Intraoperative Radiotherapy in Patients With Brain Metastases
ConditionBrain Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorParc de Salut Mar
About this trial
Intraoperative radiotherapy (IORT) is a new alternative for local radiotherapy with the advantages of dose escalation, reduced overall treatment time, and enhanced patient convenience, however the degree of efficacy is unknown, as well as and which is the most efficient dose.
The objective of this study is to evaluate the efficacy and safety of IORT in patients with surgical excision of brain metastases at a dose of 20 Gy is at least as effective and safe as other forms of radiation therapy in patients with resection of brain metastases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Karnofsky Performance Status ≥ 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 ( Central Nervous System i.e. non-CNS) tumor
Disqualifiers
Leptomeningeal spread and dural attachment (assessed pre- and intraoperatively)
Frozen section reveals primary CNS tumor, lymphoma, SCLC (Small-cell lung cancer) or germinoma
More than one brain metastasis
Psychiatric or social condition potentially interfering with compliance
Trial design
Design model
Single group
Treatments tested in this trial
Intraoperative radiotherapy
RadiationIntraoperative radiotherapy application immediately following resection of brain metastases.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Single armsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Median local progression free survival (lPFS)
Recurrence within a 0.5 cm margin around the resection cavity, assessed by serial magnetic resonance imaging (MRI scans) and response assessment criteria in neuro-oncology (RANO)
Time frame
6 months from the date of surgery.2
Radiation-related acute neurotoxicity
Neurotoxicity related to radiotherapy evaluated according to the scale of the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Score from 0 to 5, with 5 being the worst toxicity \- Acute toxicity: cerebral edema
Time frame
3 months from the date of surgery.3
Radiation-related late neurotoxicity
Neurotoxicity related to radiotherapy evaluated according to the scale of the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Score from 0 to 5, with 5 being the worst toxicity \- Late toxicity: radionecrosis.
Time frame
6 months from the date of surgery.Secondary outcomes
1
Median regional PFS (rPFS)
To any progression outside of the 0.5 cm margin around the resection cavity, assessed by serial MRI scans and RANO response assessment in neuro-oncology .
Time frame
6 months from the date of surgery2
Global PFS (gPFS)
The time (in months) from surgery to any intra- and extracranial tumor progress
Time frame
6 months from the date of surgery3
Median overall survival (OS)
The time (in months) from surgery of brain metastases to death from by any cause.
Time frame
6 months from the date of surgerySponsors and contacts
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Source ClinicalTrials.gov