Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression
SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Manchester、英国、M20 6UX
- Christie Hospital
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England
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Bristol、England、英国、BS2 8ED
- Bristol Haematology and Oncology centre
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Northwood、England、英国、HA6 2RN
- Cancer Research UK and University College London Cancer Trials Centre
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Wales
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Rhyl, Denbighshire、Wales、英国、LL 18 5UJ
- Glan Clwyd Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Arm I (multi-fraction radiotherapy)
Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
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Patients undergo external beam radiotherapy
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实验性的：Arm II (single-fraction radiotherapy)
Patients undergo 1 fraction of 8 Gy external beam radiotherapy.
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Patients undergo external beam radiotherapy
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研究衡量的是什么？
主要结果指标
结果测量 |
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Patient accrual per center over a 12-month period
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次要结果测量
结果测量 |
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Ambulatory status at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
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Bladder and bowel function at 1, 4, 8, and 12 weeks from day 1 of treatment compared to baseline
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Acute side effects using RTOG scales at 1, 4, 8, and 12 weeks from day 1 of treatment
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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
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Further treatment
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Overall survival at 3, 6, and 12 months
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Total number of days spent in hospital
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Preferred place of care
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Number of patients eligible but not randomized and reasons for non-randomization
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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