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临床试验/NCT00188864
NCT00188864已完成2 期

Dexamethasone as Palliative Treatment in Addition to Radiation Therapy for Patients With Brain Metastases: A Prospective Study

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2003年11月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
2
主要终点
To perform an adequate statistical evaluation of patients regarding the role of steroid therapy in managing patients with cerebral metastases.

研究概览

简要总结

Brain metastases occur when cancer cells from the initial tumour site (for example, lung or breast) spread to the brain. This develops in approximately 10% - 30% of adults with cancer. They can produce different complaints related to their effect on brain functioning, decrease in a person's ability to carry on with their usual activities, a reduction in the quality of life and shortened life expectancy.

The standard treatment particularly for people with more than one brain metastasis consists of palliative radiation therapy to the brain and steroids. Steroids (such as Decadron or Dexamethasone) are medication used to reduce swelling around the tumour, and thus symptoms improve. Steroids could be very helpful but have a number of potential side effects, particularly if used for longer periods of time. There is no standard dose of Decadron used in treating brain metastases patients. The most commonly dose used is 4 mg four times/day.

This study will assess if lower doses of Decadron - 8 mg every morning for symptomatic patients and 4 mg every morning for asymptomatic patients - are effective in maintaining symptom control in patients with brain metastases, without neurological deterioration that necessitates the patient to go back or to a higher dose at any time. This information will help also in understanding how to decrease the side effects associated with higher doses of steroids in people with your condition.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Known diagnosis of cancer (even if primary unknown)
  • Brain metastases (single or multiple) confirmed by imaging (CT, MRI)
  • No contraindication for RT/steroids
  • Patient will be treated with Whole Brain Radiation Therapy
  • Informed consent

排除标准

  • Primary cancer is lymphoma or leukemia
  • Complete surgical excision of brain metastases
  • Patient was on steroids for more then 2 weeks prior to entering the study
  • Confusion or other factors that would impair ability to assess symptoms

结局指标

主要结局

To perform an adequate statistical evaluation of patients regarding the role of steroid therapy in managing patients with cerebral metastases.

次要结局

  • To observe whether DXM 8mg qAM for symptomatic patients and DXM 4mg qAM for asymptomatic patients is effective in maintaining symptom control without neurological deterioration that necessitates the patient to go back to a higher dose.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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