NCT03750227

Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors

Recruiting now Phase 3 Last updated 24 December 2025

What this trial tests

Phase 3 trial testing Conventional Surgery in Malignant Solid Neoplasm in 140 participants. Currently enrolling.

Timeline

19 November 2018

Primary endpoint
8 November 2030

8 November 2030

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	140
Start date	19 November 2018
Primary completion	8 November 2030
Estimated completion	8 November 2030
Sites	4 locations across United States

Drugs / interventions tested

• Conventional Surgery
• Questionnaire Administration
• Stereotactic Radiosurgery
• Computed Tomography
• Magnetic Resonance Imaging
• Biospecimen Collection — full drug profile →

Conditions studied

• Malignant Solid Neoplasm — all drugs for Malignant Solid Neoplasm →
• Metastatic Malignant Neoplasm in the Brain — all drugs for Metastatic Malignant Neoplasm in the Brain →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Malignant Solid Neoplasm or Metastatic Malignant Neoplasm in the Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase III trial studies the side effects and how well stereotactic radiosurgery (SRS) works before or after surgery in patients with tumors that has spread to the brain or that can be removed by surgery. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Brain metastases: A Society for Neuro-Oncology (SNO) consensus review on current management and future directions.
   Aizer AA, Lamba N, Ahluwalia MS, Aldape K, et al · · 2022 · cited 116× · PMID 35762249 · DOI 10.1093/neuonc/noac118
2. Brain metastases: An update on the multi-disciplinary approach of clinical management.
   Mitchell DK, Kwon HJ, Kubica PA, Huff WX, et al · · 2022 · cited 39× · PMID 33864773 · DOI 10.1016/j.neuchi.2021.04.001
3. Update on the Management of Brain Metastasis.
   Singh K, Saxena S, Khosla AA, McDermott MW, et al · · 2022 · cited 38× · PMID 36422836 · DOI 10.1007/s13311-022-01312-w
4. Modern Radiation Therapy for the Management of Brain Metastases From Non-Small Cell Lung Cancer: Current Approaches and Future Directions.
   Mantovani C, Gastino A, Cerrato M, Badellino S, et al · · 2021 · cited 37× · PMID 34796118 · DOI 10.3389/fonc.2021.772789
5. Surgically targeted radiation therapy (STaRT) trials for brain neoplasms: A comprehensive review.
   Odia Y, Gutierrez AN, Kotecha R. · · 2022 · cited 18× · PMID 36322100 · DOI 10.1093/neuonc/noac130
6. Evaluation of the impact of pre-operative stereotactic radiotherapy on the acute changes in histopathologic and immune marker profiles of brain metastases.
   Kotecha R, Tonse R, Menendez MAR, Williams A, et al · · 2022 · cited 18× · PMID 35296750 · DOI 10.1038/s41598-022-08507-3
7. Modern Stereotactic Radiotherapy for Brain Metastases from Lung Cancer: Current Trends and Future Perspectives Based on Integrated Translational Approaches.
   Levis M, Gastino A, De Giorgi G, Mantovani C, et al · · 2023 · cited 11× · PMID 37760591 · DOI 10.3390/cancers15184622
8. Outcome comparison of patients who develop leptomeningeal disease or distant brain recurrence after brain metastases resection cavity radiosurgery.
   Teyateeti A, Brown PD, Mahajan A, Laack NN, et al · · 2021 · cited 9× · PMID 33860228 · DOI 10.1093/noajnl/vdab036