Clinical trial · Interventional
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion
NCT00283543CI-TRIAL-00000933unknownPhase 2ClinicalTrials.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)
To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide
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 |
|---|---|---|---|
| Newly Diagnosed Supratentorial Malignant Glioma | Glioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gliadel Wafer | Drug | Carmustine | ALIAS |
| Limited field radiation | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the safety and efficacy of Gliadel 3.85% wafers
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * MRI showing unilateral supratentorial cerebral tumor * surgical tx within 4 weeks of baseline MRI * KPS 60% or higher * moderate to high grade malignant glioma Exclusion Criteria: * prior cytoreductive surgery for moderate or high grade glioma * prior CNS radiotherapy * prior chemo for this glioma * more than one focus of tumor or tumor crossing the midline per MRI * life expectancy less than 12 months * sensitivity to temozolomide, nitrosoureas, or Gliadel wafer
References
Publications (0)
Data not yet available
No reference posted for this study.