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Trial registered on ANZCTR


Registration number
ACTRN12612000751875
Ethics application status
Approved
Date submitted
10/07/2012
Date registered
13/07/2012
Date last updated
13/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomized trial comparing surgery therapy versus radiotherapy combined with transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) with portal vein invasion
Scientific title
Compare the effect of surgery therapy versus radiotherapy Combined with transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) with portal vein invasion
Secondary ID [1] 280824 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
confirm the beneficial role of surgery therapy or three-dimensional conformal radiotherapy (3D-CRT) on hepatocellular carcinoma (HCC) patients with portal vein tumor thrombus (PVTT) 286892 0
Condition category
Condition code
Cancer 287212 287212 0 0
Liver
Surgery 287213 287213 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Liver resection was carried out by a clamp crushing method with Pringle maneuver. The clamp crushing method is a fracture or crushing technique during the parechymatous transection of the liver tissue by using a clamp.Pringle maneuver is a method of inflow hepatic vascular occlusion in liver resection.Thrombectomy was performed if necessary depending on the location and extent of the portal vein tumor thrombus (PVTT).The surgery lasts 2-3 hours which was decided by the time of liver resection.
Intervention code [1] 285251 0
Treatment: Surgery
Intervention code [2] 285252 0
Treatment: Other
Comparator / control treatment
In control groups,patients received three-dimensional conformal radiotherapy (3D-CRT) to the tumor and portal vein tumor thrombus (PVTT) for a total radiation dose which ranged from 30 to 52 Gy (median 40 Gy).The radiation was given at a daily dose of 3.0-4.0 Gy per fraction, five times per week over 2 weeks.
Transcatheter arterial chemoembolization (TACE) was performed using a catheter selectively inserted into the proper, right or left hepatic artery. 5-Fluorouracil (5-FU) 1.0g, mitomycin C (MMC) 20mg, Cisplatin 5 mg and Lipiodol 10 to 30 ml (at 1 to 2 ml/cm of the diameter of the tumor) were given by intravenous (IV) injections.TACE was performed 3 to 4 weeks after the radiotherapy and repeated once every 4 to 6 weeks as long as the patient could tolerate the treatment.
Control group
Active

Outcomes
Primary outcome [1] 287498 0
the 1-, 2- and 3-year overall survival rate in surgery therapy (experimental group) versus radiology group(control group) for HCC.All patients were followed-up by one team of doctors to get the information of their survival.
Timepoint [1] 287498 0
Once a year from 1-3 years postoperation
Secondary outcome [1] 298290 0
Complications including postoperative hemmorrhage,bile leak ,wound infection ,etc.
Postoperative complications were monitored, assessed and treated by one team of doctors.
Timepoint [1] 298290 0
after surgery in one month
Secondary outcome [2] 298305 0
Serum alpha fetoprotein(AFP) assay will be assessed by blood test. If the AFP>=400ug/L, it would be recorded as the sign of recurrence or metastases, further examination such as abdominal contrast CT or chest X-ray should be performed.
Timepoint [2] 298305 0
every 1 month postoperation
Secondary outcome [3] 298307 0
Contrast CT scan and chest X-ray
Abdominal contrast CT scan was performed for surveillance of tumor recurrence.
Chest X-ray was performed for surveillance of lung metastases.
Timepoint [3] 298307 0
every 3 month postoperation
Secondary outcome [4] 298314 0
Abdominal ultrasound was performed for surveillance of tumor recurrence.
Timepoint [4] 298314 0
every 1 month postoperation

Eligibility
Key inclusion criteria
1. resectable HCC with PVTT; 2. there was no previous treatment; 3.there were no other malignancies; 4. compensated cirrhosis with Child-Pugh class A, or B; 5. there were no tumor invasion of hepatic vein, bile duct,inferior vena cava; 6.there was no extrahepatic metastasis; 7.patients had no serious associated medical diseases;8. Understanding and being willing to sign the informed consent form
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.cannot be follow-up 2.severe liver, renal, or brain dysfunction; 3. with tumor thrombi in the hepatic vein 4.with extrahepatic metastasis

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)
All eligible patients were randomly assigned to either the surgery group or the control group by drawing sealed, consecutively numbered and opaque envelopes after completing the preoperative evaluation. The randomisation table was created by computerised sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
create the random order for the allocation of subjects into different groups. Simple randomisation by using a randomisation table created by computerised sequence. If stratified allocation was employed in the study, the in hospital time used for the stratification.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment outside Australia
Country [1] 4400 0
China
State/province [1] 4400 0

Funding & Sponsors
Funding source category [1] 285617 0
Hospital
Name [1] 285617 0
Eastern Hepatobiliary Surgery Hospital
Country [1] 285617 0
China
Primary sponsor type
Hospital
Name
Eastern Hepatobiliary Surgery Hospital
Address
Second Military Medical University,changhai street Shanghai, China,200438
Country
China
Secondary sponsor category [1] 284449 0
University
Name [1] 284449 0
Second Military Medical University
Address [1] 284449 0
changhai street ,Shanghai, China,200438
Country [1] 284449 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287614 0
Ethic Committee of Shanghai Eastern Hepatobiliary Surgery Hospital
Ethics committee address [1] 287614 0
Ethics committee country [1] 287614 0
China
Date submitted for ethics approval [1] 287614 0
Approval date [1] 287614 0
17/10/2008
Ethics approval number [1] 287614 0
ehbhky-2008021

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

Contacts
Principal investigator
Name 34424 0
Address 34424 0
Country 34424 0
Phone 34424 0
Fax 34424 0
Email 34424 0
Contact person for public queries
Name 17671 0
Tangqinghe
Address 17671 0
225 Changhai Road, 200438, Shanghai,China
Country 17671 0
China
Phone 17671 0
+86 021 81875532
Fax 17671 0
Email 17671 0
peking301@hotmail.com
Contact person for scientific queries
Name 8599 0
Zhouweiping
Address 8599 0
225 Changhai Road, 200438, Shanghai,China
Country 8599 0
China
Phone 8599 0
+86 021 81875531
Fax 8599 0
Email 8599 0
datang1978@sina.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.