Clinical trial · Interventional
A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases
A Phase II Study of Pre-Operative Stereotactic Radiosurgery Followed by Surgical Resection for Brain Metastases
NCT05341739CI-TRIAL-00086789active not recruitingN/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 is a research study to determine if performing stereotactic radiosurgery (SRS) prior to surgical resection of the brain metastasis (tumor) will improve local control, in other words, increase the possibility of total removal of the primary tumor without local recurrence on longterm follow up. This research study will also determine if pre-operative SRS will lower the risk of radionecrosis that is the breakdown of body tissue at the original tumor site, and the development of leptomeningeal disease.
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, Adult | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-operative Stereotactic Radiosurgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pre-Operative Stereotactic Radiosurgery (SRS)
- description
- Subjects are treated using the standard of care SRS to a total dose of 24-27 Gray (Gy) in 3 fractions with a once daily fractionation or every other day at treating physician discretion. The preferred dose will be 27 Gy, with ability to drop dose down to 24 Gy if normal tissue constraints cannot be met. It should be noted, that while the dosing remains within standard of care, the timing of the radiation (pre-operative) is still not considered standard of care but is supported by emerging data as described in the study background. Additional metastatic lesions may be treated using SRS according to institutional practices. The radiation dose prescribed to the non-index lesions is at the discretion of the treating physicians. Surgical resection will be performed within 2 weeks of completion of SRS.
- interventionNames
- Other: Pre-operative Stereotactic Radiosurgery
Primary outcomes (1)
- measure
- Radiographic Local Control
- timeFrame
- 4-5 Years from first subject enrolled.
- description
- Radiographic local control at 1 year following completion of pre-operative SRS followed by surgical resection of brain metastasis. Local control will be according to the Response Assessment criteria for Neuro-Oncology (RANO) for brain metastases.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologic proof or unequivocal cytologic proof of solid tumor malignancy. This may be obtained from either the primary site or any metastatic site 2. Solid tumor brain metastases 3. Age≥ 18 years 4. Karnofsky Performance Status ≥70 5. Patient must have agreed to undergo surgical resection to manage at least 1 brain metastasis 6. Maximum tumor diameter of index lesions \<5 cm. (Index lesion defined as the brain metastasis which will undergo surgical resection) 7. Brain MRI within 1 month of initiation of brain SRS 8. No prior whole brain radiotherapy (WBRT) or radiation therapy directed to index brain metastases 9. Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child 10. Patient must have the ability to understand and the willingness to sign a written informed consent document 11. All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines 12. Patients receiving prior SRS for brain metastases in other locations of the brain are eligible 13. Patients with multiple brain metastases planned for surgical intervention are eligible for this study. Each individual brain metastasis will be treated Exclusion Criteria: 1. Prior WBRT or SRS to the index lesion 2. Brain metastasis greater than or equal to (≤) 5 cm in maximum diameter 3. Patients must not have a serious medical or psychiatric illness that would in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits. 4. Karnofsky Performance Status (KPS) less than (\<)70. 5. Patients with absolute contraindication to MRI imaging are not eligible for the study 6. Patients who are pregnant are excluded from the study.
References
Publications (0)
Data not yet available
No reference posted for this study.