Clinical trial · Interventional
A Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases
A Phase II Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases
NCT03368625CI-TRIAL-00104566NASRScompletedN/AClinicalTrials.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 study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).
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 |
|---|---|---|---|
| Brain Metastases | 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
- Arm 1
- description
- Neoadjuvant SRS
- interventionNames
- Radiation: Stereotactic Radiosurgery
Primary outcomes (1)
- measure
- Radiation toxicity
- timeFrame
- 1 year
- description
- The rate at 1 year of symptomatic (≥grade 2) radiation toxicity
Secondary outcomes (5)
- measure
- local control
- timeFrame
- 1 year
- description
- 1-year local control (PR+CR) of the index lesion resulting from NaSRS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Lymphoma, small cell carcinoma, and seminoma are excluded * A lesion appropriate for resection, not previously treated with SRS. Lesions should be \> 2 cm and \< 4 cm in largest dimension, and require resection ( e.g. due to mass effect or to obtain a tissue diagnosis). Index lesions will be treated with SRS and surgery, as outlined in the treatment section of the protocol. * Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate NaSRS, e.g., the ability to lie flat in a stereotactic head frame. * Any unresected lesions or lesions for which there is no planned immediate resection (non index lesions) must measure \< 3.0 cm in maximal extent on the contrasted MRI or CT brain scan obtained ≤ 35 days prior to pre-registration. Unresected lesions will be treated with SRS as outlined in the treatment section of the protocol. . * ECOG ≤ 2 * MRI confirmed 1-6 lesions, one of which is the index lesion. Each non-index lesion (up to 5) must measure ≤ 3.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection. Note: The pre-registration MRI may be obtained ≤ 35 days prior to enrolment. Exclusion Criteria: * Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved. * pregnancy * Prior cranial radiotherapy targeting the index lesion, or any prior WBRT. * Inability to complete a MRI with contrast of the head, or a known allergy to gadolinium. * Cytotoxic Chemotherapy within 7 days prior to SRS (molecularly targeted therapies , including immune-modulatory drugs, can be given within seven days of SRS at the discretion of the treating physician) * Metastatic germ cell tumor, small cell carcinoma, or lymphoma or any primary brain tumor * Imaging Findings: * Widespread definitive leptomeningeal metastasis. * A brain metastasis that is located ≤ 2 mm of the optic chiasm * Evidence of midline shift * Fourth ventricular narrowing, concerning for hydrocephalus
References
Publications (1)
- DERIVEDHigazy R, Li D, Lau R, Millar BA, Laperriere N, Berlin A, Conrad T, Gutierrez-Valencia E, Zadeh G, Bernstein M, Kalyvas A, Spears J, Zips D, Vajkoczy P, Senger C, Acker G, Kongkham P, Shultz DB. Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases: An International, Multicenter, Single-Arm Phase II Trial. Neurosurgery. 2025 Apr 14;97(4):793-800. doi: 10.1227/neu.0000000000003451. PMID 40227031