IORT After Surgical Resection of Brain Metastases

NCT05084092 | Unknown Phase 2

• 1 other identifier: IORT_BRAIN_MET_2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Neoplasms

Keywords

Brain metastases; neurosurgery; intraoperative radiotherapy; local therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (11)

• Median regional PFS (rPFS)

  12 months

• Global PFS (gPFS)

  12 months

• Median time to the initiation of systemic therapies

  12 months

• Median overall survival (OS)

  12 months

• Change in neurocognitive performance (compared to baseline): Minimental

  6, and 12 months

Study Arms (1)

Intraoperative Radiotherapy (IORT)

EXPERIMENTAL

Intraoperative Radiotherapy (IORT) administered during surgery

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

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.

Intraoperative Radiotherapy (IORT)

Brain surgery PROCEDURE

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

Intraoperative Radiotherapy (IORT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead

Study Sites (1)

Catalan Institute of Oncology

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Miquel Macià, MD

  Institut Català d'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miquel Macià, MD

CONTACT

+34 93 260 77 20; mmacia@iconcologia.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intraoperative Radiation Therapy (IORT)

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: October 19, 2021
• Study Start: June 17, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

ES (1)