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A phase I trial of stereotactic body radiotherapy for limited hepatocellular carcinoma

A phase I trial of stereotactic body radiotherapy for limited hepatocellular carcinoma - HCC-SBRT P1 Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003090
Enrollment
12
Registered
2010-01-25
Start date
2010-01-05
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

A total dose of 32-64 Gy is delivered in 4 fractions over 4-8 days

Sponsors

Division of Radiation Oncology and division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathologically or radiologically diagnosed hepatocellular carcinoma 2) Single lesion with 5 cm or less in size 3) Ineligible for surgical resection 4) Ineligible for percutaneous local ablative therapy 5) Liver function with Child pugh score 5-6 (class A) or 7-8 (class B) 6) Normal liver volume of 800ml or more 7) Satisfy the liver tolelance dose 8) Dose not exceed the tolelance dose of surrounding normal tissues 9) ECOG Performance Status of 0-2

Exclusion criteria

Exclusion criteria: 1) Uncontrolled ascites 2) Gastric/esophageal varix which needs preventive treatment 3) Tumor thrumbus in main trunk of portal vein or IVC 4) Case with critical complication 5) Simultaneous cancer 6) In pregnancy or with expectation of pregnancy

Design outcomes

Primary

MeasureTime frame
Incidence of dose limitting toxicity(DLT)

Secondary

MeasureTime frame
Tumor response Local progression free survival Progression free survival Overall survival Adverse effects

Countries

Japan

Contacts

Public ContactHiroshi Mayahara

National Cancer Center Hospital, Tokyo, Japan Division of Radiation Oncology

mayah1jp@yahoo.co.jp03-3542-2511

Outcome results

None listed

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