CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Temozolomide +1 moredrug
Likely dose
Temozolomide 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00725010
NCT00725010N/ACompleted
CompareCT.gov

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

Merck Sharp & Dohme LLC·observational·Posted Jul 30, 2008·Updated Sep 9, 2015

In Brief

An observational study evaluating Temozolomide and Radiotherapy for Glioblastoma. Completed, enrolled 64 participants.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 30, 2008
Enrollment StartApr 1, 2007
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.9 years ago

Interventions

Temozolomidedrug

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.

Radiotherapyradiation

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.