Hepatocellular Carcinoma Treated With Iodine-125 Implantation

Phase 3

Completed

• Conditions: Liver Carcinoma
• Interventions: Procedure: Radiofrequency Ablation; Radiation: iodine

• Registration Number: NCT01717729
• Lead Sponsor: The Second People's Hospital of GuangDong Province

Brief Summary

To prospectively evaluate whether use of combined radiofrequency ablation (RFA) and percutaneous iodine-125 (125I) seeds implantation results in better survival compared with use of RFA alone in patients with hepatocellular carcinoma.

Detailed Description

This study was local ethical committee approved; all patients gave written informed consent. A total of 136 patients were randomly assigned to undergo RFA-125I (n = 68; 42 men, 26 women; mean age, 50.7 years; age range, 29-73 years) or RFA alone (n = 68; 47 men, 21 women; mean age, 48.9 years; age range, 30-74 years). Patients with viable tumors at computed tomography (CT) 4 weeks after treatment received additional treatment. Rates of local tumor progression and overall survival were evaluated by using Kaplan-Meier and log-rank tests, respectively. The relative prognostic significance of variables in predicting overall survival and the time to tumor recurrence or metastasis were assessed with multivariate Cox proportional hazards regression and logistic regression analyses, respectively.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2012-08
• Status Verified: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-26
• Last Update Submitted: 2012-10-26
• Study First Posted: 2012-10-30
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

(a) age 18-75 years and refusal to undergo surgery; (b) a solitary HCC 7.0 cm in diameter or smaller or multiple (up to three) HCCs 3.0 cm in diameter or smaller; (c) lesions visible at ultrasonography (US), with an acceptable and safe path between the lesion and the skin seen on the US scan; (d) no extrahepatic metastasis; (e) no imaging evidence of tumor invasion into the major portal or hepatic vein branches; (f) no history of encephalopathy, ascites refractory to diuretics, or variceal bleeding; (g) a platelet count of more than 40 000 cells/mm3 and (h) no previous treatment for HCC except liver resection.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA-125I group	Radiofrequency Ablation	The combination RFA and 125I (RFA-125I) (n = 68; 42 men, 26 women; mean age, 50.7 years; age range, 29-73 years) In this group, patients were accepted not only radiofrequency ablation (RFA) but also iodine-125.
RFA-125I group	iodine	The combination RFA and 125I (RFA-125I) (n = 68; 42 men, 26 women; mean age, 50.7 years; age range, 29-73 years) In this group, patients were accepted not only radiofrequency ablation (RFA) but also iodine-125.
RFA-only group	Radiofrequency Ablation	(n = 68; 47 men, 21 women; mean age, 48.9 years; age range, 30-74 years) In tis group,the patient were just peformed radiofrequency ablation alnoe.

Primary Outcome Measures

Name	Time	Method
recurrence rate	up to 6 years	The primary endpoint was the time to recurrence(TTR) was measured from the date of treatment to the time when the recurrent tumor was first diagnosed. At spiral CT after treatment, residual viable tumor tissue was considered to be present if enhancing areas were seen within the tumor on either arterial phase or portal venous phase images. Depending on the initial random treatment assignment, RFA-125I or RFA alone was repeated. Magnetic resonance (MR) imaging was performed if there was uncertainty at CT as to whether residual viable tumor tissue was present.

Secondary Outcome Measures

Name	Time	Method
One-, 2-, 3-, 4-, and 5-year overall survival rates	up to 6 years	urvival time was defined as the interval between the first treatment and either death or last follow-up visit.
Complete Ablation	up to 6 years	At spiral CT 4 weeks after treatment, residual viable tumor tissue was considered to be present if enhancing areas were seen within the tumor on either arterial phase or portal venous phase images.