Hepatocellular Carcinoma Treated With Iodine-125 Implantation

October 26, 2012 updated by: KaiYun Chen, The Second People's Hospital of GuangDong Province

Hepatocellular Carcinoma Treated With Radiofrequency Ablation With or Without Iodine-125 Implantation: A Prospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Radio Therapeutics, Mountain View, Calif

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 years
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.
up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second People's Hospital of GuangDong Province

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Estimate)

October 30, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-2000-235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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