JPRN-UMIN000027811
Recruiting
Phase 3
on-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma(JCOG1315C, SPRING study) - Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinoma(JCOG1315C, SPRING study)
Japan Clinical Oncology Group (JCOG)0 sites290 target enrollmentJune 19, 2017
Conditionsresectable hepatocellular carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- resectable hepatocellular carcinoma
- Sponsor
- Japan Clinical Oncology Group (JCOG)
- Enrollment
- 290
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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