NCT00255814已完成1 期
A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- To determine the maximally tolerated dose
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy in treating patients with liver metastases.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases.
Secondary
- Determine the failure patterns and survival of patients treated with this regimen.
- Correlate dose-volume characteristics with possible toxic effects of this regimen in these patients.
- Determine the local control rate within irradiated fields in patients treated with this regimen.
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
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Histologically confirmed non-lymphoma liver metastases
- •New radiographic liver lesions most consistent with metastases in a patient with known, histologically proven non-lymphoma cancer AND a previously negative CT scan, MRI, or PET/CT scan of the liver
- •No more than 5 measurable lesions by contrast-enhanced liver CT scan, MRI, or PET/CT scan
- •Liver metastases ≤ 8 cm
- •Medically unfit for surgery OR lesions are surgically unresectable
- •All intrahepatic disease must be encompassed within the study radiation field
- •Extrahepatic disease outside the liver is allowed provided the hepatic disease is life-limiting
- •At least 1,000 cc of normal liver
- •No clinical ascites
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,800/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8 g/dL (transfusion allowed)
- •No active hepatitis
- •No clinically significant liver failure
- •No underlying cirrhosis
- •Not specified
- •Cardiovascular
- •No congestive heart failure requiring hospitalization within the past 6 months
- •No unstable angina pectoris requiring hospitalization within the past 6 months
- •No transmural myocardial infarction within the past 6 months
- •No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, cervix or primary liver metastasis
- •No acute bacterial or fungal infection requiring IV antibiotics
- •PRIOR CONCURRENT THERAPY:
- •Chemotherapy
- •At least 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •No anthracyclines within 4 weeks after completion of study therapy (1 week for other chemotherapy)
- •Radiotherapy
- •No prior radiotherapy to the region of study
- •No concurrent intensity-modulated radiotherapy
- •Prior liver resection or ablative therapy allowed
- •No concurrent warfarin or IV heparin
排除标准
- 未提供
研究组 & 干预措施
Radiation therapy dose level II: 4.0 Gy/fx
Other
Radiation therapy dose level II: 4.0 Gy/fraction
干预措施: radiation therapy (Radiation)
Radiation therapy dose level III: 4.5 Gy/fx
Other
Radiation therapy dose level III: 4.5 Gy/fraction
干预措施: radiation therapy (Radiation)
Radiation therapy dose level IV: 5.0 Gy/fx
Other
Radiation therapy dose level IV: 5.0 Gy/fraction
干预措施: radiation therapy (Radiation)
结局指标
主要结局
To determine the maximally tolerated dose
时间窗: From start of treatment to 90 days
次要结局
未报告次要终点
研究者
研究点 (3)
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