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Trial registered on ANZCTR


Registration number
ACTRN12610000081011
Ethics application status
Approved
Date submitted
22/01/2010
Date registered
22/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adjuvant iodine-125 brachytherapy for hepatocellular carcinoma patients underwent hepatectomy: a randomized controlled trial
Scientific title
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
Secondary ID [1] 1319 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular carcinoma 256650 0
Condition category
Condition code
Cancer 256811 256811 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 255886 0
Treatment: Other
Comparator / control treatment
The surgical procedures for the control group patients were the same as those of iodine-125 adjuvant brachytherapy group except that no iodine-125 seed implantation was applied.
Control group
Active

Outcomes
Primary outcome [1] 257674 0
Time to recurrence (TTR). Recurrence was confirmed by dynamic contrast-enhanced Computerised Tomography scanning or selective hepatic arteriography in subjects with an elevated alpha-fetoprotein level or with a newly identified mass.
Timepoint [1] 257674 0
Time from curative hepatectomy to the first diagnosis of tumor recurrence.
Primary outcome [2] 257675 0
Overall survival (OS). Overall survival was assessed by data linkage to medical records.
Timepoint [2] 257675 0
Every year after randomization for 5 years
Secondary outcome [1] 262986 0
Disease-free survival (DFS). Disease-free survival:Time from randomization to either recurrence or death. Patients alive and free of recurrence at the end of follow-up are surveyed via patient census.
Timepoint [1] 262986 0
Every year after randomization for 5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomization procedure was done without stratification by computer-generated random numbers between 0 and 1. Odd values of the first decimal place of the random number were assigned to the iodine-125 adjuvant brachytherapy group, and even values (including zero) were assigned to the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment outside Australia
Country [1] 2433 0
China
State/province [1] 2433 0
Guangdong

Funding & Sponsors
Funding source category [1] 256375 0
Government body
Name [1] 256375 0
The State Key Project on Infectious Diseases of China (No.2008ZX10002-025)
Country [1] 256375 0
China
Primary sponsor type
Hospital
Name
Eastern Hepatobiliary Surgery Hospital
Address
No.225 Changhai Road, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
Country
China
Secondary sponsor category [1] 251687 0
Hospital
Name [1] 251687 0
The Second Provincial People's Hospital of Guangdong Province
Address [1] 251687 0
No.1 Shiliugang Road, Guangzhou City 510317, China
Country [1] 251687 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258440 0
Institutional Review Board in the Second Provincial People's Hospital of Guangdong Province
Ethics committee address [1] 258440 0
Ethics committee country [1] 258440 0
China
Date submitted for ethics approval [1] 258440 0
10/02/2000
Approval date [1] 258440 0
16/02/2000
Ethics approval number [1] 258440 0
16/02/2000

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30746 0
Address 30746 0
Country 30746 0
Phone 30746 0
Fax 30746 0
Email 30746 0
Contact person for public queries
Name 13993 0
XIA Yong
Address 13993 0
No.225 Changhai Road, Shanghai 200438,China
Country 13993 0
China
Phone 13993 0
+86-0-13601608920
Fax 13993 0
Email 13993 0
xiay99@msn.com
Contact person for scientific queries
Name 4921 0
CHEN Kaiyun
Address 4921 0
No.1 Shiliugang Road, Guangzhou City 510317, China
Country 4921 0
China
Phone 4921 0
+86-0-13903061359
Fax 4921 0
Email 4921 0
chky3213300@126.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.