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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01116635 |
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Date of registration:
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03/05/2010 |
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Primary sponsor: |
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Public title:
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Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)
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Scientific title:
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Phase I/II Study Examining Pharmacokinetics, Adverse Events, and Surgically Resected Histopathological Response Utilizing a Dose Escalation Model of Doxorubicin Loaded Drug Eluting Superabsorbent Polymer Microspheres in Surgically Resectable Hepatocellular Carcinoma in Humans |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01116635 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Alan Weiss, MD |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Charles Scudamore, MD |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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David Owen, MD |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Ellen Wasan, PhD |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Eric Yoshida, MD |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Jo-Ann Ford, RN |
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Sharlene Gill, MD |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Sigfried Erb, MD |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Stephen Chung, MD |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Stephen Ho, MD |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma
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Intervention(s)
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Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy
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Primary Outcome(s)
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Histopathological correlation with surgically resected tumor
[Time Frame: No]
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Secondary Outcome(s)
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Dose limiting toxicities
[Time Frame: No]
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maximum tolerated dose
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serum doxorubicin release patter
[Time Frame: No]
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Secondary ID(s)
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H08-02833
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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