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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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ANZCTR |
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Last refreshed on:
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22 February 2013 |
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Main ID: |
ACTRN12607000090415 |
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Date of registration:
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29/01/2007 |
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Primary sponsor: |
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Public title:
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Phase II Trial of Temozolomide and Caelyx in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy
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Scientific title:
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Phase II Trial of Temozolomide and Caelyx in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy to improve six month progression free survival |
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Date of first enrolment:
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1/02/2007 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://www.anzctr.org.au/ACTRN12607000090415.aspx |
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Study type:
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Interventional |
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Study design:
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Nonrandomised trial
Single group |
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Countries of recruitment
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Australia
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Contacts
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Name:
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Professor Mark Rosenthal |
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Address:
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Department of Medical Oncology
Royal Melbourne Hospital
Grattan Street
VIC 3050, Australia
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Telephone:
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+61 3 93427695 |
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Email:
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mark.rosenthal@mh.org.au |
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Affiliation:
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Name:
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Professor Mark Rosenthal |
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Address:
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Department of Medical Oncology
Royal Melbourne Hospital
Grattan Street
VIC 3050, Australia
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Telephone:
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+61 3 93427695 |
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Email:
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mark.rosenthal@mh.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion: Newly diagnosed glioblastoma, performance status 0-2, completed post-operative concurrent radiotherapy/chemotherapy.
Exclusion criteria: Exclusion: significant co-morbidities
Age minimum:
18 Years
Age maximum:
0 Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Glioblastoma
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Intervention(s)
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Phase II Trial of six months of oral Temozolomide (200mg/m2 days 1-5, q4 weekly) and intravenous liposomal doxorubicin (40mg/m2 q 4 weekly) (Caelyx) in standard doses in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy to improve six month progression free survival.
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Primary Outcome(s)
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Six month progression free survival following commencement of therapy.
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Secondary Outcome(s)
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Toxicity
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Source(s) of Monetary Support
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Schering-Plough
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