Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)

Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme

The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.

Inclusion Criteria:

• Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor <=1.5 cm by magnetic resonance imaging (MRI).
• Age >=18 years.
• Hemoglobin >=10 g/dL.
• White blood cell count >=1.5x10^9/L.
• Platelet count >=100x10^9/L.
• Blood urea <=1.5 x upper limit of normal values (ULN).
• Creatinine <=1.5 x ULN.
• Bilirubin <=1.5 x ULN.
• Aspartate aminotransferase <=3 x ULN.
• Alanine aminotransferase <=3 x ULN.
• Alkaline phosphatase <=2 x ULN.

Exclusion Criteria:

• Tumor-specific pretreatment.
• Contraindication against radiotherapy and/or chemotherapy.
• Malignomas other than basaliomas.
• Existing or planned pregnancy or lactation or inadequate contraception.
• Psychiatric disease.
• Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.