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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00790452 |
Primary objective:
To determine whether aspirin (ASA) can lower the incidence of Venous Thromboembolism(VTE) in patients with Glioblastoma (GBM).
Secondary objectives:
To determine clinical and laboratory factors which are associated with increased risk of VTE
If it is determined that ASA reduces the incidence of VTE in patients with GBM, then to determine the clinical and laboratory factors which are associated with an increased benefit from the drug.
Condition | Intervention | Phase |
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Glioblastoma |
Drug: Aspirin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase II Trial of Aspirin for Primary Prophylaxis of Venous Thromboembolism in Glioblastoma |
Estimated Enrollment: | 224 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator
Aspirin
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Drug: Aspirin
325mg daily by mouth
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Group 2: Active Comparator
Placebo
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Drug: Placebo
Tablet daily by mouth
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
White, not of Hispanic Origin - 88%. Other or Unknown - 2%. Total-100%
Contact: Victor A Levin, MD,BS | 713-792-2883 |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 |
Principal Investigator: | Victor A Levin, MD,BS | The University of Texas MD Anderson Cancer |
Responsible Party: | UT MD Anderson Cancer Center ( Victor Levin, MD/ BS/Professor ) |
Study ID Numbers: | 2007-0266 |
Study First Received: | November 7, 2008 |
Last Updated: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00790452 History of Changes |
Health Authority: | United States: Institutional Review Board |
Brain Hematologic Disorder Venous Thromboembolism Glioblastoma Aspirin |
Placebo VTE ASA DVT |
Anti-Inflammatory Agents Glioblastoma Fibrinolytic Agents Thromboembolism Fibrin Modulating Agents Aspirin Neoplasms, Germ Cell and Embryonal Neuroepithelioma Anti-Inflammatory Agents, Non-Steroidal Glioma Analgesics Astrocytoma Hematologic Diseases |
Cyclooxygenase Inhibitors Vascular Diseases Cardiovascular Agents Venous Thromboembolism Thrombosis Neuroectodermal Tumors Embolism and Thrombosis Embolism Analgesics, Non-Narcotic Platelet Aggregation Inhibitors Peripheral Nervous System Agents Antirheumatic Agents Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Glioblastoma Molecular Mechanisms of Pharmacological Action Hematologic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Fibrinolytic Agents Thromboembolism Fibrin Modulating Agents Aspirin Sensory System Agents Therapeutic Uses Neoplasms, Germ Cell and Embryonal Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal |
Glioma Analgesics Neoplasms by Histologic Type Astrocytoma Cyclooxygenase Inhibitors Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Venous Thromboembolism Thrombosis Pharmacologic Actions Neuroectodermal Tumors Embolism and Thrombosis Neoplasms Analgesics, Non-Narcotic |