IORT After Surgical Resection of Brain Metastases

Institut Català d'Oncologia40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Neoplasms

Interventions

Intraoperative Radiotherapy (IORT)RADIATION

If biopsy is positive, local treatment with IORT will be performed. After IORT (15,40 Gray at 2 mm dept), the applicator will be removed and surgery will be continued in a standard fashion.

Brain surgeryPROCEDURE

Surgery should be performed according to the local standard of care, preferentially as image-(neuronavigation) guided surgery. To establish the diagnosis of a metastasis and to exclude primary CNS tumors, lymphomas, SCLCs or germinomas it will be performed a peroperative biopsy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Catalan Institute of Oncology

L'Hospitalet de Llobregat, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Median local progression free survival (PFS)

Time span (in months) between surgery and recurrence within a 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.

Time frame: 12 months

Secondary Outcomes

Median regional PFS (rPFS)

The time (in months) from surgery to any progression outside of the 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.

Time frame: 12 months

Global PFS (gPFS)

Time (in months) from surgery to any intra- and extracranial tumor progression evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.

Time frame: 12 months

Median time to the initiation of systemic therapies

Time (in days) from surgery to the day of initiation of any systemic anti-tumor therapy (e.g., chemotherapy)

Time frame: 12 months

Median overall survival (OS)

Time (in months) from surgery of brain metastases to death by any cause

Time frame: 12 months

Change in neurocognitive performance (compared to baseline): Minimental

Assessed by minimal mental scale examination

Time frame: 6, and 12 months

Change in neurocognitive performance (compared to baseline): Trail making

Central Contacts

Miquel Macià, MD

CONTACT

+34 93 260 77 20 mmacia@iconcologia.net

Data from ClinicalTrials.gov

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