Clinical trial · Observational
Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)
Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program
NCT00725010CI-TRIAL-00019080completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- Participants with newly diagnosed Glioblastoma multiforme who were prescribed temozolomide and radiotherapy as standard care.
- interventionNames
- Drug: Temozolomide
- Radiation: Radiotherapy
Primary outcomes (2)
- measure
- Safety: Number of Adverse Events in the Indicated Categories
- timeFrame
- Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
- measure
- Number of Participants Who Discontinued Due to Toxicity
- timeFrame
- Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.