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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Liver Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

recurrence rate

Outcome 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.

Outcome Time Frame:

up to 6 years

Safety Issue:

Yes

Principal Investigator

kai yun chen, phD

Investigator Role:

Study Chair

Investigator Affiliation:

The second people's hospital

Authority:

United States: Food and Drug Administration

Study ID:

ABT-2000-235

NCT ID:

NCT01717729

Start Date:

January 2000

Completion Date:

October 2012

Related Keywords:

  • Liver Carcinoma
  • HCC, RFA, Iodine-125, Recurrence
  • Carcinoma
  • Carcinoma, Hepatocellular

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