JCOG1315C: Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma (SPRING study)
Active, not recruiting
- Conditions
- resectable hepatocellular carcinoma
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
- single nodular hepatocellular carcinoma confirmed by dynamic contrast-enhanced CT or MRI of the liver within 28 days
- cN0M0 diagnosed by dynamic contrast-enhanced CT or MRI of the upper abdomen and X ray or CT of the chest within 28 days
- new-onset hepatocellular carcinoma
- the maximum tumor diameter is larger than 3 cm and smaller than 12 cm
- 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)
- 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
- 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
- no invasion to or tumor thrombosis in the common bile duct or the first branch of the bile duct.
- 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
- No previous treatment for HCC
- No ascites or hepatic encephalopathy
- Age 20-85 years old
- ECOG performance status of 0 or 1
- 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% - Written informed consent
Exclusion Criteria
- synchronous or metachronous (within 5 years) malignancy
- active infection requiring systemic therapy
- body temperature >= 38 degrees Celsius
- female during pregnancy, within 28 days of postparturition, or during lactation
- severe psychological disorder
- receiving continuous systemic corticosteroid or immunosuppressant treatment
- poorly controlled diabetes mellitus
- poorly controlled hypertension
- unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
- interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT
- esophageal varices
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - overall survival
- Secondary Outcome Measures
Name Time Method