Back to resultsHepatocellular Carcinoma Treated With Iodine-125 Implantation
Primary Purpose
Liver Carcinoma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Radiofrequency Ablation
iodine
Sponsored by
About this trial
This is an interventional treatment trial for Liver Carcinoma focused on measuring HCC, RFA, Iodine-125, Recurrence
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RFA-125I group
RFA-only group
Arm Description
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.
(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.
Outcomes
Primary Outcome Measures
recurrence rate
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
urvival time was defined as the interval between the first treatment and either death or last follow-up visit.
Complete Ablation
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.
Full Information
NCT ID
NCT01717729
First Posted
October 17, 2012
Last Updated
October 26, 2012
Sponsor
The Second People's Hospital of GuangDong Province
1. Study Identification
Unique Protocol Identification Number
NCT01717729
Brief Title
Hepatocellular Carcinoma Treated With Iodine-125 Implantation
Official Title
Hepatocellular Carcinoma Treated With Radiofrequency Ablation With or Without Iodine-125 Implantation: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second People's Hospital of GuangDong Province
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Carcinoma
Keywords
HCC, RFA, Iodine-125, Recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA-125I group
Arm Type
Experimental
Arm Description
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.
Arm Title
RFA-only group
Arm Type
Active Comparator
Arm Description
(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.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation
Other Intervention Name(s)
Radio Therapeutics, Mountain View, Calif
Intervention Description
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)
Intervention Type
Radiation
Intervention Name(s)
iodine
Other Intervention Name(s)
iodine-125 seed
Intervention Description
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).
Primary Outcome Measure Information:
Title
recurrence rate
Description
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.
Time Frame
up to 6 years
Secondary Outcome Measure Information:
Title
One-, 2-, 3-, 4-, and 5-year overall survival rates
Description
urvival time was defined as the interval between the first treatment and either death or last follow-up visit.
Time Frame
up to 6 years
Title
Complete Ablation
Description
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.
Time Frame
up to 6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kai yun chen, phD
Organizational Affiliation
The second people's hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
25064436
Citation
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.
Results Reference
derived
Learn more about this trial
Hepatocellular Carcinoma Treated With Iodine-125 Implantation
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