Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.
研究概览
详细说明
OBJECTIVES:
- To identify the maximum tolerated dose of stereotactic radiation therapy in patients with hepatic metastases.
- To determine the toxicity and adverse events profile of this patient population.
- To examine patient response, treatment effect on blood chemistry, and hematology values and patient quality-of-life in this patient population.
OUTLINE: Patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3) and the number of liver lesions present (1-2 vs 3-5 vs > 5).
Patients undergo percutaneous placement of metallic fiducial markers within the liver for stereotactic targeting and planning. Patients then undergo 1 fraction of stereotactic radiotherapy within 1 week of the marker placement.
Patients complete Brief Pain Inventory and Brief Fatigue Inventory questionnaires to assess quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study treatment.
After completion of study treatment, patients are followed for at least 8 weeks.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Florida
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Jacksonville、Florida、美国、32224
- Mayo Clinic - Jacksonville
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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:
- Metastatic liver lesion ≤ 5 cm in dimension
- Willing and able to undergo percutaneous placement of localization seeds
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 12 weeks
- Platelet count ≥ 75,000/µL
- Hemoglobin ≥ 9 g/dL
- ANC ≥ 1,500/mL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST ≤ 3 x ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to complete questionnaires alone or with assistance
- No medical, social, or economic circumstance, that is likely to prevent adherence with the protocol
PRIOR CONCURRENT THERAPY:
- No prior radiation therapy to the liver
- No chemotherapy ≤ 4 weeks prior to registration
- Able to safely go without chemotherapy for 4 weeks after stereotactic radiotherapy (e.g., patients must not have or need chemotherapy in the 8 weeks [4 weeks prior to and 4 weeks after registration] surrounding stereotactic radiotherapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
研究衡量的是什么？
主要结果指标
结果测量 |
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最大耐受剂量
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次要结果测量
结果测量 |
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毒性概况
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不良事件概况
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Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
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Response profile
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Physical exam results
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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 (实际的)
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 (实际的)
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.