Clinical trial · Interventional
Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform
A Phase 1-2 Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme
NCT01120639CI-TRIAL-00053140Tx-TreatmentcompletedPhase 1 / Phase 2Results 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 study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Brain and Nervous System | — | UNRESOLVED | — |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiosurgery (SRS) | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiosurgery (25 Gray x 5 fractions)+Temozolomide
- description
- Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
- interventionNames
- Drug: Temozolomide
- Procedure: Stereotactic Radiosurgery (SRS)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiosurgery (30 Gray x 5 fractions)+Temozolomide
- description
- Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.
- interventionNames
- Drug: Temozolomide
- Procedure: Stereotactic Radiosurgery (SRS)
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision * The tumor must be supratentorial in location * The planning target volume (tumor plus margin) must measure ≤ 150 cm\^3 in volume * Age ≥ 18 years * Life expectancy of at least 12 weeks * Patient must have adequate organ function to tolerate temozolomide (details in the protocol) Exclusion Criteria: * Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields * Tumor foci detected below the tentorium * Multifocal disease or leptomeningeal spread * Prior allergic reaction to the study drugs involved in this protocol * Patients with pacemaker will be allowed to undergo CT instead of MRI * Pediatric patients (age \< 18), pregnant women, and nursing patients will be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.