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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • radiosurgery
  • therapeutic conventional surgery
  • quality-of-life assessment

Treatment groups

36 Participants
are divided into 1 treatment group