Stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma: Phase II trial

Not Applicable

• Conditions: hepatocellular carcinoma

• Registration Number: JPRN-UMIN000000640
• Lead Sponsor: iver radiothrapy group

Brief Summary

RESULTS: From 2007 to 2012, 101 patients were enrolled, and 90 were evaluable with a median follow-up of 41.7 months (range, 6.8-96.2 months). Thirty-two patients were treatment-naive, 20 were treated for newly diagnosed intrahepatic failure, and 38 were treated for residual or recurrent HCC as salvage therapy. Thirty-two patients did not receive TACE, 48 received insufficient TACE, and 10 attained full lipiodol accumulation. The 3-year local control rate was 96.3%, the 3-year liver-related cause-specific survival rate was 72.5%, and the overall survival rate was 66.7%. Grade 3 laboratory abnormalities were observed in 6 patients, and 8 patients had Child-Pugh scores that worsened by 2 points. CONCLUSIONS: SBRT achieved high local control and overall survival with feasible toxicities for patients with solitary HCC, despite rather stringent conditions. SBRT can be effective against solitary HCC in treatment-naive, intrahepatic failure, residual disease, and recurrent settings, taking advantage of its distinctive characteristics.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-01
• Study Completion: 2015-05-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1.Active infectious disease needing treatment except for external application. 2.In or suspected pregnancy or breast-feeding 3.mental disease which prohibit the patients from understanding this trial. 4.successive steroid use ( oral or intra-venous administration).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Three year local pogression free survival

Secondary Outcome Measures

Name	Time	Method
Three year overall survival Median overall survival Median overall progression free survival Median local progression free survival Median event free survival Type of progression Acute complication rate Chronic complication rate Severe complication rate