临床试验/NCT01360606

NCT01360606已完成不适用

A Phase I Study of Stereotactic Body Radiation Therapy (SBRT) for Liver Metastases

Susannah Ellsworth1 个研究点分布在 1 个国家目标入组 9 人开始时间: 2012年3月23日最近更新: 2024年10月10日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 9
试验地点: 1
主要终点: Maximum Tolerated Dose (MTD)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a phase I dose escalation study. Dose escalation will be via the traditional "up and down" scheme. SBRT:

Patients will receive one of the following radiation regimens:

50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.
60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period.

详细描述

Prior to enrollment all patients will be evaluated with a physical exam, review of pathology and laboratory values to confirm diagnosis, and baseline imaging studies.

Accelerator

Physicians will treat with a stereotactic radiosurgery system using 6MV photons to deliver stereotactic body radiotherapy.

Doses

Patients will receive a total dose ranging from 50-75 Gy in 5 fractions (10-15 Gy/fx). Dose escalation will be via the traditional "up and down" scheme.

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

•Male or female patients ≥ 18 years of age
•A life expectancy of at least 6 months with a Karnofsky performance status of at least 70
•The target lesion(s) can be accurately measured in at least one dimension according to RECIST and must have a maximum tumor volume of ≤ 100 cm3
•No prior radiotherapy to the upper abdomen
•Previous systemic chemotherapy or non-radiation local therapy (such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) is allowed. The lesion must however have shown criteria of progression based on RECIST. Local therapy must be completed at least 4 weeks prior to the baseline scan. This is to create a safer treatment environment and to help determine the effect of treatment by SBRT alone. Patients will be allowed to go onto appropriate systemic therapy, as determined by their medical oncologist, 2 weeks following delivery of SBRT
•Patients with resectable disease will be eligible for participation if they have comorbidities precluding surgery or refuse to undergo an operation
•Cirrhotic status of Child-Pugh class A or B
•Patients can have extra-hepatic disease, provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with surgery, ablative radiation therapy, or US Food and Drug Administration-approved first- or second-line systemic therapy regimens
•Patient's will have no evidence of gross vascular invasion.
•Patients will have no more than 3 distinct lesions, all being ≤ 3cm in greatest dimension, OR 1 lesion ≤ 6cm in greatest dimension
•Platelet count ≥ 60 x 109/L, Hemoglobin ≥ 8.5 g/dL, WBC ≥ 2000/μL International normalized ratio (INR) must be ≤ 2.
•Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists
•Other baseline labs must meet the following criteria: total bilirubin < 3mg/dl, albumin> 2.5mg/dl, and liver enzymes less than three times the upper limit of normal. Creatinine must also be < 1.8mg/dl or a creatinine clearance > 50ml/min
•Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts

排除标准

•Renal failure requiring hemo- or peritoneal dialysis
•Uncontrolled inter-current illness including, but not limited to ongoing or active infection (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 4.0), congestive heart failure (> New York Heart Association (NYHA) class 2), active coronary artery disease (CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), uncontrolled hypertension and any condition which could jeopardize the safety of the patient and his/her compliance in the study . Myocardial infarction more than 6 months prior to study entry is permitted
•A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
•History of an active connective tissue disorder
•Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
•Pregnant or breast-feeding patients are excluded from this study because abdominal radiation therapy has potential for teratogenic and/or abortifacient effects
•Portal vein occlusion
•Extensive liver tumor burden, defined as more than 75% of the liver.
•Patients with primary tumor histology of lymphoma, leukemia, or germ cell tumor
•Patients with hepatocellular carcinoma will be excluded from this study

研究组 & 干预措施

SBRT

Other

干预措施: Stereotactic Body Radiation Therapy (Radiation)

结局指标

主要结局

Maximum Tolerated Dose (MTD)

时间窗: Up to 16 Months

MTD as determined by dose limiting toxicities (DLT), defined as any grade III stomach, bowel, liver, or spinal cord toxicity, or any grade IV toxicity per RTOG criteria. Only toxicities observed prior to 7 months after the last fraction of radiation were considered. The MTD is the highest dose level at which no more than 1 of 6 treated patients experiences a DLT.

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

时间窗: Up to 16 Months

Dose limiting toxicity (DLT) will be defined as any grade III stomach, bowel, liver, or spinal cord toxicity, or any grade IV toxicity as defined by the Radiation Therapy Oncology Group (RTOG).

次要结局

Local Control(Up to 6 years and 4 months (study population))
Local Response Rate(Up to 6 years and 4 months (study population))
FACT-G - Health Related Quality of Life (HRQL) Over Time(1-2 months, 3-5 months, 6-8 months, 9-11 months,12-14 months,15-17 months, 18-20 months, 21-23 months, 24-26 months)
Functional Assessment of Cancer Therapy-Hepatobiliary Index (FSHI) Over Time(1-2 months, 3-5 months, 6-8 months, 9-11 months,12-14 months,15-17 months, 18-20 months, 21-23 months, 24-26 months)
FACT-Hep-Trial Outcome Index (TOI)(1-2 months, 3-5 months, 6-8 months, 9-11 months,12-14 months,15-17 months, 18-20 months, 21-23 months, 24-26 months)

研究者

发起方

Susannah Ellsworth

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Susannah Ellsworth

Clinical Associate Professor

University of Pittsburgh

研究点 (1)

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