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IORT After Surgical Resection of Brain Metastases (IORT_BRAINM1)

Primary Purpose

Brain Neoplasms

Status

Recruiting

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Intraoperative Radiotherapy (IORT)

Brain surgery

About this trial

This is an interventional treatment trial for Brain Neoplasms focused on measuring Brain metastases, neurosurgery, intraoperative radiotherapy, local therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Catalan Institute of OncologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative Radiotherapy (IORT)

Arm Description

Intraoperative Radiotherapy (IORT) administered during surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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)

Median overall survival (OS)

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

Change in neurocognitive performance (compared to baseline): Minimental

Assessed by minimal mental scale examination

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

Assessed by trail making test

Change in neurocognitive performance (compared to baseline): Repetition

Assessed by number repetition test (forward and backward)

Change in neurocognitive performance (compared to baseline): Oral

Assessed by controlled oral word association test

Change in neurocognitive performance (compared to baseline): Semantic

Assessed by semantic word association

Quality of life (QoL)

Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)

Radiation-related (acute / early delayed / late) neurotoxicity

Assessed by regular neurological examinations combined by serial MRI scans

Full Information

NCT ID

NCT05084092

First Posted

April 8, 2021

Last Updated

August 2, 2022

Sponsor

Institut Català d'Oncologia

1. Study Identification

Unique Protocol Identification Number

NCT05084092

Brief Title

IORT After Surgical Resection of Brain Metastases

Acronym

IORT_BRAINM1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 17, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Català d'Oncologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Neoplasms

Keywords

Brain metastases, neurosurgery, intraoperative radiotherapy, local therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Intraoperative Radiation Therapy (IORT)

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intraoperative Radiotherapy (IORT)

Arm Type

Experimental

Arm Description

Intraoperative Radiotherapy (IORT) administered during surgery

Intervention Type

Radiation

Intervention Name(s)

Intraoperative Radiotherapy (IORT)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Brain surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

Median local progression free survival (PFS)

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Median regional PFS (rPFS)

Description

Time Frame

12 months

Title

Global PFS (gPFS)

Description

Time Frame

12 months

Title

Median time to the initiation of systemic therapies

Description

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

Time Frame

12 months

Title

Median overall survival (OS)

Description

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

Time Frame

12 months

Title

Change in neurocognitive performance (compared to baseline): Minimental

Description

Assessed by minimal mental scale examination

Time Frame

6, and 12 months

Title

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

Description

Assessed by trail making test

Time Frame

6, and 12 months

Title

Change in neurocognitive performance (compared to baseline): Repetition

Description

Assessed by number repetition test (forward and backward)

Time Frame

6, and 12 months

Title

Change in neurocognitive performance (compared to baseline): Oral

Description

Assessed by controlled oral word association test

Time Frame

6, and 12 months

Title

Change in neurocognitive performance (compared to baseline): Semantic

Description

Assessed by semantic word association

Time Frame

6, and 12 months

Title

Quality of life (QoL)

Description

Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)

Time Frame

6, and 12 months

Title

Radiation-related (acute / early delayed / late) neurotoxicity

Description

Assessed by regular neurological examinations combined by serial MRI scans

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miquel Macià, MD

Phone

+34 93 260 77 20

mmacia@iconcologia.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miquel Macià, MD

Organizational Affiliation

Institut Català d'Oncologia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Catalan Institute of Oncology

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08908

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miquel Macià, MD

Phone

+34 93 260 77 20

mmacia@iconcologia.net

First Name & Middle Initial & Last Name & Degree

Anna Lucas, MD

Phone

+34 93 260 77 20

alucas@iconcologia.net

12. IPD Sharing Statement

Learn more about this trial

IORT After Surgical Resection of Brain Metastases

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