Phase I-II Trial of Stereotactic Body Proton Therapy for Patients With Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Phase I of study: Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
Local control of hepatic metastases appears to be a major determinant of overall survival. However, many patients are not suitable for resection due to medical or surgical reasons. Therefore, there is an important role for a treatment that can provide the equivalent of tumor resection with minimal morbidity. Stereotactic body radiotherapy (SBRT) delivers an ablative regimen of highly focused external beam radiotherapy that targets one or more discrete extracranial lesions. Published reports using SBRT to treat liver metastases have shown actuarial local control rates ranging from 50-100% with higher doses associated with better local control.
In patients with metastatic liver disease, aggressive local therapy using modern radiotherapy techniques are promising and project to have a substantial role in the treatment of metastatic liver cancer to treat unresectable disease. The dosimetric advantage of proton therapy may lead to improved clinical outcomes with less morbidity, however, there is no clinical data to confirm this assertion. We thus propose a phase I study to determine the feasibility and safety of stereotactic body proton therapy in patients with liver metastases followed by a phase II study to determine the efficacy of such treatment on local control.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed non-lymphoma liver metastases or
- •New radiographic liver lesions consistent with metastases in patients with known pathologically confirmed non-lymphoma cancer
- •1-3 liver lesions measurable on CT/MRI or PET/CT performed within 6 weeks prior to study entry
- •Liver metastases measuring <5cm
- •Life expectancy >6 months
- •Disease outside the liver is allowed
- •ECOG Performance Scale = 0-1
- •Adequate bone marrow function, defined as follows:
- •Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 based upon CBC/differential obtained within 4 weeks prior to registration on study
- •Platelets ≥ 60,000 cell/mm3 based upon CBC/differential obtained within 4 weeks prior to registration on study
- •Hemoglobin ≥ 8.0 g/dl based upon CBC/differential obtained within 4 weeks prior to registration on study (Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 is acceptable.)
- •Adequate kidney function (serum creatinine <2mg/dL) based on chemistry panel obtained within 4 weeks prior to registration on study
- •Adequate liver function, defined as total bilirubin <5 mg/dL, serum albumin >2.0g/dL, serum levels of liver enzymes < 5 times the upper limit of normal, and INR < 1.5
- •Previous liver resection or ablative therapy is permitted
- •Chemotherapy and/or targeted agent therapy must be completed at least 2 weeks prior to radiation and started at least 14 days after completion of SBPT Women of childbearing potential and male participants must practice adequate contraception
- •Patient must sign study specific informed consent prior to study entry
- •Pretreatment evaluations required for eligibility include:
- •A complete history and general physical examination
- •For women of childbearing potential, a serum or urine pregnancy test must be performed within 72 hours prior to registration
- •INR, total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to study entry
排除标准
- •Prior invasive malignancy other than liver met primary (except non-melanomatous skin cancer) unless disease free for > 3years
- •Prior radiotherapy that would results in overlap of radiation fields
- •Prior radiotherapy to the liver
- •Severe, active co-morbidity that may impact survival
- •CNS metastases
- •Tense ascites requiring frequent paracentesis
- •Active liver infection
- •Pregnancy, nursing women, or women of child bearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- •Metastases location within 2cm of GI tract
研究组 & 干预措施
Proton Radiation
干预措施: Proton (Radiation)
Proton Radiation
干预措施: Proton Radiation (Radiation)
结局指标
主要结局
Phase I of study: Number of participants with adverse events as a measure of safety and tolerability
时间窗: The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months
次要结局
- Phase II -local control within irradiated fields at 2 years(The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months)