
次要结局
- Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
- Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
- Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
- Quality of life as measured by the EORTC QLQ-C30 questionnaire at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
- Further treatment
- Overall survival at 3, 6, and 12 months
- Total number of days spent in hospital
- Preferred place of care
- Number of patients eligible but not randomized and reasons for non-randomization