JPRN-jRCT1032180197招募中3 期
JCOG1315C: Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma - SPRING study
Akimoto Tetsuo0 个研究点目标入组 320 人开始时间: 2019年3月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1) single nodular hepatocellular carcinoma confirmed by dynamic contrast-enhanced CT or MRI of the liver within 28 days
- •2) cN0M0 diagnosed by dynamic contrast-enhanced CT or MRI of the upper abdomen and X ray or CT of the chest within 28 days
- •3) new-onset hepatocellular carcinoma
- •4) the maximum tumor diameter is larger than 3 cm and smaller than 12 cm
- •5) the margin of the tumor is at least 1 cm or more apart from the gastrointestinal tract (for patients in arm B: Proton beam therapy)
- •6) no invasion to or tumor thrombosis in the portal vein, the contralateral branches of the portal vein, or the first branch of the portal vein
- •7) no invasion to or tumor thrombosis in the inferior vena cava, the first branch of the hepatic vein, right inferior hepatic vein, or short hepatic vein
- •8) no invasion to or tumor thrombosis in the common bile duct or the first branch of the bile duct.
- •9) completely resectable by left lobectomy, anterior/posterior/lateral segmentectomy, extended subsegmentectomy, subsegmentectomy, or partial resection judged by the qualified surgeon and the conference including physicians of hepatobiliary and pancreatic surgery, hepatobiliary and pancreatic medicine, radiation oncology, and diagnostic radiology
- •10) No previous treatment for HCC
- •11) No ascites or hepatic encephalopathy
- •12) Age 20-85 years old
- •13) ECOG performance status of 0 or 1
- •14) Adequate organ functions
- •i) White blood cell (WBC) >= 2,000/mm3
- •ii) Platelet >= 50,000/mm3
- •iii) Hemoglobin >= 8.0 g/dl
- •iv) Total bilirubin < 2.0 mg/dl
- •v) Serum albumin > 3.5 g/dl
- •vi) Serum creatinine <= 1.5 mg/dl
- •vii) Prothrombin activity > 70%
- •15) Written informed consent
排除标准
- •1) synchronous or metachronous (within 5 years) malignancy
- •2) active infection requiring systemic therapy
- •3) body temperature >= 38 degrees Celsius
- •4) female during pregnancy, within 28 days of postparturition, or during lactation
- •5) severe psychological disorder
- •6) receiving continuous systemic corticosteroid or immunosuppressant treatment
- •7) poorly controlled diabetes mellitus
- •8) poorly controlled hypertension
- •9) unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
- •10) interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT
- •11) esophageal varices
研究者
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