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
Qualifiers
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
Treatments tested in this trial
- Intraoperative radiotherapy
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov