Clinical trial · Interventional
Radiosurgery Before Surgery for the Treatment of Brain Metastases
Preoperative Radiosurgery for Brain Metastases Planned for Surgical Resection: A Two Arm Pilot Study
NCT04895592CI-TRIAL-00111483completedEarly Phase 1ClinicalTrials.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)
This early phase I trial identifies the side effects of stereotactic radiosurgery before surgery in treating patients with cancer that has spread to the brain (brain metastases). Radiation may stimulate an anti-tumor immune response. Giving stereotactic radiosurgery before surgery may reduce the risk of the cancer coming back after surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Neoplasm in the Brain | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Resection | Procedure | — | UNRESOLVED |
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (SRS, low dose dexamethasone, surgery)
- description
- Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive low dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
- interventionNames
- Drug: Dexamethasone
- Procedure: Resection
- Radiation: Stereotactic Radiosurgery
- type
- EXPERIMENTAL
- label
- Arm B (SRS, high dose dexamethasone, surgery)
- description
- Patients undergo SRS to the brain metastasis for 1-3 fractions over 1-5 days. Patients also receive high dose dexamethasone PO or IV for 2-21 days until the day of surgical resection. Patients then undergo surgical resection.
- interventionNames
- Procedure: Resection
- Radiation: Stereotactic Radiosurgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years * Prior or suspected diagnosis of malignancy * Brain metastases visible on contrasted magnetic resonance imaging (MRI) brain * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Life expectancy \> 12 weeks as determined by the investigator * Patients must have adequate organ function as determined by Neurosurgery to undergo surgery * Willingness and ability of the subject to comply with scheduled visits, study procedures, and study restrictions * Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation * Patient must have a negative pregnancy test, be actively taking oral contraceptives or have undergone a hysterectomy Exclusion Criteria: * Patients on any immunosuppressive medication other than dexamethasone * Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Human immunodeficiency virus (HIV)-positive * Pregnant or nursing women are excluded * Prior whole brain radiotherapy or SRS to the same site planned for surgery
References
Publications (1)
- DERIVEDJansen CS, Pagadala MS, Cardenas MA, Prabhu RS, Goyal S, Zhou C, Chappa P, Vo BT, Ye C, Hopkins B, Zhong J, Klie A, Daniels T, Admassu M, Green I, Pfister NT, Neill SG, Switchenko JM, Prokhnevska N, Hoang KB, Torres MA, Logan S, Olson JJ, Nduom EK, Del Balzo L, Patel K, Burri SH, Asher AL, Wilkinson S, Lake R, Kesarwala AH, Higgins KA, Patel P, Dhere V, Sowalsky AG, Carter H, Khan MK, Kissick H, Buchwald ZS. Pre-operative stereotactic radiosurgery and peri-operative dexamethasone for resectable brain metastases: a two-arm pilot study evaluating clinical outcomes and immunological correlates. Nat Commun. 2024 Oct 14;15(1):8854. doi: 10.1038/s41467-024-53034-6. PMID 39402027