Hepatocellular Carcinoma Treated With Iodine-125 Implantation

• ClinicalTrials.gov Identifier: NCT01717729
• Recruitment Status: Completed
• First Posted: October 30, 2012
• Last Update Posted: October 30, 2012
• Sponsor: The Second People's Hospital of GuangDong Province
• Information provided by (Responsible Party): KaiYun Chen, The Second People's Hospital of GuangDong Province

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Liver Carcinoma	Procedure: Radiofrequency Ablation; Radiation: iodine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Hepatocellular Carcinoma Treated With Radiofrequency Ablation With or Without Iodine-125 Implantation: A Prospective Study
• Study Start Date: January 2000
• Actual Primary Completion Date: August 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: RFA-125I group; 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.	Procedure: Radiofrequency Ablation; For RFA, we used a commercially available system (RF 2000; Radio Therapeutics, Mountain View, Calif) and a needle electrode with a 15-gauge insulated cannula that had 10 hook-shaped expandable electrode tines with a diameter of 3.5 cm at expansion (LeVeen; Radio Therapeutics).The radioactivity per seed ranged from 0.5 to 0.6 millicuries (mCi); Other Name: Radio Therapeutics, Mountain View, Calif; Radiation: iodine; The 125I seeds (0.8 mm in diameter and 4.5mm in length) were enclosed in a NiTinol capsule (China Institute of Atomic Energy, Beijing). These seeds could produce 27.4-31.5 keV X-ray and 35.5 Kev γ ray, with a half-life of 59.6 days. The radioactivity per seed ranged from 0.5 to 0.6 millicuries (mCi).; Other Name: iodine-125 seed
Active Comparator: RFA-only group; (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.	Procedure: Radiofrequency Ablation; For RFA, we used a commercially available system (RF 2000; Radio Therapeutics, Mountain View, Calif) and a needle electrode with a 15-gauge insulated cannula that had 10 hook-shaped expandable electrode tines with a diameter of 3.5 cm at expansion (LeVeen; Radio Therapeutics).The radioactivity per seed ranged from 0.5 to 0.6 millicuries (mCi); Other Name: Radio Therapeutics, Mountain View, Calif

Outcome Measures

Primary Outcome Measures :

1. recurrence rate [ Time Frame: 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 :

1. One-, 2-, 3-, 4-, and 5-year overall survival rates [ Time Frame: up to 6 years ]
   urvival time was defined as the interval between the first treatment and either death or last follow-up visit.
2. Complete Ablation [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

The Second People's Hospital of GuangDong Province

Investigators

• Study Chair: kai yun chen, phD; The second people's hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen K, Chen G, Wang H, Li H, Xiao J, Duan X, He J, He K, Xiang G. Increased survival in hepatocellular carcinoma with iodine-125 implantation plus radiofrequency ablation: a prospective randomized controlled trial. J Hepatol. 2014 Dec;61(6):1304-11. doi: 10.1016/j.jhep.2014.07.026. Epub 2014 Jul 24.

• Responsible Party: KaiYun Chen, SURGERY, The Second People's Hospital of GuangDong Province
• ClinicalTrials.gov Identifier: NCT01717729
• Other Study ID Numbers: ABT-2000-235
• First Posted: October 30, 2012
• Last Update Posted: October 30, 2012
• Last Verified: October 2012

Keywords provided by KaiYun Chen, The Second People's Hospital of GuangDong Province:

HCC, RFA, Iodine-125, Recurrence

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Iodine; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Physiological Effects of Drugs