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

Phase 3

Recruiting

• Conditions: resectable hepatocellular carcinoma

• Registration Number: JPRN-UMIN000027811
• Lead Sponsor: Japan Clinical Oncology Group (JCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-19
• Last Update Posted: 17 October 2023
• Study Completion: 2029-12-19

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Not provided

Exclusion Criteria

1) synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers. 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 or receiving the routine administration of insulin 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: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival

Secondary Outcome Measures

Name	Time	Method
progression-free survival, patterns of failure, adverse events, acute non-hematological toxicities of Grade 3 or higher, late adverse reactions of Grade 3 or higher , serious adverse events, Child-Pugh score at 1, 3, and 5 years after the treatment, medical cost, quality of life (QOL), quality adjusted life years (QALY), incremental cost-effectiveness ratio (ICER)