Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation by Transcatheter Arterial Chemoembolization
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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 |
- 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 |
hepatocellular carcinoma caused by hepatitis B or C
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| Taiwan | |
| Division of Hepatobiliary Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, No. 100 Tzyou 1st Road | |
| Kaohsiung, Taiwan, 807 | |
| 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 Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 17, 2013