Clinical trial NCT03226483: Intraoperative Radiotherapy After the Resection of Brain Metastases
Official title: Intraoperative Radiotherapy After the Resection of Brain Metastases - a Phase II Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Metastases
Keywords: Brain Metastases
Intraoperative Radiotherapy
Neurosurgery
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Median local progression-free-survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall-survival
timeFrame: 5 years
measure: Time to further therapy
timeFrame: 6 month
measure: Patients cognitive performance
timeFrame: 5 years
measure: Patients quality of life
timeFrame: 5 years
measure: Global progression-free-survival
timeFrame: 2 years
measure: Regional progression-free-survival
timeFrame: 2 years
measure: Intraoperative radiotherapy caused dose-limiting toxicities
timeFrame: 6 month after intervention
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Stefanie Brehmer, MD
role: PRINCIPAL_INVESTIGATOR
References: