Details

IRB Study Number 13-143

Status Recruiting

Location Cleveland Clinic Main Campus

Institute Taussig Cancer Institute

Description

Description

Primary

  1. To determine the safety (risk of acute and long-term toxicities) of neoadjuvant radiosurgery at escalating doses followed by surgical resection of brain metastases. (Phase I)

  2. To determine the local control of brain metastases treated with neoadjuvant radiosurgery followed by surgical resection. (Phase II)
    Secondary

  3. To determine the rate of distant brain failure when brain metastases are managed with neoadjuvant radiosurgery followed by surgical resection

  4. To estimate the rate of salvage surgery, WBRT, or SRS for patients treated with neoadjuvant radiosurgery followed by surgical resection
  5. To estimate neurocognitive outcomes for patients treated with neoadjuvant radiosurgery followed by surgical resection
  6. To determine the rate of radiation necrosis / steroid dependency
  7. To estimate quality of life for patients treated with neoadjuvant radiosurgery followed by surgical resection
  8. To determine the radiobiologic impact of neoadjuvant radiosurgery for resected brain metastases.

Inclusion Criteria

Inclusion Criteria

  1. Patient must be at least 18 years of age and have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
  2. 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.
  3. Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection
  4. Patient must have a Karnofsky Performance Score of ≥ 70.

Exclusion Criteria

Exclusion Criteria

  1. Patient deemed medically unfit to undergo surgical resection of brain metastasis.
  2. Prior whole brain radiotherapy
  3. Patient with contraindication for imaging with MRI
  4. Inability to participate in study activities due to physical or mental limitations.
  5. Inability or unwillingness to return for all the required follow-up visits.
  6. At the time of planning, unable to deliver 10 Gy or less to optic nerve/chiasm
  7. Tumor located in the brainstem
  8. Imaging or cytologic evidence of leptomeningeal disease