Clinical trial · Interventional
Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma
NCT03055208CI-TRIAL-00066374Gamma-GBMsuspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): suspended due to low accrual rates
Summary
Brief summary (as posted)
Gamma GBM is a single-arm phase II trial that prospectively measures the progression-free survival time after addition of an early gamma knife boost to areas of residual tumor to standard-of-care (surgery, chemo-radiotherapy, chemotherapy).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gamma knife radiosurgery (15 Gy to 50% isodose) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiosurgery
- description
- Following intraoperative confirmation of glioblastoma (frozen section): Early (24-72h post surgery) stereotactic ablation (gamma knife radiosurgery) of residual tumor (defined in early postoperative T1-weighted MRI scanning with and without contrast), followed by standard-of-care therapy (chemo-radiotherapy with 60 Gy external beam radiation therapy (EBRT) and 75 mg/m2/d temozolomide, followed by adjuvant chemotherapy with 150-200 mg/m2/d/cycle temozolomide in a 5/28 days schedule).
- interventionNames
- Radiation: gamma knife radiosurgery (15 Gy to 50% isodose)
Primary outcomes (1)
- measure
- Median Progression-Free Survival Time (PFS)
- timeFrame
- 2 years
- description
- PFS is defined as the time span of initial diagnosis (i.e., the day of surgery) until tumor progression is confirmed in follow-up MRI scans. All scans will be assessed using modified Response Assessment in Neuro-Oncology (RANO) criteria or until death by any cause.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * Karnofsky performance status score ≥ 60 * histology must be glioblastoma (frozen sections during surgery) * radiographic proof of residual tumor * Informed consent * adequate birth control (e.g., oral contraceptives) Exclusion Criteria: * any previous cranial radiotherapy * histology inconclusive or low(er)-grade astrocytoma * contraindications for chemo- or radiotherapy * bleeding or clotting disorders * contraindications for MRI or CT scans
References
Publications (0)
Data not yet available
No reference posted for this study.