The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 919 0
ChiCTR-TRC-00000160
Chinese Clinical Trial Register
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular carcinoma 237195 0
Condition category
Condition code
Cancer 237518 237518 0 0
Liver

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 236900 0
Treatment: Drugs
Comparator / control treatment
The control group received no adjuvant therapy for 18 weeks
Control group
Active

Outcomes
Primary outcome [1] 238326 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] 238326 0
Time from curative hepatectomy to the first diagnosis of tumor recurrence.
Primary outcome [2] 238327 0
Overall survival (OS)
Timepoint [2] 238327 0
Every year after randomization for 5 years
Secondary outcome [1] 244706 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] 244706 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 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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 consecutively numbered sealed envelopes and implementation was ensured by a research assistant.
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
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] 1872 0
China
State/province [1] 1872 0
Shanghai

Funding & Sponsors
Funding source category [1] 237296 0
Hospital
Name [1] 237296 0
Eastern Hepatobiliary Surgery Hospital
Address [1] 237296 0
No.225 Changhai Road, Shanghai 200438, China
Country [1] 237296 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] 236779 0
University
Name [1] 236779 0
Second Military Medical University
Address [1] 236779 0
No.800 Xiangyin Road, Shanghai 200433, China
Country [1] 236779 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239381 0
Institutional Review Board of Shanghai Eastern Hepatobiliary Surgery Hospital
Ethics committee address [1] 239381 0
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai 200438, China
Ethics committee country [1] 239381 0
China
Date submitted for ethics approval [1] 239381 0
08/07/2003
Approval date [1] 239381 0
20/07/2003
Ethics approval number [1] 239381 0
EHBH-RCT-2003-12

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29862 0
Address 29862 0
Country 29862 0
Phone 29862 0
Fax 29862 0
Email 29862 0
Contact person for public queries
Name 13109 0
XIA Yong
Address 13109 0
No.225 Changhai Road, Shanghai 200438,China
Country 13109 0
China
Phone 13109 0
+86-0-13601608920
Fax 13109 0
Email 13109 0
shenfengdfgd@yahoo.cn
Contact person for scientific queries
Name 4037 0
XIA Yong
Address 4037 0
No.225 Changhai Road, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University,Shanghai 200438,China
Country 4037 0
China
Phone 4037 0
+86-21-81875056
Fax 4037 0
Email 4037 0
shenfengdfgd@yahoo.cn

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