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

JRCT ID: jRCT1032180197

Registered date:06/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: resectable hepatocellular carcinoma
• Date of first enrollment: 05/12/2017
• Target sample size: 320
• Study type: Interventional

Intervention(s)

Arm A: hepatectomy
Arm B: proton beam therapy
Non-hepatic hilar type: 66 Gy (RBE)/10 fractions, total treatment period 12-14 days
Hepatic hilar type: 72.6 Gy/22 fractions, total treatment period 30-32 days

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Akimoto Tetsuo
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000027811