Adjuvant iodine-125 brachytherapy for hepatocellular carcinoma patients underwent hepatectomy: a randomized controlled trial

Phase 2

Completed

• Conditions: Hepatocellular carcinoma; Cancer - Liver

• Registration Number: ACTRN12610000081011
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Patients whose age ranged from 18 to 70 years with histologically proven hepatocellular carcinoma and who underwent curative hepatectomy were eligible to participate in the study. Other eligibility criteria included Child-Pugh class A, adequate bone marrow and renal function (White blood cell (WBC) count more than 4.0×10^9/L, platelet (PTL) count more than 50×10^9/L, and serum creatinine (CR) less than 1.5mg/dl), normal major organ (heart and lung) function, and Karnofsky Performance Scale (KPS) score more than 70.

Exclusion Criteria

Exclusion criteria included active thyroid disease, serious concurrent medical illnesses, extrahepatic diseases, major vascular involvement, previous anticancer treatment before surgery, histologically proved non-HCC tumors and women who were pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to recurrence (TTR). Recurrence was confirmed by dynamic contrast-enhanced Computerised Tomography scanning or selective hepatic arteriography in subjects with an elevated alpha-fetoprotein level or with a newly identified mass.[Time from curative hepatectomy to the first diagnosis of tumor recurrence.];Overall survival (OS). Overall survival was assessed by data linkage to medical records.[Every year after randomization for 5 years]

Secondary Outcome Measures

Name	Time	Method
Disease-free survival (DFS). Disease-free survival:Time from randomization to either recurrence or death. Patients alive and free of recurrence at the end of follow-up are surveyed via patient census.[Every year after randomization for 5 years]