Glioblastoma
Conditions
Keywords
Glioblastoma, Radiosurgery, Gamma Knife
Brief summary
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).
Detailed description
Glioblastomas are highly malignant brain tumors that recur about 6 months after treatment. Most recurrences develop at the edge of the surgical margin and a common reason for an early recurrence of a glioblastoma is when tumors are not completely resected. This may be the case when intraoperative neuro-monitoring indicates that further resection would impair certain motor functions. Physicians can identify residual tumor in early (24-72h after surgery) postoperative MRI scans and could treat these regions. However, this treatment would not be a part of the recommended standard of care and thus, any further treatment of this areas will need a clinical trial. The aim of this trial is to evaluate if the use of another modality to deplete these areas of residual tumor identified in early postoperative MRI scans will provide a relevant benefit in terms of progression-free survival (which means a prolongation of the time that patients do not experience a re-growth of the tumor). The modality is termed radiosurgery, which is a non-invasive technique to delete cells without using a blade but a highly focused beam of gamma rays. The machine that focusses these rays (like a magnifying glass that can focus light), is called 'gamma knife'. Gamma knife radiosurgery is a safe and effective treatment for a plethora of malignant and benign brain tumors and the technique is used since the 1950s and there has been a continuous improvement of precision and patient comfort up to now.
Interventions
RADIATIONgamma knife radiosurgery (15 Gy to 50% isodose)
Radiosurgery with a gamma knife resembles the application of a precisely focused, high single dose of ionizing irradiation.
Sponsors
Universitätsmedizin Mannheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Progression-Free Survival Time (PFS) | 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Median Overall Survival Time (OS) | 2 years | OS is defined as the time span of initial diagnosis (i.e., the day of surgery) until death by any cause. |
| Radiation-related (acute / early delayed / late) neurotoxicity | 2 years | Assessed by regular neurological examinations |
| Incidence of symptomatic radionecrosis | 2 years | Assessed by serial MRI scans |
Countries
Germany
Outcome results
None listed