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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Glioblastoma

Treatments: Radiation: Radiotherapy; Procedure: Primary surgical treatment; Drug: Temozolomide

Study type: Observational

Funder types: Industry

Identifiers

NCT00704808

P04739

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

180 participants in 1 patient group

Patients

Description:

Patients with newly diagnosed and operated glioblastoma multiforme.

Treatment:

Drug: Temozolomide

Procedure: Primary surgical treatment

Radiation: Radiotherapy