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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05084092
Other study ID # IORT_BRAIN_MET_2019
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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