Intraoperative Radiotherapy After the Resection of Brain Metastases

NCT ID: NCT03226483

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2023-12-31

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.

Conditions

Brain Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraoperative radiotherapy

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.

Group Type: EXPERIMENTAL

Intraoperative Radiotherapy

Intervention Type: RADIATION

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.

Interventions

Intraoperative 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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Stefanie Brehmer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefanie Brehmer, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mannheim

Locations

Universitätsmedizin Mannheim

Mannheim, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Stefanie Brehmer, MD

Role: CONTACT

stefanie.brehmer@umm.de

+49 621 383 2750

Facility Contacts

Stefanie Brehmer, MD

Role: primary

stefanie.brehmer@umm.de

+49 621 383 2750

A

Role: backup

Other Identifiers

2016-638N-MA

Identifier Type: -

Identifier Source: org_study_id