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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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
kai yun chen, phD
The second people's hospital
United States: Food and Drug Administration