NCT Number: NCT01717729
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 3
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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
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
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.
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.
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.
The Second People's Hospital of GuangDong Province
Other
Hepatocellular Carcinoma Treated With Radiofrequency Ablation With or Without Iodine-125 Implantation: A Prospective Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06720675
Adenocarcinoma, Carcinoma
Bologna, Italy
View Trial DetailsNCT02305459
Adenocarcinoma, Carcinoma
Vienna, Austria
View Trial DetailsNCT04288323
Adenocarcinoma, Carcinoma
La Jolla, California, United States
View Trial DetailsNCT06789224
Abdominal Neoplasms, Adenocarcinoma
Cologne, North Rhine-Westphalia, Germany
View Trial Details