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

Merck Sharp & Dohme LLC180 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Glioblastoma

Interventions

Primary surgical treatmentPROCEDURE

Primary surgery for tumor resection.

RadiotherapyRADIATION

Radiotherapy is given with concomitant temozolomide. Dosing according to European Summary of Product Characteristics.

TemozolomideDRUG

Temozolomide is first given with concomitant radiotherapy, and then as monotherapy (adjuvant chemotherapy). Dosing according to European Summary of Product Characteristics.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme

Time frame: After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.