IORT After Surgical Resection of Brain Metastases

Brain Neoplasms Clinical Trial

— IORT_BRAINM1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084092
• Other study ID #: IORT_BRAIN_MET_2019
• Status: Recruiting
• Phase: Phase 2
• Start date: June 17, 2020
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: Institut Català d'Oncologia
• Contact: Miquel Macià, MD
• Phone: +34 93 260 77 20
• Email: mmacia[@]iconcologia.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Spain	Catalan Institute of Oncology	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Català d'Oncologia

Country where clinical trial is conducted

Spain, 

Outcome

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