Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)

The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.

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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

Sex eligibility

All sexes

Study type

Observational

About this study

Participant sampling method: consecutive patient sampling.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Newly diagnosed Glioblastoma multiforme

Exclusion criteria

History of hypersensitivity to temozolomide or its components, or to dacarbazine.
Women who are pregnant or breast-feeding.
Patients with severe myelosuppression.

Treatment and study plan

Temozolomide

Drug

Temozolomide will be administered orally at 75 mg/m^2 with radiotherapy during the concomitant treatment phase. After four weeks, temozolomide will be administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase.

Other names: Temodal, Temodar, SCH 052365

Radiotherapy

Radiation

Radiotherapy will consist of fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.

Other names: Radiation therapy, Irradiation

Primary outcomes

Safety: Number of Adverse Events in the Indicated Categories

Time frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
Number of Participants Who Discontinued Due to Toxicity

Time frame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jul 30, 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