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

Completed

• Conditions: Glioblastoma
• Interventions: Procedure: Primary surgical treatment; Radiation: Radiotherapy; Drug: Temozolomide

• Registration Number: NCT00704808
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2010-03-17
• Results First Submitted QC: 2010-03-17
• Results First Posted: 2010-04-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Temozolomide	Patients with newly diagnosed and operated glioblastoma multiforme.
Patients	Primary surgical treatment	Patients with newly diagnosed and operated glioblastoma multiforme.
Patients	Radiotherapy	Patients with newly diagnosed and operated glioblastoma multiforme.

Primary Outcome Measures

Name	Time	Method
Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme	After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide