NCT00469963终止不适用
Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Tumor response
研究概览
简要总结
RATIONALE: Specialized internal 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 clinical trial is studying how well internal radiation therapy works in treating patients with primary liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine tumor response to selective internal radiation therapy comprising yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with unresectable primary hepatocellular carcinoma.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the health-related quality of life of patients receiving this regimen.
- Determine the survival of patients receiving this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hepatocellular carcinoma
- •Not amenable to surgical resection or immediate liver transplantation
- •Destaging of tumor prior to surgical resection or transplantation allowed
- •Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) ≥ 10 mm by contrasted CT scan
- •No equivocal, nonmeasurable, or nonevaluable liver cancer
- •No more than 75% replacement of normal liver by tumor
- •Cancer of the Liver Italian Program (CLIP) stage 1-3 disease
- •No extra-hepatic metastases as determined by CT scan or MRI
排除标准
- •Life expectancy ≥ 3 months
- •Karnofsky performance status 50-100%
- •Creatinine ≤ 1.5 mg/dL
- •Bilirubin ≤ 2.0 mg/dL
- •Albumin ≥ 3 g/dL
- •Granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 65,000/mm³
- •INR ≤ 1.4
- •Hemoglobin > 9 g/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No nonmalignant disease that would render the patient ineligible for treatment according to this protocol
- •No hepatic arterial anatomy that would prevent the administration of study drug into the liver
- •Less than 20% arteriovenous lung shunting on a technetium 99m-labeled macroaggregated albumin nuclear scan
- •No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 90 days since prior surgery, chemotherapy, or locally ablative technique for the liver cancer
- •More than 4 weeks since prior and no other concurrent investigational drug or agent/procedure (i.e., participation in another trial)
- •No prior radiotherapy to the upper abdomen that included the liver in the treatment field
- •No capecitabine within 8 weeks before or after study treatment
- •No other anticancer treatment (except surgical resection) for liver cancer during and for 3 months after completion of study treatment
结局指标
主要结局
Tumor response
时间窗: up to 12 months
All uni-dimensional measurable lesions (longest diameter \>20mm with conventional techniques and \>10mm with spiral CT scans) up to a maximum of five lesions per organ with a maximum of 10 lesions in total are used to determine response.
次要结局
- Toxicity(up to 3 months)
- Health-related quality of life(prior to initial treatment.)
- Survival(trial entry to death)
研究者
Steven Meranze, MD
Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist
Vanderbilt-Ingram Cancer Center
研究点 (2)
Loading locations...
相似试验
终止
2 期
Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine TumorsHead and Neck CancerIslet Cell TumorMetastatic CancerPheochromocytomaNCT00466856Vanderbilt-Ingram Cancer Center10
撤回
2 期
Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by SurgeryLiver CancerNCT00039078Allan Tsung
Unknown
1 期
Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain TumorMetastatic CancerNCT00107367The Cleveland Clinic62
已完成
不适用
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or PineoblastomaBrain and Central Nervous System TumorsLong-term Effects Secondary to Cancer Therapy in ChildrenNCT00105560Massachusetts General Hospital59
已完成
不适用
CIRSE Registry for SIR-Spheres in France (CIRT-FR)Liver CancerNCT03256994Cardiovascular and Interventional Radiological Society of Europe332