At a glance
ClinicalIndex Comparison RecordN/ACompleted· 180 enrolled
Drug / intervention
Temozolomide +2 moredrug
Likely dose
Not stated in 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.
Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme
In Brief
An observational study evaluating Primary surgical treatment, Radiotherapy, and 1 other intervention for Glioblastoma. Completed, enrolled 180 participants.
Detailed Summary
The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
Countries--
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedJun 2008
Primary CompletionDec 2008
TodayJul 2026
First PostedJun 25, 2008
Enrollment StartMay 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.0 years ago
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.