Brain Metastases
Conditions
Keywords
Brain Metastases, Intraoperative Radiotherapy, Neurosurgery
Brief summary
INTRAMET examines prospectively the effectiveness of an intraoperative radiotherapy immediate after the surgical resection of brain metastases. Patients won't receive further radiation therapy of the intraoperatively treated lesion.
Detailed description
Brain metastases occur in up to 40% of all patients diagnosed with systemic cancer. Without adjuvant radiotherapy after resection of space occupying lesions local recurrence rates are high. That is why guidelines recommend a cavity boosting with x-rays. External beam radiotherapy can lower the risk of local recurrence but means longer hospitalization, prolongs the time to systemic salvage therapies and bears risks of radionecrosis and leucoencephalopathy with neurological and cognitive decline. A solution for this problem could be onetime intraoperative radiotherapy (IORT) with soft x-rays to sterilize the resection cavity, which may provide both: freedom from local recurrence fast track salvage therapy initiation. INTRAMET is a single institution, open-label, prospective, phase 2 feasibility study for intraoperative radiotherapy immediately following resection of brain metastases. 50 adult patients with resectable not dural brain metastases should be treated in surgery after tumor resection with IORT with 20-30Gy prescribed to the margin of the resection cavity. The highest dose tolerable to surrounding risk structures (N. opticus, brainstem) should be used. With this method, the investigators hope to show similar local control rates to postoperative external beam radiotherapy in line with guideline recommendations with less patient hospitalization and faster start of rescue therapies which could lead to a favorable overall outcome and less cognitive side effects.
Interventions
RADIATIONIntraoperative Radiotherapy
Intraoperative Radiotherapy is performed with a mobile radiation device emitting soft energy x-rays in a spherical way. Different size applicators are available to cover the resection cavity after the tightest fit rule.
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
* Karnofsky Performance index ≥ 50% * MRI T1 Gadolinium enhancing non-dural resectable lesion * Informed consent * Adequate birth control * Frozen section confirms metastasis * Adequate distance to optic nerve and brainstem
Exclusion criteria
* Dural lesions or meningeal carcinomatosis * Frozen section reveals glioma, lymphoma,small cell lung cancer or germinoma * Psychiatric or social condition interfering compliance * Contraindication against anesthesia, surgery, MRI and/or Gadolinium * Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median local progression-free-survival | 2 years | Rate of recurrence of the treated lesion in the brain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall-survival | 5 years | Survival differentiated between death due to systemic cancer progress and death due to cerebral progress |
| Time to further therapy | 6 month | Time to further cancer therapy (e.g. salvage chemotherapy) |
| Patients cognitive performance | 5 years | Neuropsychological battery |
| Regional progression-free-survival | 2 years | Progression-free survival concerning other brain metastases |
| Global progression-free-survival | 2 years | Systemic cancer progression-free-survival |
| Intraoperative radiotherapy caused dose-limiting toxicities | 6 month after intervention | Occurrence of wound healing disorders or infection requiring surgical revision, cerebral bleeding or ischemia, radionecrosis requiring surgical intervention |
| Patients quality of life | 5 years | Patient questionary |
Countries
Germany
Contacts
Primary ContactStefanie Brehmer, MD
Outcome results
None listed