Randomized Prospective Two-Arm Feasibility Trial of Stereotactic Body Radiation Therapy Versus Yttrium-90 Segmentectomy in Inoperable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Feasibility of enrollment (enrollment rate)
研究概览
简要总结
This phase II trial tests whether Y-90 segmentectomy (internal radiation) versus stereotactic body radiation therapy (external radiation) is more optimal in treating inoperable liver cancer. Y-90 segmentectomy consists into very tiny radioactive glass beads that can be injected into the liver through the blood vessels supplying the liver. Stereotactic body radiation therapy uses special equipment to position a patient and deliver external radiation to tumors with high precision. This study many help doctors determine which treatment, Y-90 segmentectomy or SBRT, works better in treating liver cancer.
详细描述
PRIMARY OBJECTIVE:
I. Determine feasibility of trial enrollment (enrollment date).
SECONDARY OBJECTIVE:
I. To assess differences in overall survival, local control, time to intrahepatic progression, time to next treatment, rate of liver transplant, toxicity, and patient reported complications and quality of life.
EXPLORATORY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
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.
- •Age >= 18 years at time of informed consent. Both men and women and members of all races and ethnic groups will be included.
- •Patient with non-metastatic hepatocellular carcinoma (HCC) including lesion(s) amenable to definitive therapy with either SBRT or Y-90 segmentectomy, limited to =< 2 liver segments, as agreed upon by the multidisciplinary tumor board consensus.
- •Patient not otherwise optimal candidates for resection or thermal ablation, as agreed upon by the multidisciplinary tumor board.
- •Have a Child-Pugh criteria (CP) score B7 or better.
- •Eastern Clinical Oncology Group (ECOG) performance status =< 1, or Karnofsky performance scale >
- •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
- •Participant is pregnant or breastfeeding, or expecting to conceive 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, unstable angina pectoris, cardiac arrhythmia, serious 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.
结局指标
主要结局
Feasibility of enrollment (enrollment rate)
时间窗: Up to 4 years
Determine feasibility of trial enrollment for two therapeutic groups.
次要结局
- Overall survival(Death, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, lost to follow up, or 13 months post-treatment)
- Rate of patient reported outcome-Common Terminology Criteria for Adverse Events(Baseline up to 13 months)
- Time to next treatment(Time to next liver directed or non-adjuvant systemic therapy, transplant, or death, assessed up to 13 months)
- Rate of liver transplant(Time of liver transplant, death, or 13 months post-treatment)
- Time to progression(Time of radiographic evidence of treated tumor progression as determined by tumor board review, adjuvant systemic therapy or liver directed therapy to treated lesion, transplant, death, or 13 months post-treatment)
- Time to intrahepatic progression(Time of radiographic intrahepatic progression, adjuvant systemic therapy or liver directed therapy, transplant, death, or 13 months post-treatment)
- Rate of non-classic radiation induced liver disease(Up to 13 months)
- Change in patient reported quality of life(Baseline to 13 months)
研究者
Nima Nabavizadeh
Principal Investigator
OHSU Knight Cancer Institute