A randomized controlled trial of stereotactic body radiation therapy (SBRT) with radiofrequency ablation (RFA) for small hepatocellular carcinoma

A randomized controlled trial of stereotactic body radiation therapy (SBRT) with radiofrequency ablation (RFA) for small hepatocellular carcinoma - A randomized controlled trial of SBRT with RFA for small hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002488

Enrollment

288

Registered

2009-09-16

Start date

2009-09-01

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

Stereotactic body radiation therapy A total dose of 48 Gy is planned in 4 fractions over 4-8 days Percutaneous radiofrequency ablation One procedure per week, one or more procedures will be perfor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histopathologically confirmed carcinoma or a lesion showing characteristic features of hepatocellular carcinoma (HCC) on dynamic CT imaging (2) Either a single lesion 5 cm or less in diameter, or two lesions each 3 cm or less in diameter (3) Ineligibility for surgical resection or transplantation, or refusal to undergo surgical resection or transplantation (4) No vascular invasion and no extrahepatic metastasis (5) Liver function of Child-Pugh class A (6) Platelet count more than 50000 per cubic millimeter (7) Prothrombin time ratio (ie, normal time divided by patient's time) greater than 50% (8) ECOG performance status (PS) of 0 or 1

Exclusion criteria

Exclusion criteria: (1) Active infectious disease requiring treatment (2) In pregnancy or lactation, or with expectation of pregnancy (3) History of irradiation to body trunk for any disease (4) Implantation of a permanent pacemaker (5) Tumors abutting the stomach or intestinal loop (6) Simultaneous malignancies

Design outcomes

Primary

Measure	Time frame
Three-year survival	—

Secondary

Measure	Time frame
Three-year local tumor control rate Incidence of adverse events	—

Countries

Japan

Contacts

Public ContactShinji Katsushima

National Hospital Organization Kyoto Medical Center Department of Gastroenterology

skatsush@kyotolan.hosp.go.jp075-641-9161

Outcome results

None listed

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