Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation by Transcatheter Arterial Chemoembolization

This study has been completed.
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00630240
First received: February 26, 2008
Last updated: August 30, 2009
Last verified: July 2009

February 26, 2008
August 30, 2009
February 2008
February 2009   (final data collection date for primary outcome measure)
The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be determined within one hour and at the third day after TACE. [ Time Frame: within one hour and at the third day after TACE ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00630240 on ClinicalTrials.gov Archive Site
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Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation by Transcatheter Arterial Chemoembolization
Investigation the Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation in Patients With Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization

Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with HCC. Few previous studies had demonstrated that the serum level of anticancer drug from patients treated by TACE was similar to those treated by systemic chemotherapy. The defense ability of the patient treated by TACE may thus be influenced by the leakage of anticancer drug to the systemic circulation. Since more than 80% patients with HCC also have liver cirrhosis, the toxicity for those anticancer drugs with hepatic transformation will be increased caused by the cirrhotic liver. The severity of pancytopenia in cirrhosis will be exacerbated by the effect of bone marrow suppression caused by anticancer drugs. Patients are at high risk for infection and hemorrhage. Therefore, it is of clinical importance to prevent or decrease the leakage of anticancer drugs to systemic circulation in patients treated by TACE. The procedures of TACE performed by previous studies were not constant and the distributions of tumor vessels were not evaluated in detail. The possible risk factors for the leakage of anticancer drug have not been investigated. This project will collect 60 patients with HCC including 30 patients with hepatitis B and 30 patients with hepatitis C. The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be determined within one hour and at the third day after TACE.

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Observational
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

plasma

Non-Probability Sample

hepatocellular carcinoma caused by hepatitis B or C

Hepatocellular Carcinoma
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1
only one arm for study
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with hepatocellular carcinoma caused by hepatitis B or C who will be treated by TACE

Exclusion Criteria:

  • Previously treated by antiviral drugs for hepatitis B or C
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00630240
KMUH-IRB-960297, KMUH-IRB-960297
Yes
Zu-Yau Lin/ Kaoshing Medical University Chung-Ho Memorial Hospital, Kaoshing Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Not Provided
Principal Investigator: z y lin, MD, Ms Kaohsiung Medical University
Kaohsiung Medical University Chung-Ho Memorial Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP