Status:
COMPLETED
Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00704808
Start Date
May 1 2006
End Date
December 1 2008
Last Update
September 9 2015
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