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Trial registered on ANZCTR


Registration number
ACTRN12608000577314
Ethics application status
Approved
Date submitted
29/10/2008
Date registered
12/11/2008
Date last updated
12/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Randomized Controlled Trial of Preoperative Transarterial Chemoembolization for Resectable Large Hepatocellular Carcinoma
Scientific title
A prospective randomized controlled trial comparing survival outcome between patients with resectable large hepatocellular carcinoma (HCC) underwent preoperative transarterial chemoembolization (TACE) with partial hepatectomy and partial hepatectomy alone
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular carcinoma 3869 0
Condition category
Condition code
Cancer 4067 4067 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For preoperative TACE group, a vascular catheter for TACE was inserted through the femoral artery using the Seldinger technique, and hepatic angiography was performed. The catheter’s tip was inserted selectively into the left and right hepatic artery, or the tumor-feeding artery when technically possible. An emulsion of 5-Fluorouracil (5-FU) (1 gm), mitomycin C (MMC) (20 mg), cisplatin (5 mg) and lipiodol 10-30 ml (1 to 2 ml/cm diameter of the tumor) was injected. Preoperative TACE was begun within 10 days after randomization. TACE was repeated up to 3 times at an interval of 4 to 9 weeks. Partial hepatectomy was performed within 8 weeks from the last session of TACE.
Intervention code [1] 3597 0
Treatment: Other
Comparator / control treatment
Open partial hepatectomy without preoperative therapy was performed within 2 weeks after randomization for the control group
Control group
Active

Outcomes
Primary outcome [1] 4964 0
Disease-free survival rate
(Disease-free survival was defined from the date of randomization to the time when recurrent tumor was first diagnosed.)
Timepoint [1] 4964 0
Every year after randomization for 5 years
Primary outcome [2] 4965 0
Overall survival rate
(Overall survival was defined from the date of randomization to the time of death.)
Timepoint [2] 4965 0
Every year after randomization for 5 years
Primary outcome [3] 4966 0
Recurrence rate
(The diagnosis of tumor recurrence was based on cytologic/histologic evidences or on the noninvasive diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL))
Timepoint [3] 4966 0
Every year after randomization for 5 years.
Secondary outcome [1] 8379 0
Resection rate
(Resectability was defined as tumor was resectable with potential clear surgical margins)
Timepoint [1] 8379 0
After surgery
Secondary outcome [2] 8380 0
Procedure-related complications, e.g. liver failure, bleeding, intra-abdominal collection
Timepoint [2] 8380 0
Discharge after surgery
Secondary outcome [3] 8381 0
Hospital mortality
Timepoint [3] 8381 0
Discharge after surgery

Eligibility
Key inclusion criteria
Preoperative diagnosis of HCC > or =5 cm in diameter suitable for partial hepatectomy
Minimum age
16 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Received other treatment before; history or presence of other malignancies; inadequate liver function

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)
Drawing sealed, consecutively numbered and opaque envelopes after completing the preoperative evaluation
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 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1305 0
China
State/province [1] 1305 0

Funding & Sponsors
Funding source category [1] 4129 0
Self funded/Unfunded
Name [1] 4129 0
Address [1] 4129 0
Country [1] 4129 0
Primary sponsor type
Hospital
Name
Eastern Hepatobiliary Surgery Hospital
Address
The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
Country
China
Secondary sponsor category [1] 3651 0
University
Name [1] 3651 0
Faculty of Medicine, The Chinese University of Hong Kong
Address [1] 3651 0
Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR
Country [1] 3651 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6130 0
Institutional Review Board of Eastern Hepatobiliary Hospital
Ethics committee address [1] 6130 0
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
Ethics committee country [1] 6130 0
China
Date submitted for ethics approval [1] 6130 0
Approval date [1] 6130 0
15/06/2001
Ethics approval number [1] 6130 0
H2001007-P1(V)

Summary
Brief summary
Following curative liver resection for HCC, 50%-90% of postoperative death is due to recurrent disease. Any neoadjuvant or adjuvant therapy which decreases or delays the onset of recurrence, improves the results of liver resection. However, there is still no effective neoadjuvant therapy or adjuvant therapy for HCC. We conducted a randomized controlled trial to evaluate the effect of preoperative TACE on survival after resection of HCC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29068 0
Address 29068 0
Country 29068 0
Phone 29068 0
Fax 29068 0
Email 29068 0
Contact person for public queries
Name 12225 0
ZHOU Wei-Ping
Address 12225 0
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
Country 12225 0
China
Phone 12225 0
+86-21-25070792
Fax 12225 0
Email 12225 0
EHPHWP@126.com
Contact person for scientific queries
Name 3153 0
ZHOU Wei-Ping
Address 3153 0
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
Country 3153 0
China
Phone 3153 0
+86-21-25070792
Fax 3153 0
Email 3153 0
EHPHWP@126.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary