A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
次要结局
- Physical exam results
- Adverse events profile
- Toxicity profile
- Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
- Response profile