Neoadjuvant radiosurgery for brain tumors before surgery
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
PHASE1; PHASE2 · Case Comprehensive Cancer Center · NCT01891318
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 |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT01891318 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are medically unfit for surgical resection or have received prior whole brain radiotherapy may not benefit from this study.
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 performed: While this approach is innovative, similar studies have shown promise in managing brain metastases with radiosurgery, indicating potential for success.
Eligibility criteria
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 this trial is running
Cleveland, Ohio and 1 other locations
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (WITHDRAWN)
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (RECRUITING)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tumors Metastatic to Brain