Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma

JRCT ID: jRCT1032200036

Registered date:22/05/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 20/12/2016
• Target sample size: 130
• Study type: Interventional

Intervention(s)

Carbon-ion radiation therapy
60 Gy(RBE) / 4 fractions
60 Gy(RBE) / 12 fractions (adjacent to organ at risk)

Outcome(s)

• Primary Outcome: Overall survival (Three-year overall survival)
• Secondary Outcome: Progression free survival (Three-year), Local progression free survival (Three-year), Adverse event, Incidence of radiation-induced liver disease(RILD)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically or clinically diagnosed primary hepatocellular carcinoma.
2) Untreated and absence of previous local therapy.
3) Solitary tumor without extrahepatic lesions.
4) The tumor is measurable and tumor size is less than 12 cm.
5) Absence of major portal vein and/or hepatic vein.
6) The tumor is in contact with the alimentary tract.
7) Unfit for resection or liver transplantation.
8) Unfit for percutaneous tumor ablation.
9) ECOG PS: 0-2.
10) Child-Pugh score of the patient is from 5 points to 9 points.
11) Absence of uncontrolled ascites and/or pleural effusion.
12) 20-year-old or older.
13) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.

Exclude criteria

1) Patients with any other active malignancies.
2) Having esophageal varices which are at great risk of bleeding
3) Having active infectious diseases
4) Having a fever greater than 38 degrees Celsius.
5) Having myocardial infarction or angina pectoris within 6 months.
6) Having interstitial pneumonitis, pulmonary fibrosis or severe respiratory disease such as pulmonary emphysema.
7) Having radiation hypersensitivity.
8) Associated with mental illness or manifestation complicating study participation.
9) Being pregnant or possible conception.
10) Miscellaneous inappropriate conditions judged by physicians.

Related Information

• Primary Sponsor: Ohno Tatsuya
• Secondary ID(s): UMIN 000020444