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JCOG1315C: Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma (SPRING study)

Active, not recruiting
Conditions
resectable hepatocellular carcinoma
Registration Number
jRCT1032180197
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Recruiting
Sex
All
Target Recruitment
320
Inclusion Criteria
  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
Exclusion Criteria
  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

Study & Design

Study Type
Interventional
Study Design
parallel assignment
Primary Outcome Measures
NameTimeMethod
-

overall survival

Secondary Outcome Measures
NameTimeMethod

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