Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation by Transcatheter Arterial Chemoembolization
| Tracking Information | |||||
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| First Received Date ICMJE | February 26, 2008 | ||||
| Last Updated Date | August 30, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00630240 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation by Transcatheter Arterial Chemoembolization | ||||
| Official Title ICMJE | Investigation the Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation in Patients With Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization | ||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: plasma |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | hepatocellular carcinoma caused by hepatitis B or C |
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| Condition ICMJE | Hepatocellular Carcinoma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
only one arm for study |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 53 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00630240 | ||||
| Other Study ID Numbers ICMJE | KMUH-IRB-960297, KMUH-IRB-960297 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Zu-Yau Lin/ Kaoshing Medical University Chung-Ho Memorial Hospital, Kaoshing Medical University Chung-Ho Memorial Hospital | ||||
| Study Sponsor ICMJE | Kaohsiung Medical University Chung-Ho Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Kaohsiung Medical University Chung-Ho Memorial Hospital | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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