NCT00006456已完成2 期
Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less damage to normal tissue.
PURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating patients who have liver metastases, lung metastases, or other advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the feasibility of fractionated stereotactic body radiosurgery in patients with advanced extracranial tumors.
- Assess the toxicities of this treatment regimen in these patients.
- Determine tumor response and cause of death in these patients treated with this regimen.
OUTLINE: Patients receive fractionated stereotactic body radiosurgery over 30 minutes for 5-10 days for a total of 3 treatments.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 10-25 patients will be accrued within 2-3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed malignancy
- •Extracranial recurrent or metastatic disease or primary tumor not predicted to be controlled with standard radiotherapy
- •Incurable with any standard therapy
- •No tumors involving critical structures (e.g., mucosal surfaces (bowel or bladder) or heart)
- •Tumor visible by CT scan
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin less than 2.0 times upper limit of normal (ULN)
- •AST and ALT less than 5 times ULN
- •Creatinine less than 2.0 mg/dL
- •FEV1 greater than 0.75 L
- •No unsuitable size or geometric proportion that would preclude stereotactic immobilization
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 14 days since prior anticancer biologic therapy and recovered
- •Chemotherapy:
- •At least 14 days since prior anticancer chemotherapy and recovered
- •Endocrine therapy:
- •At least 14 days since prior anticancer endocrine therapy and recovered
- •Radiotherapy:
- •See Disease Characteristics
- •At least 14 days since prior anticancer radiotherapy and recovered
- •Not specified
排除标准
- 未提供
研究者
研究点 (1)
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