Intraoperative Radiotherapy After the Resection of Brain Metastases (INTRAMET)

Universitätsmedizin Mannheim

Status: Enrolling

Conditions: Brain Metastases

Treatments: Radiation: Intraoperative Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03226483

2016-638N-MA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intraoperative radiotherapy

Experimental group

Description:

After neurosurgical resection and proven metastasis (frozen section) a local intraoperative radiotherapy with soft energy x-rays is applied to the resection cavity. To perform this an applicator is inserted into the situs in the tightest fit rule. The highest possible dose between 30-20 Gy is chosen depending on nearby risk structures (Optic nerve, brainstem) is prescribed. After radiotherapy the applicator is removed and the surgery will be finished in standard way.

Treatment:

Radiation: Intraoperative Radiotherapy