The efficacy of stereotactic body radiation therapy for unresectable hepatocellular carcinoma: a single institution phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000625

Enrollment

Registered

2013-01-10

Start date

2013-04-04

Completion date

Unknown

Last updated

2019-04-23

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

Conditions

None listed

Interventions

Radiation : * Stereotactic Body Radiation Therapy 1. At least one week before CT simulation, three gold seeds were implanted into the liver parenchyma around the tumor under sonographic guidance in al

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Liver function as Child-Pugh class A 2. an Eastern Cooperative Oncology Group (ECOG) score: 0-1 3. the HCC lesions were not suitable for surgery or percutaneous ablative therapies 4. the HCC was = 6 cm across its longest diameter, or = 3 lesions were present with the sum of longest diameters = 6 cm 5. an adequate residual functional liver volume was evident (> 700 mL) 6. Women with childbearing potential and men must agree to use adequate contraception prior to study entry and during study participation 7. The patient must give written, informed consent

Exclusion criteria

Exclusion criteria: 1. Liver function as Child-Pugh class B or C 2. ECOG performance status?>1 3. the HCC was > 6 cm across its longest diameter, or > 3 lesions were present 4. Presence of major vascular invasion or extrahepatic metastasis 5. AST or ALT >5 X upper normal limit (200 IU/L) 6. no adequate residual functional liver volume due to liver cirrhosis or previous hepatic resection (< 700 mL) 7. No sufficient distance between the HCC and adjacent organs at risk, such as the duodenum, stomach, colon, and spinal cord (< 1cm) 8. Uncontrolled ascites or hepatic encephalopathy 9. prior history of external beam radiotherapy in upper abdomen 10. prior history of liver transplantation 11. History of active gastro-duodenal ulcers within the past 3 months 12. Pregnancy or breastfeeding. Patients don't agree to use adequate contraception 13. Previous or concurrent cancer that is distinct in primary site or histology from HCC, except skin cancer within 5 years 14. Any active clinically serious infections (Grade 3, CTCAE ver 4.0) 15. Patients who don't agree to written, informed consent

Design outcomes

Primary

Measure	Time frame
Local recurrence rate	—

Secondary

Measure	Time frame
Overall survival;Progression-free survival;objective response;recurrence pattern	—

Countries

Korea, Republic of

Contacts

Public ContactSang Min Yoon

Asan Medical Center

Outcome results