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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00087308 |
Purpose
RATIONALE: Assessing urine and blood levels of certain proteins may help identify patients who will have a recurrence of glioblastoma multiforme.
PURPOSE: This clinical trial is studying how well assessing urine and blood protein levels works in predicting 1-year recurrence of disease in patients who are undergoing radiation therapy for glioblastoma multiforme.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors |
Procedure: laboratory biomarker analysis Procedure: radiation therapy |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Open Label |
| Official Title: | Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence |
| Estimated Enrollment: | 130 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are stratified according to age, Karnofsky performance status, extent of resection, and neurological function.
Within 6 weeks after surgical resection, patients undergo standard radiotherapy once daily, 5 days a week, for 6 weeks.
Blood and urine samples are collected at baseline, approximately halfway through radiotherapy, at the completion of radiotherapy, and then at 1 month and 1 year after the completion of radiotherapy to measure vascular endothelial growth factor and matrix metalloproteinase levels.
Patients are followed at 1 and 12 months.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 150 Study Locations| Study Chair: | Kevin Camphausen, MD | NCI - Radiation Oncology Branch; ROB |
More Information
| Study ID Numbers: | CDR0000373891, RTOG-0611, NCI-04-C-0200 |
| Study First Received: | July 8, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00087308 |
| Health Authority: | United States: Federal Government |
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
|
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Central Nervous System Neoplasms Gliosarcoma Recurrence Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |
