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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Universitätsmedizin Mannheim
Mannheim, Germany
RECRUITINGMedian local progression-free-survival
Rate of recurrence of the treated lesion in the brain
Time frame: 2 years
Overall-survival
Survival differentiated between death due to systemic cancer progress and death due to cerebral progress
Time frame: 5 years
Time to further therapy
Time to further cancer therapy (e.g. salvage chemotherapy)
Time frame: 6 month
Patients cognitive performance
Neuropsychological battery
Time frame: 5 years
Patients quality of life
Patient questionary
Time frame: 5 years
Global progression-free-survival
Systemic cancer progression-free-survival
Time frame: 2 years
Regional progression-free-survival
Progression-free survival concerning other brain metastases
Time frame: 2 years
Intraoperative radiotherapy caused dose-limiting toxicities
Occurrence of wound healing disorders or infection requiring surgical revision, cerebral bleeding or ischemia, radionecrosis requiring surgical intervention
Time frame: 6 month after intervention
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