None listed
Conditions
Brief summary
Recurrence is a critical issue for curative resection of hepatocellular carcinoma (HCC). To date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective for HCC. This study was to evaluate the inhibitory effect of adjuvant iodine-125 brachytherapy on postoperative recurrence of HCC.
Interventions
In adjuvant iodine-125 brachytherapy group, based on curative resection of liver tumor, the wound was stanched carefully; the wound surface area was measured and the data were entered into the computer to determine the quantity and dose of seed implantation. The 0.8 mm in diameter and 4.5mm in length iodine-125 seeds 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 r-ray, with a half life of 59.6 days. The radioactivity per seed ranged 0.5-0.6 mCi. The seeds that had undergone megatemperature sterilizing were implanted into the normal liver tissue near the cut surface at 1-cm intervals. Biological fibrin glue was applied onto the wound surface, which was then covered with gelatin sponge or hemostatic gauze after saturation and fixation to prevent displacement of the iodine-125 seeds. A median of 25 iodine-125 seeds per patient (range, 18–34seeds) were implanted, with a median total implanted activity of 12.5 mCi (range, 9.0–20.4 mCi).The duration range of the seed implantation process were 5-10 minutes.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients whose age ranged from 18 to 70 years with histologically proven hepatocellular carcinoma and who underwent curative hepatectomy were eligible to participate in the study. Other eligibility criteria included Child-Pugh class A, adequate bone marrow and renal function (White blood cell (WBC) count more than 4.0×10^9/L, platelet (PTL) count more than 50×10^9/L, and serum creatinine (CR) less than 1.5mg/dl), normal major organ (heart and lung) function, and Karnofsky Performance Scale (KPS) score more than 70.
Exclusion criteria
Exclusion criteria included active thyroid disease, serious concurrent medical illnesses, extrahepatic diseases, major vascular involvement, previous anticancer treatment before surgery, histologically proved non-HCC tumors and women who were pregnant or breastfeeding.