IORT After Surgical Resection of Brain Metastases (IORT_BRAINM1)

Institut Català d'Oncologia

Status and phase: Enrolling; Phase 2

Conditions: Brain Neoplasms

Treatments: Procedure: Brain surgery; Radiation: Intraoperative Radiotherapy (IORT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05084092

IORT_BRAIN_MET_2019

Details and patient eligibility

About

To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years, Karnofsky Performance Index ≥ 70.
• Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1- weighted MRI scan) amenable to total resection with no dural attachment.
• Frozen section confirming a metastasis of an extracranial (i.e. non-CNS) tumor.
• Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy).
• Adequate birth control.
• Informed consent.

Exclusion criteria

• Leptomeningeal spread and dural attachment (assessed pre- and intraoperative).
• Frozen section reveals primary CNS tumor, lymphoma, SCLC or germinoma.
• Psychiatric or social condition potentially interfering with compliance.
• Contraindication against anesthesia, surgery, MRI and/or contrast agents.
• 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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40 participants in 1 patient group

Intraoperative Radiotherapy (IORT)

Experimental group

Description:

Intraoperative Radiotherapy (IORT) administered during surgery

Treatment:

Procedure: Brain surgery

Radiation: Intraoperative Radiotherapy (IORT)