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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
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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
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Secondary ID [1]
282256
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None
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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:
intrahepatic cholangiocellular carcinoma
288782
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Condition category
Condition code
Cancer
289138
289138
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0
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Biliary tree (gall bladder and bile duct)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
286878
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
289250
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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
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Assessment method [1]
289250
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Timepoint [1]
289250
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Time from curative resection to the first diagnosis of tumor recurrence
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Primary outcome [2]
289251
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Overall survival (OS)
Overall survival: Time from operation to death. Patients alive at the end of follow-up are surveyed via patient census.
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Assessment method [2]
289251
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Timepoint [2]
289251
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Every year after operation for 2 years
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Secondary outcome [1]
302108
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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]
302108
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Timepoint [1]
302108
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Every year after randomization for 2 years
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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.
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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 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.
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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)
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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
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2013
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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
120
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4980
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China
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State/province [1]
4980
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Shanghai
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Funding & Sponsors
Funding source category [1]
287021
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Self funded/Unfunded
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Name [1]
287021
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Address [1]
287021
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Country [1]
287021
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China
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Primary sponsor type
Hospital
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Name
The Eastern Hepatobiliary Surgery Hospital
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Address
No.225 Changhai Road, Yangpu District, Shanghai,200438
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Country
China
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Secondary sponsor category [1]
285804
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None
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Name [1]
285804
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Address [1]
285804
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Country [1]
285804
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289060
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Clinical Research Ethics Committee of Eastern Hepatobiliary Surgery Hospital, Shanghai
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Ethics committee address [1]
289060
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No. 225, Changhai Road, Yangpu district, Shanghai,200438
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Ethics committee country [1]
289060
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China
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Date submitted for ethics approval [1]
289060
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22/02/2013
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Approval date [1]
289060
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01/04/2013
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Ethics approval number [1]
289060
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EHBHKY2013-001-06
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Summary
Brief summary
Postoperative recurrence of intrahepatic cholangiocellular carcinoma (ICC) 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 ICC. We conducted a randomized controlled trial to investigate whether adjuvant therapy with capecitabine after the operation could inhibit the recurrence of ICC after curative 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
39038
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Prof Jiamei Yang
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Address
39038
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Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
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Country
39038
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China
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Phone
39038
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+86-021-81875554
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Fax
39038
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Email
39038
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[email protected]
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Contact person for public queries
Name
39039
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Dr Yesheng Li
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Address
39039
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Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
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Country
39039
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China
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Phone
39039
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+86-021-81875554
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Fax
39039
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Email
39039
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[email protected]
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Contact person for scientific queries
Name
39040
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Dr Yesheng Li
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Address
39040
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Estern Hepatobiliary Surgery Hospital, NO.225, Changhai Road, Shanghai, 200438
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Country
39040
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China
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Phone
39040
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+86-021-81875554
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Fax
39040
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Email
39040
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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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