Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Number of Patients With DLTs
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of limited fractions of large dose radiation in an effort to achieve a biologically potent cancer therapy in selected patients with primary hepatocellular carcinoma.
详细描述
Despite recent advances in early detection and diagnosis, only 30-40% of patients with hepatocellular carcinoma may benefit from radical therapies. Liver transplantation offers the best chance for cure. Surgical resection has been the only other potentially curative option, but the majority of patients are not candidates for resection. This reflects the usual comorbidity of severe underlying liver disease that either precludes surgery or makes the surgical approach extremely dangerous.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Evaluation by the Surgery and/or Liver Transplant Team has been performed and the patient is not considered a candidate for either "standard" therapy to target area (upper abdomen)
- •Adequate liver function defined as:
- •total bilirubin < 3mg/dl, albumin > 2.5 g/dl
- •normal PT/PTT unless on anticoagulants
- •mild elevation of liver enzymes acceptable (must be less than three times upper limit of normal)
- •Adequate renal function (creatinine < 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)
- •Adequate bone marrow reserve:
- •ANC count ≥ 1500 mm3
- •Platelets ≥ 50,000/mm3
- •Hemoglobin > 9 g/dL
- •NOTE: Lab values must be obtained within 2 weeks prior to being registered for protocol therapy.
排除标准
- •No history of systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis or scleroderma
- •No chemotherapy within 14 days before radiotherapy (chemotherapy may cause transient hepatitis with hepatomegaly)
- •No subsequent chemotherapy planned within 2 weeks of radiotherapy
- •No active liver infection
- •No acute Hepatitis. Definition of active disease:
- •Hepatitis A: Acute hepatitis determined by presence of Anti-HAV- IgM
- •Hepatitis B:
- •HBsAg (HB surface Antigen): present in patients with acute and chronic hepatitis
- •HBV DNA present in patients with active viral replication in amounts greater than 100,000 copies
- •HBeAg is present in wild type HBV infection and suggests active replication
- •Anti-HBs: Antibody against HBsAg appears after HBV infections and confers immunity
- •Anti-HBc-IgM: Antibody against HBcAg, fraction IgM, present in acute infection and often could be detected during periods of high viral replication in chronic disease
- •Anti-HBc-IgG: is present in chronic disease
研究组 & 干预措施
Radiation Treatment Arm :A
Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days
干预措施: Stereotactic Body Radiation (Radiation)
Radiation Treatment Arm: B
Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks.
干预措施: Stereotactic Body Radiation (Radiation)
结局指标
主要结局
Number of Patients With DLTs
时间窗: 6 weeks
Number of patients experiencing a Dose Limiting Toxicity during the Phase I portion of the trial.
6 Month Local In-field Control
时间窗: 6 months
Percent of patients and the 95% Binomial Confidence interval who were free of in-field progression at 6 months following treatment for the patients in Phase II
次要结局
- Overall Survival(Up to 8 years)
- Time to In-field Failure(up to 4 yrs)
- Phase II: Number of Patients With Treatment Related Grade 3 or 4 Adverse Events(up to 4 years)
研究者
Mark Langer
Professor of Clinical Radiation Oncology
Indiana University School of Medicine