Skip to content

Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)

Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703) - Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000020571
Enrollment
35
Registered
2016-01-14
Start date
2011-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

None listed

Sponsors

Gunma University Heavy Ion Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) pathollogically or clinically diagnosed hepatocellular carcinoma. 2) Satellite nodules (daughter nodules) and/or tumor thrombus are contiguous or adjacent to the main tumor. 3) Tumor is measurable and tumor size is 10 cm or less than 10 cm. 4) Absence of invasion to the main branch of portal vein, common hepatic duct, or inferior vena cava. 5) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition) 6) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE. 7) No other intrahepatic lesion or at least 2 years passed after the previous curative therapy to other intraheaptic lesions. 8) Perfomance status of the patient is from 0 to 2. 9) Child-Pugh score of the patient is from 5 points to 9 points. 10) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.

Exclusion criteria

Exclusion criteria: 1) History of radiation therapy to the lesion of interest. 2) The alimentary tract was adjacent to the target lesion. 3) Patients with any other active malignancies. 4) Patient with severe comorbidity.

Design outcomes

Primary

MeasureTime frame
3-year local control rate

Secondary

MeasureTime frame
Overall survival Progression free survival Response rate Acute toxicity(within 6 months) Late toxicity(6 months or later)

Countries

Japan

Contacts

Public ContactTatsuya Ohno

Gunma University Heavy Ion Medical Center

tohno@gunma-u.ac.jp027-220-8378

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026