Hepatocellular Carcinoma Treated With Iodine-125 Implantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KaiYun Chen, The Second People's Hospital of GuangDong Province
ClinicalTrials.gov Identifier:
NCT01717729
First received: October 17, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Liver Carcinoma
Procedure: Radiofrequency Ablation
Radiation: iodine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Hepatocellular Carcinoma Treated With Radiofrequency Ablation With or Without Iodine-125 Implantation: A Prospective Study

Resource links provided by NLM:


Further study details as provided by The Second People's Hospital of GuangDong Province:

Primary Outcome Measures:
  • recurrence rate [ Time Frame: up to 6 years ] [ Designated as safety issue: Yes ]
    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:
  • One-, 2-, 3-, 4-, and 5-year overall survival rates [ Time Frame: up to 6 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 136
Study Start Date: January 2000
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01717729

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

No publications provided

Responsible Party: KaiYun Chen, SURGERY, The Second People's Hospital of GuangDong Province
ClinicalTrials.gov Identifier: NCT01717729     History of Changes
Other Study ID Numbers: ABT-2000-235
Study First Received: October 17, 2012
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014