A Randomised Phase III Trial on Stereotactic Body Radiotherapy (SBRT) After Incomplete Transcatheter Arterial Embolization (TAE) or Chemoembolization (TACE) Versus Exclusive TAE or TACE for Inoperable Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)
研究概览
简要总结
The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.
详细描述
In this phase III study patients with inoperable HCC single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of TAE or TACE. A total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either SBRT or TAE/TACE. The follow-up period will be finished 1.5 years after the final patient is randomised.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Karnofsky index >70%
- •Child-Turgotte-Pugh A or B liver score.
- •An initial diagnosis of primary HCC or recurrence.
- •A technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
- •HCC (single nodule ≤ 5 cm or max 3 nodules ≤ 3 cm) diagnosed by histology or non-invasive EASL criteria
- •Baseline CT or MRI and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease
- •Hb >10.5.0 g/%, WBC >3.000 cells/mm3, platelets >50.000 cells/mm3, bilirubin <2 mg/dl, aspartate and alanine aminotransferase levels <5 times upper normal limit, and prothrombin time-international normalized ratio ≤ 2;
- •Serum creatinine <1.7 mg/dl
- •Previously incomplete TAE or TACE with radiologically defined residual disease.
- •Informed consent
排除标准
- •Extrahepatic disease and refractory ascites.
- •Previous abdominal radiation therapy (RT)
- •Hemorrhage/bleeding event = Grade 3 within 4 weeks of enrollment in the study.
- •Pregnant or breastfeeding patients.
- •Patients with uncontrolled infections or HIV seropositive patients.
- •Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.
研究组 & 干预措施
Stereotactic body radiation therapy
HCC after incomplete TAE or TACE treated by SBRT
干预措施: SBRT (Radiation)
TACE/TAE
HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE
干预措施: TACE (Procedure)
结局指标
主要结局
Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)
时间窗: 1.5 years
This is a study designed to evaluate the efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE.
次要结局
- overall survival(1.5 years)
- toxicity (incidence of acute and late complications)(1.5 years)
- progression free-survival(1.5 years)