Clinical trial · Interventional
Preoperative Chemoradiation for Glioblastoma
Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma
NCT02092038CI-TRIAL-00019743completedPhase 1ClinicalTrials.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)
Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further 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 |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| craniotomy and tumor resection | Procedure | — | UNRESOLVED |
| partial brain irradiation | Radiation | — | UNRESOLVED |
| stereotactic biopsy of brain tumor | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperative chemoradiation
- description
- Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide
- interventionNames
- Drug: Temozolomide
- Radiation: partial brain irradiation
- Procedure: stereotactic biopsy of brain tumor
- Procedure: craniotomy and tumor resection
Primary outcomes (1)
- measure
- toxicity of treatment per Common Toxicity Criteria for Adverse Effects V3.0
- timeFrame
- up to up to 16 weeks
- description
- comparison of toxicity related to experimental treatment to historical local controls
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * MRI lesions of the brain that have a high probability of being glioblastoma in a potentially resectable location in the brain (the primary study population) * WHO performance status 0-2 (to allow comparison to historical controls) * Adequate hematological parameters: (for safety because of neutropenia from the temozolomide) * Consent can be obtained from the patient, and if the patient cannot give consent then from the medical power of attorney and if one is not assigned, then the nearest relative (required to obtain consent) * Able to have MRI scans (secondary endpoint is MRI scan characteristics) * Willing to have radiation treatment at a participating center (homogeneity of treatment parameters) * Ages 18-80 Exclusion Criteria: * Unresectable tumor * Absolute neutrophil count (ANC) less than 1,200/μL * Hemoglobin less than 9.0g/dL * Platelet count less than 100,000/μL
References
Publications (0)
Data not yet available
No reference posted for this study.