A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.
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/II trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.
详细描述
OUTLINE: This is a phase I/II, dose-escalation study.
Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation (any histology except lymphoma, leukemia, or hepatocellular carcinoma) of at least one liver lesion that is synchronous to the primary diagnosis of malignancy or metachronous as a recurrence/metastasis or as a failure following previous therapy (except radiotherapy).
- •One to three metastatic liver lesions =< 5 cm in dimension.
- •Intrahepatic cholangiocarcinoma is acceptable for inclusion.
- •Zubrod Performance Status (PS) 0 or
- •Please contact study investigator and/or consult protocol document for specific details on laboratory criteria.
- •Life expectancy >= 12 weeks.
- •MELD (Model for End-Stage Liver Disease) score =<
- •>= 1000 cc of uninvolved liver parenchyma as determined by the treating physician.
- •Determination that the patient is medically inoperable and/or unwilling to undergo liver resection in patients with colorectal carcinoma histology.
- •Provide informed written consent.
- •Willingness to return to Mayo Clinic Rochester for follow-up.
排除标准
- •Pregnant women.
- •Nursing women.
- •Men or women of childbearing potential or their partners who are unwilling to employ adequate contraception.
- •Co-morbid systemic illnesses or other severe concurrent disease, defined as those which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 7 days prior to registration.
- •Administration of chemotherapy within 2 wks prior to or 2 wks following SF-SBRT.
- •Prior radiation therapy to the liver Untreated malignant biliary obstruction (patients treated successfully with stenting are eligible).
- •Current diagnosis of hepatocellular carcinoma
研究组 & 干预措施
Arm I
Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
干预措施: stereotactic radiation therapy (Radiation)
Arm I
Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
干预措施: implanted fiducial-based imaging (Procedure)
Arm I
Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
干预措施: cone-beam computed tomography (Procedure)
结局指标
主要结局
Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.
时间窗: 2 months
Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)
时间窗: At 1 year
LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.
次要结局
- Local Control (LC) Cumulative Incidence Rates (Phase II)(3 and 6 months and 1, 2, and 5 years)
- Toxicity and Adverse Events Profile (Phase I)(Up to 2 years)
- Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)(Up to 2 years)
- Radiographic Response Rate (Phase II)(Up to 2 years)
- Median Time to Progression of Treated Tumors (Phase II)(Up to 5 years)
- Refinement of Toxicity and Adverse Events Profile (Phase II)(Up to 2 years)
- Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)(Up to 2 years)
- Evaluation of Cause of Death (Phase II)(Up to 5 years)