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

Phase 3

Recruiting

• Conditions: resectable hepatocellular carcinoma

• Registration Number: JPRN-jRCT1032180197
• Lead Sponsor: Akimoto Tetsuo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-06
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: 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: 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)