Clinical trial · Interventional
Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
Phase II Study Determining the Efficacy of Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
NCT02514915CI-TRIAL-00091424completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm Brain | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Stereotactic Radiosurgery
- description
- Subjects will receive stereotactic radiosurgery prior to resection
- interventionNames
- Radiation: Stereotactic Radiosurgery
Primary outcomes (3)
- measure
- Local Control Rate (LCR) at 6 Months
- timeFrame
- At 6 months
- description
- The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 6 months compared to the tumor volume at the start of radiotherapy.
- measure
- Local Control Rate (LCR) at 12 Months
- timeFrame
- At 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Life expectancy of at least 12 weeks * Karnofsky performance status of at least 50 * No contraindications to MRI scanning with intravenous contrast. * MRI scan consistent with brain metastasis as per radiology report. * Target lesion must measure at least 15 mm in at least one dimension, and no more than 4 cm in any dimension. * Patients must have an extra-cranial primary tumor diagnosis. * Patients will have no more than 4 distinct lesions within the brain. At least 1 lesion has been recommended for surgical removal based on size, symptomology, or regional mass effect on the brain. * Additional lesions will each be treated with stereotactic radiosurgery. * Patients with a documented symptomatic lesion size smaller than 3cm requiring clinical surgical resection * Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts Exclusion Criteria: * Primary tumor histology of lymphoma, leukemia, multiple myeloma or germ cell tumor. Moribund status or status epilepticus. * Supratentorial mass effect with greater than 5 mm of midline shift or hydrocephalus. Infratentorial mass effect with fourth ventricle effacement or hydrocephalus. * More than four additional diagnosed brain metastases. * Contraindication to general anesthesia. * Adjacent tumor location to optic apparatus or brainstem, precluding achievement of meaningful dose with SRS. * Primary brain tumor. * Contraindication to MRI scans or intravenous contrast. * Pregnant and breast-feeding females.
References
Publications (0)
Data not yet available
No reference posted for this study.