Status:
COMPLETED
Pegylated Liposomal Doxorubicine and Prolonged Temozolomide in Addition to Radiotherapy in Newly Diagnosed Glioblastoma
Lead Sponsor:
University of Regensburg
Collaborating Sponsors:
Essex Pharma Germany
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Glioblastomas represent 40% of all tumors of the central nervous system (CNS) and are among the most lethal tumors. Temozolomide (TMZ) combined with radiotherapy was the first substance to significant...
Eligibility Criteria
Inclusion
- newly diagnosed glioblastoma
- centrally confirmed histology
- Karnofsky performance score (KPS) \> 70%
- stable corticosteroids within 2 weeks before inclusion
- leucocytes \> 3/ul, thrombocytes \> 100/ul, Hb \> 10 g/dl
- additional standard criteria
Exclusion
- other tumor in history
- pretreatment with radiotherapy to the brain
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00944801
Start Date
July 1 2002
End Date
May 1 2009
Last Update
July 23 2009
Active Locations (1)
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1
University of Regensburg, Department of Neurology
Regensburg, Germany, 93053