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

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

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary surgical treatment

Procedure

Primary surgery for tumor resection.

Other names: Resection, Operation, Surgery

Radiotherapy

Radiation

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

Other names: Irradiation, Radiation therapy

Temozolomide

Drug

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

Other names: Temodal, Temodar, SCH 052365

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jun 25, 2008
Registry last updated: Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed