RAD 0902: A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Safety of a Combination Therapy
研究概览
简要总结
This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.
详细描述
Primary objectives of this research
- Evaluate the safety of a combination of TACE and high dose SBRT
- Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE & SBRT.
Secondary objectives of this research
- Assess failure patterns and survival of patients treated with TACE & SBRT.
- Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting all the following criteria will be considered for enrollment:
- •Pathologically confirmed HCC -OR
- •HCC greater than 2 cm with classic radiographic findings on 2 separate testing modalities, or an HCC greater than 2 cm with a serum alpha feto-protein greater than
- •Single liver lesion: measuring 3 cm to ≤ 8 cm*.
- •Multiple liver lesions: ≤ 3 liver lesions, none measuring over 5 cm, provided all lesions are considered for TACE.
- •Lesions <3 cm if they are in an unfavorable location for ablation† *The size criteria of hepatic lesions are also subjected to the dose volume constraints for radiotherapy, as described below.
- •Patient deemed to not candidate or should have refused liver-transplant, surgery or RFA.
- •Patient must be a candidate and receive TACE.
- •ECOG (Eastern Cooperative Oncology Group) Zubrod Performance Scale = 0-
- •Age > 19
- •Patient should not be pregnant. Women of childbearing potential and male participants must practice adequate contraception.
- •Adequate hematological profile and adequate liver functions. Signed informed consent document
- •Imaging studies completed at least 60 days prior to study entry. Evaluated by radiation oncologist within 2 weeks prior to study entry.
排除标准
- •Patients presenting with any of the following will not be included in the study:
- •Prior invasive malignancies
- •Prior radiotherapy to the liver or surrounding areas.
- •Systemic therapy using any chemotherapy and/or targeted agents given within 2 weeks prior to TACE, during RT, and / or within 3 weeks following RT
- •Severe medical co-morbidities
- •INR (international normalized ratio) > 2 times upper level normal
- •Uncontrolled or symptomatic clinical ascites
- •Major surgical procedure within 3 weeks prior to study entry.
- •History of hypersensitivity to chemotherapy agents, contrast material.
- •Pregnancy, breast-feeding or planning to become pregnant.
- •Treatment with any investigational product in the last 4 weeks before study entry.
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Patients of Reproductive Potential The patient must not be pregnant or breast-feeding at enrollment in the study. Absence of pregnancy must be demonstrated by serum or urine testing prior to enrollment into the study.
- •Female patients of child bearing potential (i.e., ovulating, premenopausal, not surgical sterile) must use a medically accepted contraceptive regimen. Male patients must agree to use a medically approved method of contraception.
研究组 & 干预措施
Stereotactic Body Radiation Therapy (SBRT)
Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.)
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Combination Product)
结局指标
主要结局
Safety of a Combination Therapy
时间窗: Baseline to 45 day after completing combination treatment.
Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.
Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.
时间窗: Baseline to up to 2 years after treatment completed
Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.
Local Recurrence Rate
时间窗: Baseline to up to 2 years after treatment completed
Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.
次要结局
- Percentage of Participants With Overall Survival(up to 2 years after treatment completed)
- Percentage of Participants With Local Failure Patterns(Baseline up to 2 years after treatment completed)
研究者
Dr. Rojymon Jacob
Assistant Professor
University of Alabama at Birmingham