IORT After Surgical Resection of Brain Metastases (IORT_BRAINM1)

IORT After Surgical Resection of Brain Metastases: Feasibility and Efficacy Phase II Trial

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 Overview

• Status: Recruiting
• Conditions: Brain Neoplasms
• Intervention / Treatment: Radiation: Intraoperative Radiotherapy (IORT); Procedure: Brain surgery

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Miquel Macià, MD; Phone Number: +34 93 260 77 20; Email: mmacia@iconcologia.net

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Recruiting
      • Catalan Institute of Oncology
      • Contact: Miquel Macià, MD; Phone Number: +34 93 260 77 20; Email: mmacia@iconcologia.net
      • Contact: Anna Lucas, MD; Phone Number: +34 93 260 77 20; Email: alucas@iconcologia.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intraoperative Radiotherapy (IORT); Intraoperative Radiotherapy (IORT) administered during surgery

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	12 months
Median overall survival (OS)	Time (in months) from surgery of brain metastases to death by any cause	12 months
Change in neurocognitive performance (compared to baseline): Minimental	Assessed by minimal mental scale examination	6, and 12 months
Change in neurocognitive performance (compared to baseline): Trail making	Assessed by trail making test	6, and 12 months
Change in neurocognitive performance (compared to baseline): Repetition	Assessed by number repetition test (forward and backward)	6, and 12 months
Change in neurocognitive performance (compared to baseline): Oral	Assessed by controlled oral word association test	6, and 12 months
Change in neurocognitive performance (compared to baseline): Semantic	Assessed by semantic word association	6, and 12 months
Quality of life (QoL)	Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)	6, and 12 months
Radiation-related (acute / early delayed / late) neurotoxicity	Assessed by regular neurological examinations combined by serial MRI scans	12 months

Collaborators and Investigators

• Sponsor: Institut Català d'Oncologia
• Investigators: Principal Investigator: Miquel Macià, MD, Institut Catala d'Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: neurosurgery; intraoperative radiotherapy; Brain metastases; local therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: IORT_BRAIN_MET_2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No