International Randomized Study of Transarterial Chemoembolization (TACE) Versus Stereotactic Body Radiotherapy (SBRT) / Stereotactic Ablative Radiotherapy (SABR) for Residual or Recurrent Hepatocellular Carcinoma After Initial TACE
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Number of Participants With a Local Progression Event
研究概览
简要总结
This randomized phase III trial studies how well transarterial chemoembolization (TACE) works compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation therapy (SABR) in patients with liver cancer that remain after attempts to remove the cancer have been made (residual) or has come back (recurrent). TACE is a minimally invasive, image-guided treatment procedure that uses a catheter to deliver both chemotherapy medication and embolization materials into the blood vessels that lead to the tumors. SBRT or SABR may be able to send radiation directly to the tumor and cause less damage to normal liver tissue. It is not yet known whether TACE is more effective than SBRT or SABR in treating patients with persistent or recurrent liver cancer who have undergone initial TACE.
详细描述
PRIMARY OBJECTIVES:
I. To determine the freedom from local progression (FFLP) of TACE versus (vs) SABR in patients with persistent hepatocellular carcinoma (HCC) after TACE.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival (PFS) of TACE vs SABR in patients with persistent HCC after initial TACE.
II. To determine the overall survival (OS) of TACE vs SABR for persistent HCC. III. To determine the toxicities associated with TACE or SABR for persistent HCC.
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
- •Confirmed hepatocellular carcinoma (HCC) by one of the following:
- •Histopathology
- •One radiographic technique that confirms a lesion >= 1 cm with arterial hypervascularization with washout on delayed phase
- •Radiographic evidence of persistent, progressive, or recurrent disease in an area previously treated with TACE and determined from 3 months after initial TACE; this evaluation should be within 6 weeks of date of study eligibility
- •Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension; multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 10 cm as long as the dose constraints to normal tissue can be met
- •Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2
- •Patients with liver disease classified as Child Pugh class A or B, with score =< 9 ((within 4 weeks of treatment)
- •Life expectancy >= 6 months
- •Ability of the research subject or authorized legal representative to understand and have the willingness to sign a written informed consent document
排除标准
- •Prior radiotherapy to the upper abdomen
- •Prior radioembolization to the liver
- •Prior radiofrequency ablation (RFA) to index lesion
- •Liver transplant
- •Active gastrointestinal bleed within 2 weeks of study enrollment
- •Ascites refractory to medical therapy (mild to moderate ascites is allowed)
- •Women who are pregnant or breastfeeding
- •Administration of chemotherapy within the last 1 month
- •Extrahepatic metastases
- •Participation in another concurrent treatment protocol
- •Prior history of malignancy other than HCC, dermatologic basal cell or squamous cell carcinoma
研究组 & 干预措施
Arm I (TACE)
Patients undergo TACE.
干预措施: Transarterial Chemoembolization (Procedure)
Arm I (TACE)
Patients undergo TACE.
干预措施: embolic agent (Drug)
Arm I (TACE)
Patients undergo TACE.
干预措施: lipiodol (Drug)
Arm II (SBRT)
Beginning within 2 weeks of the radiation set-up scan and within 4 weeks of fiducial seed implantation (if applicable), patients undergo image guided SBRT 3 fractions within 1 week or 5 fractions within 2 weeks.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Number of Participants With a Local Progression Event
时间窗: Up to 12 months
Local progression event: occurring in the treated hepatic lesion.
次要结局
- The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Freedom From Local Progression (FFLP)(Up to 18 months)
- The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Progression-free Survival (PFS)(Up to 18 months)
- The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Overall Survival (OS)(Up to 18 months)
- Comparison of Median Freedom From Extra Hepatic Progression(Up to 16 weeks)
- The Impact of Elevated Serum Alpha-Fetoprotein Level (AFP) on Extra Hepatic PFS(Up to 18 months)
- Median OS(Time from randomization until death from any cause, assessed up to 3 years)
- Median Extra Hepatic PFS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group(At 18 months)
- Median FFLP for Patients With Tumors Smaller Than 3 cm and With Tumors Greater Than 3 cm Per Treatment Group(At 18 months)
- Median OS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group(At 18 months)
- Number of Participants With Disease Progression or Death(Randomization through 3 years)
- Number of Participants With Disease Progression or Death by Tumor Size (<= 3 cm and > 3 cm) Per Treatment Group(Randomization through 18 months)
研究者
Erqi Liu Pollom
Associate Professor of Radiation Oncology (Radiation Therapy)
Stanford University