Pre-Operative Vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors

Who is this study for? Adult patients with Solid Tumors
What treatments are being studied? Stereotactic Radiosurgery
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure, Radiation, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>= 18 years

• Histological or cytological confirmation of solid tumor malignancy and/or clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings

• Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate

• Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=\< 10 metastases)

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2

• Provide written informed consent or have a legally authorized representative who is responsible for the care and well-being of the potential study participant, provide consent

• Willing to continue follow-up visits, either at the enrolling institution or with a local medical doctor as clinically appropriate, and according to the study timeline. Clinical notes and digital copies of imaging must be provided to the enrolling site if follow-up is done externally

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Maryland
National Institutes of Neurological Disorders and Stroke, NIH
RECRUITING
Bethesda
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2018-11-19
Estimated Completion Date: 2025-11-08
Participants
Target number of participants: 140
Treatments
Active_comparator: Arm A (Post-operative SRS)
Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery. Patients also undergo a planning CT or MRI before radiation and tissue and CSF sample collection at time of surgery. Additionally, patients undergo MRI and option blood sample collection throughout the study.
Experimental: Arm B (Pre-operative SRS)
Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery. Patients also undergo a planning CT or MRI before radiation and tissue and CSF sample collection at time of surgery and MRI throughout the study. Additionally, patients undergo MRI and option blood sample collection throughout the study.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov