IORT_BRAINM1: IORT After Surgical Resection of Brain Metastases

Sponsor

Institut Català d'Oncologia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05084092

Collaborator

(none)

Enrollment

Location

Arm

53.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Brain Neoplasms	Radiation: Intraoperative Radiotherapy (IORT) Procedure: Brain surgery	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Intraoperative Radiation Therapy (IORT)Intraoperative Radiation Therapy (IORT)

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 17, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Median local progression free survival (PFS) [12 months]
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) [12 months]
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) [12 months]
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 [12 months]
Time (in days) from surgery to the day of initiation of any systemic anti-tumor therapy (e.g., chemotherapy)
Median overall survival (OS) [12 months]
Time (in months) from surgery of brain metastases to death by any cause
Change in neurocognitive performance (compared to baseline): Minimental [6, and 12 months]
Assessed by minimal mental scale examination
Change in neurocognitive performance (compared to baseline): Trail making [6, and 12 months]
Assessed by trail making test
Change in neurocognitive performance (compared to baseline): Repetition [6, and 12 months]
Assessed by number repetition test (forward and backward)
Change in neurocognitive performance (compared to baseline): Oral [6, and 12 months]
Assessed by controlled oral word association test
Change in neurocognitive performance (compared to baseline): Semantic [6, and 12 months]
Assessed by semantic word association
Quality of life (QoL) [6, and 12 months]
Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)
Radiation-related (acute / early delayed / late) neurotoxicity [12 months]
Assessed by regular neurological examinations combined by serial MRI scans

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.