Neoadjuvant radiosurgery for brain tumors before surgery
Official title: Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
Run by Case Comprehensive Cancer Center · NCT01891318 · Data updated 2026-11-12
This study is testing if giving radiation treatment before surgery can help prevent brain tumors from coming back in people with brain metastases.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Status | Recruiting |
| Started | July 3, 2013 |
| Main results expected | January 2027 |
| Study ends | September 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT01891318 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with 1-4 brain metastases who have a Karnofsky performance score of 70 or higher and a prior histologic diagnosis of cancer, excluding certain types.
✕Probably not a fit
Patients who are medically unfit for surgical resection or have received prior whole brain radiotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase I/II trial investigates the effectiveness of neoadjuvant radiosurgery followed by surgical resection in preventing the recurrence of brain metastases. The study aims to assess the safety and optimal dosage of radiosurgery, as well as evaluate the local control of brain metastases post-treatment. Participants will undergo a dose-escalation approach to determine the best treatment strategy while monitoring for side effects and the need for additional therapies. The trial also seeks to understand the impact of this combined treatment on the rate of distant brain failure and other complications.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management and outcomes for patients with brain metastases.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in managing brain metastases with radiosurgery, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies * Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS * Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection * Patient must have a Karnofsky performance score of ≥ 70 Exclusion Criteria: * Patient deemed medically unfit to undergo surgical resection of brain metastasis * Prior whole brain radiotherapy * Patient with contraindication for imaging with MRI * Inability to participate in study activities due to physical or mental limitations * Inability or unwillingness to return for all the required follow-up visits * At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm * Tumor located in the brainstem * Imaging or cytologic evidence of leptomeningeal disease
Where it's running
-
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States Recruiting -
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States Withdrawn
Study contacts
- Principal investigator: Erin Murphy, MD — Case Comprehensive Cancer Center
- Study coordinator: Erin Murphy, MD
- Email: TaussigResearch@ccf.org
- Phone: 1-866-223-8100
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Robot-assisted bronchoscopy for peripheral lung lesions: comparing Monarch and ION platforms
Doctors are testing two FDA-cleared robotic bronchoscopy tools to see which more often successfully sample peripheral lung lesions during a bronchoscopy.
-
Safety and preliminary activity of BMS-986504 in unresectable MPNST
A new medicine called BMS-986504 is being tested to see if it is safe and may help people with unresectable malignant peripheral nerve sheath tumors, especially those whose tumors lack MTAP.
-
Wearable sensors and digital health in early cancer trials
This pilot study tests whether wearable activity tracking and electronic patient-reported outcomes can be feasibly used in early-phase cancer trials for adults.
-
HPV DNA-guided chemoradiation with Retifanlimab for locally advanced anal cancer
This study tests whether adjusting chemoradiation doses based on HPV ctDNA results and adding Retifanlimab after CRT can improve outcomes for adults with new, locally advanced anal cancer.
-
MiraBurst to help with changes in taste from cancer treatment
This study tests whether freeze-dried miracle fruit (MiraBurst) can improve taste changes in adults with solid tumors who are undergoing cancer treatment.
-
Memory-avoidance whole brain radiotherapy: trying to protect memory while treating brain metastases
This study tests whether memory-avoidance whole brain radiotherapy with memantine is better at preserving thinking and memory than hippocampal-avoidance whole brain radiotherapy with memantine for adults with brain metastases.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.