Using intraoperative radiotherapy for brain metastases treatment
Intraoperative Radiotherapy in Patients With Brain Metastases
NA · Parc de Salut Mar · NCT04847284
This study is testing if a special type of radiation given during brain surgery can help people with brain metastases do better and have fewer side effects compared to regular radiation treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Parc de Salut Mar (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04847284 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of intraoperative radiotherapy (IORT) in patients undergoing surgical excision of brain metastases. The approach involves administering a dose of 20 Gy of IORT during surgery, aiming to determine if it is at least as effective and safe as traditional radiation therapies. The study addresses the high local recurrence rates after surgical resection and seeks to provide a more effective treatment option that minimizes neurocognitive impairment. Participants will be monitored for outcomes related to tumor control and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed brain metastases that can be surgically removed.
Not a fit: Patients with multiple brain metastases or those with specific contraindications to surgery or anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and convenient option for patients with brain metastases, potentially reducing recurrence rates.
How similar studies have performed: While the efficacy of intraoperative radiotherapy is being explored, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy) * Adequate birth control Exclusion Criteria: * 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 * Contraindication against anesthesia, surgery, MRI and/or contrast agents * Pregnant or breast-feeding women
Where this trial is running
Barcelona
- Hospital del Mar — Barcelona, Spain (RECRUITING)
Study contacts
- Study coordinator: Palmira Foro, MD, PhD
- Email: pforo@psmar.cat
- Phone: 628118443
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metastases, Brain metastases, Intraoperative radiotherapy, Intrabeam