Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT01891318
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Tumors Metastatic to Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • radiosurgery — RADIATION
    Undergo radiosurgery
  • therapeutic conventional surgery — PROCEDURE
    Undergo surgical resection
  • quality-of-life assessment — PROCEDURE
    Ancillary studies

Study Details

This Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.

Key Dates

Start date
Jul 3, 2013
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (radiosurgery, surgery)
    Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Day 0 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cleveland Clinic, Case Comprehensive Cancer CenterClevelandOhio44195
Erin Murphy, MD
[email protected]
866-223-8100
Erin Murphy, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-

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By research site
Cleveland Clinic, Case Comprehensive Cancer Center· Cleveland, OHUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH