Recruiting
Phase 1
Phase 2

Radiosurgery

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT01891318

Conditions

Tumors Metastatic to Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

radiosurgery

therapeutic conventional surgery

quality-of-life assessment

Study Details

Brief summary:

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.

Conditions

Tumors Metastatic to Brain

Study ID

NCT01891318

Start date

Jul 3, 2013

Status verified date

Aug, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (radiosurgery, surgery)

Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.

Interventions

radiosurgery

Undergo radiosurgery

therapeutic conventional surgery

Undergo surgical resection

quality-of-life assessment

Ancillary studies

Primary outcome measure

  • Maximum tolerated dose (MTD) [ Time Frame: Day 0 ]
  • Proportion of participants without local failure (Phase II) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Erin Murphy, MD

1-866-223-8100TaussigResearch@ccf.org

Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Erin Murphy, MD

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Erin Murphy, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.