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Urine and Blood Protein Levels in Predicting One-Year Recurrence of Glioblastoma Multiforme in Patients Undergoing Radiation Therapy
This study is ongoing, but not recruiting participants.
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

MedlinePlus related topics: Cancer Urine and Urination
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 130
Study Start Date: February 2006
Estimated Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether an increase in urinary and serum levels of vascular endothelial growth factor and matrix metalloproteinases from the end of treatment to the 1-month follow-up is predictive of 1-year disease recurrence in patients with glioblastoma multiforme undergoing radiotherapy.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed supratentorial glioblastoma multiforme
  • Candidate for radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • HIV negative
  • No other malignancy except nonmelanoma skin cancer or carcinoma in situ

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior gliadel wafer placement
  • Concurrent chemotherapy allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy to the brain

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087308

  Show 150 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Kevin Camphausen, MD NCI - Radiation Oncology Branch; ROB
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009