Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)
- Registration Number
- NCT00725010
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Participant sampling method: consecutive patient sampling.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Newly diagnosed Glioblastoma multiforme
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Exclusion Criteria
- History of hypersensitivity to temozolomide or its components, or to dacarbazine.
- Women who are pregnant or breast-feeding.
- Patients with severe myelosuppression.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Radiotherapy Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care. Patients Temozolomide Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.
- Primary Outcome Measures
Name Time Method Safety: Number of Adverse Events in the Indicated Categories Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase Number of Participants Who Discontinued Due to Toxicity Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
- Secondary Outcome Measures
Name Time Method