Details

Details

Title Dose Escalation for Larger Brain Metastases: Phase I/II Study

IRB CASE8312

CC 13-221

Hospital Main Campus, Main Campus

Phase Phase 1, Phase 2

Disease Brain

Description

Description

Primary Endpoint
  1. To determine the incidence of acute and long-term toxicities with increasing dose of SRS (Phase I)
  2. To determine if local control may be improved with increasing doses of SRS (Phase II) [RECIST Criteria will be used to assess response. Care will be taken to differentiate radiation necrosis from recurrence.]
Secondary
  1. To determine the risk of acute and long-term toxicity with increasing dose of SRS (Phase II)
  2. To determine if there is increased neurocognitive toxicity with increased dose of SRS
  3. To determine the rate of radiation necrosis / steroid dependency
  4. To determine if quality of life is affected more by tumor recurrence versus radiation necrosis. This includes assessment of progression free survival, overall survival, local failure, and number of patients who receive bevacizumab, laser interstitial thermal therapy, or surgery for presumed radiation necrosis.
Inclusion Criteria

Inclusion Criteria

  1. Any patient undergoing SRS for brain metastases.
  2. Lesions to be treated under this protocol must be > 2 cm, but ≤ 4.0 cm in diameter.
  3. Patients may have had prior therapy including:
    1. WBRT > 3 months ago
    2. SRS to other brain metastases
  4. Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront.
  5. Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies.
  6. Patients must be 18 years or older
  7. Patient must be able to provide written informed consent
Exclusion Criteria

Exclusion Criteria

  1. Patients receiving SRS to resection bed
  2. Planned concurrent WBRT
  3. Leptomeningeal metastases
  4. Small cell lung cancer, lymphoma, and germ cell histologies.
  5. Inability to participate in study activities due to physical or mental limitations.
  6. Inability or unwillingness to return for all the required follow-up visits.
  7. Conformality index 2.0 or less cannot be achieved, or homogeneity index is > 2.0.
  8. Unable to deliver 10 Gy or less to optic nerve/chiasm
  9. Brainstem location is excluded from this study