Randomized Study of Adjuvant Radiotherapy After Curative Resection of Hepatocellular Carcinoma With Narrow Margin (≤1 cm)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Recurrence Free Survival,RFS
研究概览
简要总结
RAISE is a multicenter randomized controlled trial to assess the efficacy of adjuvant radiotherapy for controlling postsurgical recurrence in HCC patients with narrow margin (≤ 1 cm) after curative resection.
详细描述
RAISE trial will recruit 148 patients, and they will be randomized (1:1) to two groups (the surgery group and the surgery-radiotherapy group). Random assignment was stratified by the condition of MVI and tumor size. All patients in the surgery-radiotherapy group received Intensity Modulated Radiation Therapy (IMRT) within 1-3 months after surgical resection. The prescription dose was planned at 50 gray in 25 fractions over 5-6 weeks. The trial is to verify whether adjuvant radiotherapy prolongs recurrence-free survival in patients with a narrow resection margin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years.
- •HCC who underwent R0 resection with pathological confirmation.
- •The narrowest margin is less than or equal to 1 cm.
- •No residual tumors after surgery based on postoperative CT or MR images in 4-6 weeks.
- •Child-Pugh score 5-
- •Expected life expectancy ≥ 6 months.
- •Blood, liver, and kidney functions meet the following criteria: 1)Neutrophil counts ≥ 1.5×109/L; 2)Platelet counts ≥ 60×109/L; 3)Hemoglobin concentration ≥ 90g/L; 4)Serum albumin concentration ≥ 30g/L; 5)Bilirubin ≤ 1.5 × upper limit of normal; 6)AST and ALT < 3× ULN; 7)Extended prothrombin time not exceeding 3s of ULN; 8)Creatinine < 1.5× ULN.
排除标准
- •Preoperative imaging revealed tumor thrombus in the portal vein, hepatic vein, bile duct, or extrahepatic metastasis.
- •The number of tumors ≥
- •Pregnant or lactating women or subjects scheduled for contraceptive procedures within 2 years.
- •Patients with concomitant HIV or syphilis infection.
- •Patients with concurrent or other malignancies within 5 years before enrollment.
- •Patients receiving allogeneic organ transplantation.
- •Patients with severe dysfunction of the heart, kidneys or other organs.
- •Participated in clinical trials of other drugs within 12 months before enrollment.
结局指标
主要结局
Recurrence Free Survival,RFS
时间窗: two years
Defined as the time from randomization until disease recurrence or death from any cause, whichever happens first.
次要结局
- Time To Recurrence, TTR(two years)
- Incidence of Treatment-Emergent Adverse Events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).(two years)
- health related quality of life(two years)
- Overall Survival, OS(two years)
研究者
Ming Kuang
professor
Sun Yat-sen University