Hepatocellular Carcinoma Treated With Iodine-125 Implantation
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ClinicalTrials.gov Identifier: NCT01717729 |
Recruitment Status :
Completed
First Posted : October 30, 2012
Last Update Posted : October 30, 2012
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Condition or disease | Intervention/treatment | Phase |
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Liver Carcinoma | Procedure: Radiofrequency Ablation Radiation: iodine | Phase 3 |
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 |
Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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.
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717729
Study Chair: | kai yun chen, phD | The second people's hospital |
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 Key Record Dates |
Last Update Posted: | October 30, 2012 |
Last Verified: | October 2012 |
HCC, RFA, Iodine-125, Recurrence |
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 |