Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)(COMPLETED)
The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program|
- Safety: Number of Adverse Events in the Indicated Categories [ Time Frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase ] [ Designated as safety issue: Yes ]
- Number of Participants Who Discontinued Due to Toxicity [ Time Frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.
Temozolomide will be administered orally at 75 mg/m^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.
Other Names:Radiation: Radiotherapy
Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
Participant sampling method: consecutive patient sampling.