Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 1-year Overall Survival (OS)
研究概览
简要总结
Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers
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
- •Histologically confirmed HCC, intrahepatic cholangiocarcinoma, or metastatic cancer. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases (lesion > 1 cm with arterial phase hyperenhancement and venous phase washout) or LI-RADS score of 5 may be used
- •≥ 18 years old at time of study enrollment
- •Child-Pugh A status
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- •Life Expectancy > 6 months
- •For women of childbearing potential or who are not postmenopausal (see Appendix F for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done.
- •Ability to understand and the willingness to provide written informed consent.
- •Patients treated with prior liver-directed therapies with the exception of radioembolization are eligible for this study if they otherwise meet eligibility criteria
排除标准
- •Prior treatment with radioembolization
- •Cytotoxic chemotherapy or investigational agent within 1 week of SABR
- •Prior radiotherapy overlapping with study treatment site
- •Female patients who are pregnant
- •Contraindication to having an MRI scan or inability to tolerate MRI
- •Presence of a pacemaker or other implanted cardiac device
- •Direct tumor extension into the stomach, duodenum, small bowel or large bowel
- •Patient unable to breath hold > 15 seconds
研究组 & 干预措施
MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR)
Participants will receive a single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) using the MRIdian system. Treatment includes daily adaptive planning based on MRI to optimize dose delivery to the tumor and minimize dose to surrounding normal tissue. Eovist contrast is administered before treatment to enhance visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion.
干预措施: MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) (Radiation)
结局指标
主要结局
1-year Overall Survival (OS)
时间窗: 1 year after SABR
Overall survival will be defined as the time from treatment to death from any cause. Patients alive at the time of analysis will be censored at last follow-up.
次要结局
- Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events(Within 90 days of completing SABR)
- Rate of Grade ≥ 2 Radiation Pneumonitis(Within 90 days of completing SABR)
- Rate of Grade ≥ 2 Chest Wall Toxicity(Within 90 days of completing SABR)
- Change from Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score up to 1 Year Post-SABR(Up to 1 year post-SABR)
- Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR(Up to 1 year post-SABR)
- Change from Baseline in COST-FACIT Total Score up to 1 Year Post-SABR(Up to 1 year post-SABR)
- Rate of Patients With Total Delivery Time > 120 Minutes(Baseline)