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Adjuvant iodine-125 brachytherapy for hepatocellular carcinoma patients underwent hepatectomy: a randomized controlled trial

A prospective randomized controlled trial comparing recurrence outcome of adjuvant iodine-125 brachytherapy versus no adjuvant therapy for patients with hepatocellular carcinoma after curative resection

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000081011
Enrollment
68
Registered
2010-01-22
Start date
2000-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

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

Eastern Hepatobiliary Surgery Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 24, 2026