Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000471987
Ethics application status
Approved
Date submitted
4/05/2011
Date registered
6/05/2011
Date last updated
6/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A Comparison of Recurrence After Radical Hepatectomy in Hepatocellular Carcinoma (HCC) Patients Underwent Intraoperative Adjuvant Epirubicin therapy or Not
Scientific title
A prospective randomized controlled trial comparing recurrence outcome of intraoperative adjuvant epirubicin therapy from gastroepiploic vein versus no adjuvant therapy for patients with hepatocellular carcinoma after radical hepatectomy
Secondary ID [1] 260007 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hepatocellular carcinoma 265666 0
Condition category
Condition code
Cancer 265799 265799 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After the radical resection, the adjuvant group received the single injection of 20mg epirubicin from gastroepiploic vein during the operation.
Intervention code [1] 264425 0
Treatment: Drugs
Comparator / control treatment
After the radical resection, the no adjuvant group received the single injection of 20ml physiological saline from gastroepiploic vein during the operation.
Control group
Placebo

Outcomes
Primary outcome [1] 266552 0
Time to recurrence.
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] 266552 0
Time from curative hepatectomy to the first diagnosis of tumor recurrence
Primary outcome [2] 266553 0
Overall Survival from randomization to death.
Death was confirmed by a Statement of Death or Death certificate approved by a licensed medical practitioner.
Timepoint [2] 266553 0
Every year after randomization for 5 years
Secondary outcome [1] 276020 0
Disease-free survival (DFS)
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] 276020 0
Every year after randomization for 5 years

Eligibility
Key inclusion criteria
1.Patients with histologically proven hepatocellular carcinoma
2.Underwent curative hepatectomy with less than 50% of the liver and with a tumor-free resection margin greater than 1 cm
3.Postoperative decline of alpha-fetoprotein (AFP) level to less than 20 micro g/L.
4.Child-Pugh class A:normalized hepatic function(glutamic pyruvic transaminase/glutamic oxaloacetic transaminase less than 2 times the upper normal limit; total serum bilirubin less than 34.2 micro mol/L);
5.Normal renal function & Hematological parameters (serum creatinine less than 132 micro mol/L; white blood cell (WBC) count equal to 2500×109/L; platelet count (PTL) equal to 40×109/L).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior therapy with chemotherapy, allergy or history of severe adverse reactions to epirubicin, the other regrion metastases, and malignant tumors in other regions of the body over the previous five years; peripheral neuropathy, history of central nervous system diseases, abnormal electrocardiogram findings, psychiatric disorders; severe cardiac, metabolic and/or infectious diseases; active peptic ulcer disease requiring treatment, absorption disorders; Pregnant or lactating females.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3387 0
China
State/province [1] 3387 0
Shanghai

Funding & Sponsors
Funding source category [1] 264895 0
Hospital
Name [1] 264895 0
Eastern Hepatobiliary Surgery Hospital
Country [1] 264895 0
China
Primary sponsor type
Hospital
Name
Eastern Hepatobiliary Surgery Hospital
Address
No.225 Changhai Road, Shanghai 200438
Country
China
Secondary sponsor category [1] 264104 0
Individual
Name [1] 264104 0
Binghua Dai
Address [1] 264104 0
No.225 Changhai Road, Shanghai 200438
Country [1] 264104 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266982 0
Ethics Committee of Eastern Hepatobiliary Surgery Hospital
Ethics committee address [1] 266982 0
No.225 Changhai Road, Shanghai 200438
Ethics committee country [1] 266982 0
China
Date submitted for ethics approval [1] 266982 0
Approval date [1] 266982 0
30/04/2011
Ethics approval number [1] 266982 0
EHBH-RCT-2011-412

Summary
Brief summary
Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem that hampers the efficacy of surgical resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective for HCC. We conducted a randomized controlled trial to investigate whether adjuvant therapy with epirubicin intraoperative could inhibit the recurrence of HCC after radical resection.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32494 0
Address 32494 0
Country 32494 0
Phone 32494 0
Fax 32494 0
Email 32494 0
Contact person for public queries
Name 15741 0
Dr. Binghua Dai
Address 15741 0
No.225 Changhai Road, Shanghai 200438,China
Country 15741 0
China
Phone 15741 0
+86-0-13918062394
Fax 15741 0
Email 15741 0
yehaiwen@hotmail.com
Contact person for scientific queries
Name 6669 0
Dr. Jiamei Yang
Address 6669 0
No.225 Changhai Road, Shanghai 200438,China
Country 6669 0
China
Phone 6669 0
+8621-81875551
Fax 6669 0
Email 6669 0
Jmyang@smmu.edu.cn

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.