Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 8
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether surgery and hepatic arterial chemotherapy are more effective than surgery alone in treating patients with liver cancer that has spread to the portal vein.
PURPOSE: This randomized phase III trial is studying surgery and hepatic arterial chemotherapy to see how well they work compared to surgery alone in treating patients with liver cancer that has spread to the portal vein.
详细描述
OBJECTIVES:
- Compare the efficacy of surgical resection with vs without postoperative hepatic arterial chemotherapy in patients with hepatocellular carcinoma and portal vein tumor thrombus.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to grade of portal invasion and Child-Pugh classification. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo macroscopic curative resection. Within 28 days after surgery, patients without post-surgery complications undergo hepatic arterial infusion comprising fluorouracil and cisplatin on days 1-5, 8-12, and 15-19. Treatment continues for 6 months.
- Arm II: Patients undergo macroscopic curative resection.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed hepatocellular carcinoma (HCC) with portal vein tumor thrombus
- •Tumor thrombus in the main trunk or first branch of the portal vein
- •No apparent distant metastases on chest CT scan and bone scintigraphy within the past 6 weeks
- •No pleural effusion or ascites
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Neutrophil count > 1,000/mm^3
- •Platelet count > 50,000/mm^3
- •Hemoglobin > 8 g/dL
- •Bilirubin < 2 times upper limit of normal (ULN)
- •ALT and AST < 4 times ULN
- •Creatinine normal
- •Cardiovascular
- •No severe heart disease
- •No cardiac effusion
- •No other malignant disease
- •No high risk for esophageal varices rupture
- •No allergy to fluorouracil or cisplatin
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior hepatic arterial chemotherapy
- •No prior systemic chemotherapy for HCC
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供