A Randomized Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) With DEBDOX Beads as a Bridge to Transplant in Hepatocellular Carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Lahey Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Freedom From Progression Over Time
研究概览
简要总结
This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to orthotopic liver transplantation.
详细描述
For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to orthotopic liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Stereotactic Body Radiation Therapy (SBRT)
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Arm B
Trans-Arterial Chemoembolization (TACE) Drug: Doxorubin
干预措施: Trans-Arterial Chemoembolization (TACE) (Procedure)
Arm B
Trans-Arterial Chemoembolization (TACE) Drug: Doxorubin
干预措施: Doxorubin (Drug)
结局指标
主要结局
Freedom From Progression Over Time
时间窗: 3, 6 and 12 Months
Time from SBRT and TACE intervention to progression was tracked for subject receiving protocol intervention. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.
次要结局
- Toxicity To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE(At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment)
- Number of Participants Who Require Further Interventions Prior to Liver Transplant(2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment)
- Pathologic Response of Treated Lesion(s)(At time of liver transplant)
- Radiologic Response of Treat Lesion(s)(Baseline, 3 months post-treatment, 6 months post-treatment, every 3 months thereafter until 2 years post treatment)
- Quality of Life - Questionnaires Include PIQ-6 and SF-36v2 Health Survey(Baseline, 2 weeks post-treatment, 6 months post-treatment)