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
  Purpose

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.


Condition
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Investigation the Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation in Patients With Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

plasma


Enrollment: 53
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
only one arm for study

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hepatocellular carcinoma caused by hepatitis B or C

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00630240

Locations
Taiwan
Division of Hepatobiliary Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, No. 100 Tzyou 1st Road
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: z y lin, MD, Ms Kaohsiung Medical University
  More Information

No publications provided

Responsible Party: Zu-Yau Lin/ Kaoshing Medical University Chung-Ho Memorial Hospital, Kaoshing Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT00630240     History of Changes
Other Study ID Numbers: KMUH-IRB-960297, KMUH-IRB-960297
Study First Received: February 26, 2008
Last Updated: August 30, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
epirubicin
mitomycin C
cisplatin
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 16, 2014