Phase II Randomized Trial Comparing Percutaneous Ablation to Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients (PROVE-HCC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Quality of Life (QOL) Using EORTC C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)
研究概览
简要总结
This phase II, randomized trial compare Quality of Life for patients with Hepatocellular Carcinoma (HCC) who are not surgical candidates or decline surgery and are treated with Percutaneous Local Ablation (PLA) or Hypofractionated Image-Guided Radiation Therapy (HIGRT).
详细描述
Administrative clarification:
This clinical trial was terminated due to poor enrollment and was replaced by a separate non-randomized trial (NCT04933435).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria) by CT or MRI
- •Patient is 18 years or older
- •ECOG Performance status of 0-2
- •Child Pugh score A5, A6, B7 or B8
- •Lesions less than or equal to 5cm in size
- •Less than or equal to 3 lesions in the liver to be treated on protocol
- •Lesion amenable to treatment with both PLA and HIGRT; for PLA treatment this requires the lesion be visible via ultrasound and/or non-contrast CT or feasible per treating physician
排除标准
- •Child Pugh score B9 or Class C
- •Fluctuating ascites
- •Inability to complete baseline QOL forms
- •Concurrent administration of systemic therapy for HCC
- •Prior liver RT is an exclusion unless subject participation is approved by the PI
- •Positive serum pregnancy test
研究组 & 干预措施
Percutaneous Local Ablation (PLA)
A PLA procedure uses high-energy radio waves to treat liver tumors. Using CT and ultrasound guidance the doctor inserts a thin, needle-like probe into the liver tumor A high-frequency current is then passed through the tip of the probe, which heats the tumor with the goal to destroy the cancer cells. This may be done as an outpatient procedure or a short (1-2 day) hospital stay. PLA is the standard treatment for patients with liver cancer who cannot undergo liver surgery.
干预措施: Percutaneous Local Ablation (Procedure)
Hypofractionated Image-Guided Radiation Therapy (HIGRT)
HIGRT is an emerging treatment option for patients with HCC; it utilizes external radiation where multiple beams enter the body from multiple angles to treat the liver cancer over typically 5-10 treatments while minimizing radiation to normal tissues. You will receive between 5-10 fractions (treatments) of radiation. Fraction size will be either 5 or 10 Gy (pronounced Gray, a standard unit of radiation measurement) depending on your tumor size and location or underlying liver function. The total dose of radiation is 50 Gy.
干预措施: Hypofractionated Image Guided Radiation Therapy (Radiation)
结局指标
主要结局
Change in Quality of Life (QOL) Using EORTC C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)
时间窗: Baseline to one month
To compare change in Quality of Life (QOL), as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) post treatment in patients receiving PLA vs HIGRT. The EORTC QLQ-C30 reports a Summary Score that is calculated from the mean of 13 of the 15 QLQ-C30 scales (excluding Global Quality of Life scale and the Financial Impact scale). 28 of the items have a range of 1 (not at all) to 4 (very much) and two of them have a range of 1 (very poor) to 7 (excellent). The total summary score ranges from 30 to 126, with lower scores indicating a better quality of life. Only the change in summary score is reported; no individual subscale scores are reported.
次要结局
- Change in Quality of Life (QOL) Using The Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Assessment(Baseline, 1 month, 3 months; change between baseline and 3 months reported)
- Change in Quality of Life (QOL) Using EORTC QLQ C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)(Baseline to 6 months)
- Number of Participants With Grade 2 or Higher Adverse Events(Up to 90 days post treatment)
- The Total Healthcare System Costs Associated With PLA vs HIGRT(From time of intervention to 90 days post treatment)
- Change in Quality of Life (QOL) Using EORTC QLQ C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)(Baseline to 3 months)