Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)

Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303) - Phase I trial of carbon-ion radiotherapy using 12 fractions for primary liver cancer adjacent to the alimentary tract (GUNMA1303)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020436

Enrollment

Registered

2016-01-05

Start date

2013-07-01

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

Primary liver cancer

Interventions

Carbon-ion radiation therapy Total dose 60.0-64.8 Gy(RBE) 12 fractions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) pathollogically or clinically diagnosed primary liver tumor (hepatocellular carcinoma or cholangiocellular carcinoma). 2) The distance between taget lesion and digestive tract is 1 cm or less than 1 cm. 3) Satellite nodules (daughter nodules) and/or tumor thrombus are contiguous or adjacent to the main tumor. 4) Tumor is measurable and tumor size is 10 cm or less than 10 cm. 5) Absence of invasion to the main portal vein, common hepatic duct, or inferior vena cava. 6) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition) 7) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE. 8) Child-Pugh score of the patient is from 5 points to 9 points. 9) Perfomance status of the patient is from 0 to 2. 8) Child-Pugh score of the patient is from 5 points to 9 points. 9) Expected survival over 6 months. 10) Perfomance status of the patient is from 0 to 2. 11) 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) Invasion to the adjacent organs. 3) Patient with severe comorbidity.

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicity Acute toxicity	—

Secondary

Measure	Time frame
Response rate Late toxicity	—

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