Clinical trial · Interventional
Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme
- 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)
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together with radiation therapy works in treating patients with glioblastoma multiforme.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival After Treatment
- timeFrame
- Minimum of 5 years.
- description
- Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed grade IV malignant glioblastoma multiforme
* Diagnosis by surgical biopsy or resection within the past 5 weeks
* Post-operative diagnostic contrast-enhanced MRI scan with MR spectroscopy must be performed prior to initiating study treatment
* High-risk area of active tumor without margin by MR spectroscopy
* Meets the following criteria for radiosurgery:
* Maximum diameter ≤ 40 mm
* Located \> 5 mm from the optic nerve or chiasm
* Does not involve the brainstem
* No multifocal or recurrent malignant glioma
PATIENT CHARACTERISTICS:
Performance status
* Karnofsky 50-100%
Life expectancy
* At least 3 months
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Not pregnant
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Chemotherapy
* At least 6 weeks since chemotherapy
* Concurrent chemotherapy allowed
Endocrine therapy
* Concurrent steroids allowed, but at the smallest therapeutic dose possible
Radiotherapy
* No prior in-field radiotherapy to the head and neck
Surgery
* See Disease Characteristics
* Recovered from prior surgery or any post-operative complication
Other
* Concurrent antiseizure medications allowedReferences
Publications (1)
- DERIVEDEinstein DB, Wessels B, Bangert B, Fu P, Nelson AD, Cohen M, Sagar S, Lewin J, Sloan A, Zheng Y, Williams J, Colussi V, Vinkler R, Maciunas R. Phase II trial of radiosurgery to magnetic resonance spectroscopy-defined high-risk tumor volumes in patients with glioblastoma multiforme. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):668-74. doi: 10.1016/j.ijrobp.2012.01.020. Epub 2012 Mar 22. PMID 22445005