| Title: | A Phase III trial comparing the standard dose of temozolomide with a more increased, longer lasting dose of temozlomide in patients with newly diagnosed glioblastoma |
| Purpose: | The purpose of this study is to determine whether increasing the duration of temozolomide treatment after radiation from five days out of 28 days (standard-dose schedule) to 21 days out of 28 days (dose-dense schedule) will further improve results. |
| Study Number: | 108814 |
| Number of Patients: | 834 |
| Elgibility: |
Patients must have a pathology-proven diagnosis of glioblastoma multiforme, with a diagnosis made by a surgical biopsy or excision. Treatment must begin within five weeks of surgery. A CT scan or MRI pre- and post- operatively must be completed.
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| Treatment: | Standard-dose temozolomide will start on the first day of radiation treatments. You will take the temozolomide orally once daily continuously (seven days a week) for a maximum of seven weeks. You will receive radiation Monday through Friday for a total of 30 radiation treatments. After the radiation is completed, you will be randomized by a computer to either group 1 (the standard dose schedule) or group 2 (dose-dense schedule). |
| Principal Investigator: |
Edward Melian, M.D. |
| Enrollment Phone: | (708) 216-2568 |
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