Brain NeoplasmsPhase 2IORT_BRAINM1NCT05084092
IORT After Surgical Resection of Brain Metastases
A Phase 2 study testing Intraoperative Radiotherapy (IORT) and Brain surgery in people with Brain Neoplasms, run by Institut Català d'Oncologia at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Intraoperative Radiotherapy (IORT) and Brain surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jun 2020to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Catalan Institute of Oncology
L'Hospitalet de Llobregat, Barcelona, 08908
Miquel Macià, MD, +34 93 260 77 20, mmacia@iconcologia.net
Anna Lucas, MD, +34 93 260 77 20, alucas@iconcologia.net
About this study
Official title: 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
- Conditions
- Brain Neoplasms
- Being tested
- Intraoperative Radiotherapy (IORT), Brain surgery
- Keywords
- Brain metastases, neurosurgery, intraoperative radiotherapy, local therapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Radiotherapy (IORT)Radiation
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.
Brain surgeryProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Radiotherapy (IORT) | Experimental | Intraoperative Radiotherapy (IORT) administered during surgery Receives: Radiation: Intraoperative Radiotherapy (IORT); Procedure: Brain surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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)
Measured: 12 months
Median overall survival (OS)
Time (in months) from surgery of brain metastases to death by any cause
Measured: 12 months
Change in neurocognitive performance (compared to baseline): Minimental
Assessed by minimal mental scale examination
Measured: 6, and 12 months
Change in neurocognitive performance (compared to baseline): Trail making
Assessed by trail making test
Measured: 6, and 12 months
Change in neurocognitive performance (compared to baseline): Repetition
Assessed by number repetition test (forward and backward)
Measured: 6, and 12 months
Change in neurocognitive performance (compared to baseline): Oral
Assessed by controlled oral word association test
Measured: 6, and 12 months
Change in neurocognitive performance (compared to baseline): Semantic
Assessed by semantic word association
Measured: 6, and 12 months
Quality of life (QoL)
Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)
Measured: 6, and 12 months
Radiation-related (acute / early delayed / late) neurotoxicity
Assessed by regular neurological examinations combined by serial MRI scans
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start17 Jun 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intraoperative Radiation Therapy (IORT)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miquel Macià, MD, Principal investigator, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084092
- Sponsor's protocol ID
- IORT_BRAIN_MET_2019
- Acronym
- IORT_BRAINM1
- Status last verified
- Aug 2022
- First submitted
- 8 Apr 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IORT After Surgical Resection of Brain Metastases: Feasibility and Efficacy Phase II Trial
- ClinicalTrials.gov ID
- NCT05084092
- Acronym / sponsor ID
- IORT_BRAINM1 / IORT_BRAIN_MET_2019
- Conditions
- Brain Neoplasms
- Keywords
- Brain metastases, neurosurgery, intraoperative radiotherapy, local therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intraoperative Radiation Therapy (IORT)
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Radiotherapy (IORT) | Experimental | Radiation: Intraoperative Radiotherapy (IORT), Procedure: Brain surgeryIntraoperative Radiotherapy (IORT) administered during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Intraoperative Radiotherapy (IORT) |
| Brain surgerySurgery 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 | Procedure or surgery | Intraoperative Radiotherapy (IORT) |
Primary outcome
Median local progression free survival (PFS)
Time frame: 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.
11 secondary outcomes
Median regional PFS (rPFS)
Time frame: 12 months
Global PFS (gPFS)
Time frame: 12 months
Median time to the initiation of systemic therapies
Time frame: 12 months
Median overall survival (OS)
Time frame: 12 months
Change in neurocognitive performance (compared to baseline): Minimental
Time frame: 6, and 12 months
Change in neurocognitive performance (compared to baseline): Trail making
Time frame: 6, and 12 months
Change in neurocognitive performance (compared to baseline): Repetition
Time frame: 6, and 12 months
Change in neurocognitive performance (compared to baseline): Oral
Time frame: 6, and 12 months
Change in neurocognitive performance (compared to baseline): Semantic
Time frame: 6, and 12 months
Quality of life (QoL)
Time frame: 6, and 12 months
Radiation-related (acute / early delayed / late) neurotoxicity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miquel Macià, MD principal investigator
Institut Català d'Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intraoperative Radiotherapy (IORT) and Brain surgery in people with Brain Neoplasms, run by Institut Català d'Oncologia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miquel Macià, MD (+34 93 260 77 20, mmacia@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median local progression free survival (PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.