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Trial registered on ANZCTR


Registration number
ACTRN12613000519752
Ethics application status
Approved
Date submitted
5/04/2013
Date registered
10/05/2013
Date last updated
10/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial to evaluate the effectiveness of capecitabine as a postoperative adjuvant regimen in inhibiting the recurrence of intrahepatic cholangiocarcinoma after curative resection
Scientific title
A randomized controlled trial to evaluate the effectiveness of capecitabine as a postoperative adjuvant regimen in inhibiting the recurrence of intrahepatic cholangiocarcinoma after curative resection
Secondary ID [1] 282256 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intrahepatic cholangiocellular carcinoma 288782 0
Condition category
Condition code
Cancer 289138 289138 0 0
Biliary tree (gall bladder and bile duct)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After one month of the curative resection, the adjuvant group received 1250mg/m2 capecitabine tablets two times per one day by oral; Taking two weeks and have one week dicontinuation as one course of treatment, repeated six courses. The monthly review of the blood, liver, renal, CA-19-9, alpha-fetoprotein (AFP) and liver ultrasound. The three-monthly review of liver-enhanced CT or MRI. If bone pain, line ECT or check.
adverse reactions processing program:
a. Grade III adverse reactions: capecitabine dose reduced 25%
b. Grade III adverse reactions last more than 2 weeks or grade IV adverse reactions: stop taking capecitabine
c. WBC <2.5 × 109 / L and/or PLT <40 × 109 / L: capecitabine dose reduced 25% and give drugs which can rised white blood cells and/or platelet counts
d. WBC and/or platelet count still continued to decline after the dose of capecitabine reduced: stop taking capecitabine
A standardized clinical data management procedure will be carried out to make sure all of the data including the data on the adherences satisfy good clinical practice (GCP) requirements. All of the data will be entered in a verified database while the original paper records will be kept for at least 5 years. To make sure that the data in the database is consistent with the original one, a data validation process will be carried out. Disagreements were adjudicated by answering the query forms after referring to the original records.
Intervention code [1] 286878 0
Treatment: Drugs
Comparator / control treatment
After R0 resection, patients with ICC will be observed or participate in clinical trials according to NCCN2012 guideline. So the control group will get best supportive care.
Control group
Active

Outcomes
Primary outcome [1] 289250 0
Time to recurrence (TTR)
Recurrence was confirmed by dynamic contrast-enhanced Computerised Tomography scan or selective hepatic arteriography in subjects with an elevated CA-19-9 level or with a newly identified mass
Timepoint [1] 289250 0
Time from curative resection to the first diagnosis of tumor recurrence
Primary outcome [2] 289251 0
Overall survival (OS)
Overall survival: Time from operation to death. Patients alive at the end of follow-up are surveyed via patient census.
Timepoint [2] 289251 0
Every year after operation for 2 years
Secondary outcome [1] 302108 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] 302108 0
Every year after randomization for 2 years

Eligibility
Key inclusion criteria
Patients whose age ranged from 18 to 70 years, with histologically proven intrahepatic cholangiocellular carcinoma, and who underwent curative hepatectomy with less than 50% of the liver and with a tumor-free resection margin greater than 1 cm; Child-Pugh class A; normalized hepatic function (glutamic pyruvic transaminase/glutamic oxaloacetic transaminase (GPT/GOT) less than or 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 greater than or equal to 2.5×109/L; platelet count (PLT) greater than or equal to 40×109/L); life expectancy longer than 6 months.
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 capecitabine, the other region metastases, and malignant tumors in other regions of the body over the previous two 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)
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
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 4980 0
China
State/province [1] 4980 0
Shanghai

Funding & Sponsors
Funding source category [1] 287021 0
Self funded/Unfunded
Name [1] 287021 0
Country [1] 287021 0
China
Primary sponsor type
Hospital
Name
The Eastern Hepatobiliary Surgery Hospital
Address
No.225 Changhai Road, Yangpu District, Shanghai,200438
Country
China
Secondary sponsor category [1] 285804 0
None
Name [1] 285804 0
Address [1] 285804 0
Country [1] 285804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289060 0
Clinical Research Ethics Committee of Eastern Hepatobiliary Surgery Hospital, Shanghai
Ethics committee address [1] 289060 0
Ethics committee country [1] 289060 0
China
Date submitted for ethics approval [1] 289060 0
22/02/2013
Approval date [1] 289060 0
01/04/2013
Ethics approval number [1] 289060 0
EHBHKY2013-001-06

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

Contacts
Principal investigator
Name 39038 0
Prof Jiamei Yang
Address 39038 0
Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
Country 39038 0
China
Phone 39038 0
+86-021-81875554
Fax 39038 0
Email 39038 0
yangjiamei2010@163.com
Contact person for public queries
Name 39039 0
Yesheng Li
Address 39039 0
Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
Country 39039 0
China
Phone 39039 0
+86-021-81875554
Fax 39039 0
Email 39039 0
leeyesheng@163.com
Contact person for scientific queries
Name 39040 0
Yesheng Li
Address 39040 0
Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
Country 39040 0
China
Phone 39040 0
+86-021-81875554
Fax 39040 0
Email 39040 0
leeyesheng@163.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.