A Pilot Randomised Comparison of Dexamethasone 96 mg Versus 16 mg Per Day for Malignant Spinal Cord Compression Treated by Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Satisfactory recruitment
研究概览
简要总结
The study aimed to pilot the viability of a full scale randomised comparison of 2 steroid doses in malignant spinal cord compression, to establish safety of high dose dexamethasone in this setting in Australia, to test web registration and randomisation and to compare different functional outcome measures.
详细描述
Malignant spinal cord compression (MSCC) is an uncommon condition with an estimated annual incidence of 2.5 per 100,000. It is a dreaded complication of malignancy because of the severe impact paralysis and sphincter disturbance has on quality and duration of survival.
Rat models have demonstrated the effectiveness of high doses of steroids. Only three randomised controlled trials (RCTs) have been published. The first compared radiotherapy to laminectomy plus radiotherapy in a series of 29 patients and failed to show any significant differences The widespread commonly used dose of Dexamethasone in Australia at that time was 16 mg/24 hr and the main concern for implementing higher doses was the toxicity profile reported in the few small randomised comparisons available at the time.In view of the conflict between standard Australian practice versus published (overseas) guidelines, a randomised comparison was proposed in Australia. This study was a pilot study initiated to determine the viability of a large trial, to pilot the use of web technology for trial conduct and to determine clinically useful outcome measures apart from simple ambulation rates.
Comparisons: Patients randomised to receive either 16mg/24hr or 96mg/24hr dexamethasone.
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
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant spinal cord compression with at least one of pain, weakness, sensory disturbance or sphincter disturbance
- •Histology not required if prior biopsy proven malignancy
- •Any stage
- •Age >16 years
- •ECOG 1-3 prior to cord compression event
- •Minimum power 1 of 5 point scale Must not be paraplegic
- •Minimum expected survival 2 months
- •Relevant minimum lab values
- •Patients capable of childbearing using adequate contraception
- •Written informed consent
排除标准
- •Prior radiotherapy to within vertebral±one level affected by cord compression
- •Prior treatment for spinal cord compression at the current level
- •Histology is lymphoma or myeloma
- •Power less than 1 of 5
- •More than 12 hours after initiation of dexamethasone>4mg/24hr
- •Pre-existing co-morbid conditions - peptic ulceration or cardiac failure
- •Allergy to study medications
- •Multilevel cord compression or meningeal carcinomatosis
- •Pregnant or lactating
结局指标
主要结局
Satisfactory recruitment
时间窗: Failure to accrue 30 patients in 15 months will initiate early closure of this study.
Acceptable steroid toxicity rate at 28 days with reference to baseline.
时间窗: 28 days
次要结局
- Ambulation rates at 1 month(1 month)
- Barthel Index(Final analysis when all patients have been followed for 1 month)
- Functional Independence (FIM)(Final analysis when all patients have been followed for 1 month)
- Functional Improvement Score (FIS)within 2 weeks with reference to baseline(2 weeks)
- Pain(Final analysis when all patients have been followed for 1 month)