A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Percentage of Patients With Change in Child Pugh Score >= 2
研究概览
简要总结
This is a pilot single arm study with the primary endpoints of feasibility and preliminary estimates of safety and efficacy. This protocol builds on over 25 years of experience with high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the global radiation dose based on a patient's measured sensitivity to treatment. This current protocol uses functional imaging and specialized radiation planning techniques to spare highly functional portions of the liver to preserve function. The investigators feel this will further improve the safety and efficacy of RT for all patients by customizing treatments to each. If this approach is promising, the investigators will proceed to a phase II randomized study of standard versus spatially and dosimetrically adapted RT.
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
- •Patients must have hepatocellular carcinoma.
- •Patients must not have extrahepatic cancer.
- •Patients must not be eligible for a curative liver resection or have refused resection
- •Patients must have recovered from the acute effects of prior liver-directed therapy and 4 weeks must have passed since the last procedure and protocol therapy.
- •Patients must have a Zubrod performance status of less than or equal to 2 (Zubrod performance status is a measure that attempts to quantify a cancer patients' general well-being. Scores run from 0 to 5 where 0 denotes normal activity and 5 denotes death).
- •Patients must be 18 years of age or older.
- •Patients must have adequate organ function.
- •Patients must understand and be willing to sign an IRB (Institutional Review Board) approved informed consent form.
排除标准
- •Patients with known allergies to intravenous iodinated contrast agents.
- •Patients with a contraindication to contrast-enhanced MRI are excluded.
结局指标
主要结局
Percentage of Patients With Change in Child Pugh Score >= 2
时间窗: Baseline to approximately 6 months after initiation of SBRT
Rate of liver decompensation reported as the percentage of patients with a change in Child Pugh score of greater than or equal to 2 within 6 months of SBRT.
Median Time to Local Progression
时间窗: 24 months
The primary efficacy endpoint is local control, measured as the duration of time from start of treatment to time of progression of the treated (target) lesion(s). Patients with no evidence of local progression at the time of data analysis will be censored at the last date on which they were evaluated for local progression. Local progression will be summarized with Kaplan-Meier curves and reported with 95% confidence intervals.
The Proportion of Patients for Whom the Intended Treatment Was Feasible
时间窗: At end of treatment; up to ~3 months
The primary aim of the trial is feasibility which is defined as the ability to successfully deliver the full treatment including all adaptations and in particular the perfusion-based planning and replanning.
次要结局
- Overall Survival(24 months)
- Median Time to Progression(24 months)
- Incidence of Grade 3 Gastrointestinal (GI) Bleeding Toxicities(Approximately 6 months)
- Change in ALBI Scores(Approximately 6 months)