NCT03812289终止不适用
A Pilot Study to Assess Feasibility of Hypofractionation and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT
研究概览
简要总结
This trial studies how well stereotactic body radiation therapy works in treating patients with liver cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVE:
I. Assess the use of stereotactic body radiation therapy (SBRT) in hepatocellular carcinoma (HCC) patients with advanced liver cirrhosis as a feasible approach to providing localized disease control that adequately suffices liver transplant eligibility criteria.
SECONDARY OBJECTIVE:
I. Assess preliminary efficacy and toxicity in HCC patients with advanced cirrhosis following liver SBRT.
EXPLORATORY OBJECTIVE:
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
- •Ability to understand and the willingness to sign a written informed consent document
- •Must be listed or recommended to be listed for orthotopic liver transplantation at the participating institution
- •Have a Child-Pugh (CP) score >= B8
- •Eastern Clinical Oncology Group (ECOG) performance status =< 2, or Karnofsky performance scale > 60
- •Must have a life expectancy > 12 weeks
- •Safe radiation treatment planning parameters that adhere to all organs at risk constraints per section 5.1 of the protocol. If normal organs at risk constraints (including at least 700cc of uninvolved liver) are unable to be met at the lowest dose modification (30 Gy in 5 fractions), the patient is deemed ineligible for SBRT and deemed a screen failure
- •Except for prior radiotherapy or radioembolization, other prior therapies to previously treated lesions, are permitted
- •People of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of SBRT. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year without an alternative medical cause
- •Note: Abstinence is acceptable if this is the preferred contraception for the participant
- •No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years
排除标准
- •Participants have any one of the following liver tumor characteristics:
- •Have > 5 liver tumors, or
- •Maximal diameter > 5 cm
- •Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
- •Prior radiotherapy to the upper abdomen or radioembolization of the liver, or prior thermal ablation to the target lesion
- •For fiducial marker placement:
- •Have a gold allergy
- •Any coagulopathy preventing safe fiducial placement
- •Contraindication to both contrast enhanced magnetic resonance imaging (MRI) and contrast enhanced computed tomography (CT) (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
- •Participation in another concurrent treatment protocol
- •Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
- •Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
研究组 & 干预措施
Treatment (SBRT)
Experimental
Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Treatment (SBRT)
Experimental
Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Treatment (SBRT)
Experimental
Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT
时间窗: From first SBRT dose to time of disease progression, transplantation, or 1 year after last SBRT dose (Day 374), whichever occurs first
"Transplant eligible" means transplanted within 1 year or having localized disease control that meets Milan criteria at 1-year post-SBRT. Reported with 95% exact confidence interval.
次要结局
- Incidence of Extrahepatic Progressive Disease(From first dose of SBRT to time of extrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.)
- Localized Control Rate(From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first)
- Incidence of Intrahepatic Progressive Disease(From first SBRT dose to time of intrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.)
- Overall Survival(From first SBRT dose to time of death or 2 years after last SBRT dose (Day 739), whichever occurs first.)
- Incidence of Non-classic Radiation-induced Liver Disease (RILD)(From first SBRT dose to 3 months after last SBRT dose (Day 100))
- Proportion of Participants That Proceed to Transplantation(From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.)
- Incidence of Liver Toxicity Within 1 Week to 3 Months After SBRT.(From 1 week (Day 16) to 3 months (Day 100) after completing SBRT)
研究者
Nima Nabavizadeh
Principal Investigator
OHSU Knight Cancer Institute
研究点 (2)
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