Clinical trial · Observational
Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme
NCT00704808CI-TRIAL-00019070completedResults 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 surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary surgical treatment | Procedure | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- Patients with newly diagnosed and operated glioblastoma multiforme.
- interventionNames
- Procedure: Primary surgical treatment
- Radiation: Radiotherapy
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme
- timeFrame
- After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.