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Trial registered on ANZCTR
Registration number
ACTRN12609000574246
Ethics application status
Approved
Date submitted
9/07/2009
Date registered
14/07/2009
Date last updated
14/07/2009
Type of registration
Retrospectively registered
Titles & IDs
Public title
Postoperative adjuvant treatment with Capecitabine postpones recurrence of hepatocellular carcinoma after curative resection: a randomized controlled trial
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Scientific title
A prospective randomized controlled trial comparing recurrence outcome of adjuvant capecitabine therapy versus no adjuvant therapy for patients with hepatocellular carcinoma after curative resection
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Secondary ID [1]
919
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ChiCTR-TRC-00000160
Chinese Clinical Trial Register
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatocellular carcinoma
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Condition category
Condition code
Cancer
237518
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0
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Liver
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Beginning 3 to 4 weeks post operation, the capecitabine group received two weeks of capecitabine oral tablet at 1000 mg/m2, twice a day, 30 min after breakfast and dinner (Xeloda, 500 mg/tablet, Roche, Shanghai, China) followed by one week of rest. This three week regimen was repeated for a total of 4 to 6 cycles.
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Intervention code [1]
236900
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Treatment: Drugs
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Comparator / control treatment
The control group received no adjuvant therapy for 18 weeks
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Time from curative hepatectomy to the first diagnosis of tumor recurrence.
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Primary outcome [2]
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Overall survival (OS)
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Assessment method [2]
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Timepoint [2]
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Every year after randomization for 5 years
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Secondary outcome [1]
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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.
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Assessment method [1]
244706
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Timepoint [1]
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Every year after randomization for 5 years
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Eligibility
Key inclusion criteria
Patients whose age ranged from 18 to 70 years, with histologically proven hepatocellular carcinoma, and who underwent curative hepatectomy with less than 50% of the liver and with a tumor-free resection margin greater than 1 cm ;a postoperative decline of alpha-fetoprotein (AFP) level to less than 20 micro g/L; Child-Pugh class A; normalized hepatic function (glutamic pyruvic transaminase/glutamic oxaloacetic transaminase (GPT/GOT) equal to 2 times the upper normal limit; total serum bilirubin less than 34.2 micro mol/L); normal renal function and 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); life expectancy longer than 6 months; Karnofsky Performance Scale (KPS) score egual to 70.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Prior therapy with capecitabine, concomitant chemotherapy, allergy or history of severe adverse reactions to 5-fluoro-2,4(1H,3H)pyrimidinedione, bone or cerebral 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, or upper digestive tract disorders; Pregnant or lactating females and pre-menopausal women without using contraception.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Drawing consecutively numbered sealed envelopes and implementation was ensured by a research assistant.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2 / Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/08/2003
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Shanghai
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Eastern Hepatobiliary Surgery Hospital
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Address [1]
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No.225 Changhai Road, Shanghai 200438, China
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Country [1]
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China
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Primary sponsor type
Hospital
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Name
Eastern Hepatobiliary Surgery Hospital
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Address
No.225 Changhai Road, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
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Country
China
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Secondary sponsor category [1]
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University
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Name [1]
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Second Military Medical University
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Address [1]
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No.800 Xiangyin Road, Shanghai 200433, China
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Country [1]
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China
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Institutional Review Board of Shanghai Eastern Hepatobiliary Surgery Hospital
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Ethics committee address [1]
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Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
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Ethics committee country [1]
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China
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Date submitted for ethics approval [1]
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08/07/2003
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Approval date [1]
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20/07/2003
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Ethics approval number [1]
239381
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EHBH-RCT-2003-12
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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 postoperative adjuvant therapy with capecitabine could inhibit the recurrence of HCC after radical resection.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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XIA Yong
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Address
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No.225 Changhai Road, Shanghai 200438,China
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Country
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China
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Phone
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+86-0-13601608920
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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XIA Yong
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Address
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No.225 Changhai Road, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University,Shanghai 200438,China
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Country
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China
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Phone
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+86-21-81875056
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Fax
4037
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Email
4037
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[email protected]
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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.
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