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Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Kentuckiana Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
Kentuckiana Cancer Institute
ClinicalTrials.gov Identifier:
NCT00283543
First received: January 26, 2006
Last updated: October 30, 2007
Last verified: October 2007
History of Changes

January 26, 2006
October 30, 2007
September 2002
Not Provided
To determine the safety and efficacy of Gliadel 3.85% wafers
Same as current
Complete list of historical versions of study NCT00283543 on ClinicalTrials.gov Archive Site
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Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion

To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Newly Diagnosed Supratentorial Malignant Glioma
  • Drug: Gliadel Wafer
  • Drug: Temozolomide
  • Procedure: Limited field radiation
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
April 2008
Not Provided

Inclusion Criteria:

  • MRI showing unilateral supratentorial cerebral tumor
  • surgical tx within 4 weeks of baseline MRI
  • KPS 60% or higher
  • moderate to high grade malignant glioma

Exclusion Criteria:

  • prior cytoreductive surgery for moderate or high grade glioma
  • prior CNS radiotherapy
  • prior chemo for this glioma
  • more than one focus of tumor or tumor crossing the midline per MRI
  • life expectancy less than 12 months
  • sensitivity to temozolomide, nitrosoureas, or Gliadel wafer
Both
18 Years to 72 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283543
1068016, 128-02
Not Provided
Not Provided
Kentuckiana Cancer Institute
Eisai Inc.
Study Director: Renato V. LaRocca, MD Kentuckiana Cancer Institute
Kentuckiana Cancer Institute
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP