Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Glioblastoma
Both
Glioblastoma
Trial Information
Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme
Outcome Time Frame:
After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide
Safety Issue:
No
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
P04739
NCT ID:
NCT00704808
Start Date:
May 2006
Completion Date:
December 2008
Related Keywords:
- Glioblastoma
- Glioblastoma
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