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Table 4 Inclusion and Exclusion Criteria

From: Efficacy of pre-operative stereotactic radiosurgery followed by surgical resection and correlative radiobiological analysis for patients with 1–4 brain metastases: study protocol for a phase II trial

Inclusion Criteria

 1. Radiographically confirmed solid tumor brain metastases

 2. Criteria for surgical resection of at least one metastasis per neurosurgeon discretion

 3. A diagnostic MRI Brain or CT Head demonstrating the presence of 1–4 solid tumor brain metastases and lesion to be resected no more than 5 cm in any direction, performed within 30 days prior to stereotactic radiosurgery. If multiple lesions are present, then the total brain metastases volume can be no more than 30 cm3 excluding the lesion to be resected.

 4. For known primary, ds-GPA estimated median survival no less than 6 months

 5. For unknown primary, GPA estimated median survival no less than 6 months

 6. Surgical candidate per neurosurgeon discretion

 7. Surgical resection able to be performed within 1–4 days after radiosurgery

 8. Stereotactic radiosurgery candidate per radiation oncologist

 9. ≥ 18 years old at the time of informed consent

 10. Ability to provide written informed consent and HIPAA authorization

 11. Platelet count > 100 k/ml, Hgb > 7.5 g/dL, INR < 1.3, ANC > 1.5 k/ml

 12. Patients currently on cytotoxic chemotherapy or immunotherapy are eligible, not including anti-VEGF therapy

Exclusion Criteria

 1. Patients who received anti-VEGF therapy within 6 weeks prior to enrollment

 2. Major medical illnesses or psychiatric impairments, which in the investigator’s opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up

 3. Patients with more than 4 brain metastases on MRI Brain or CT Head

 4. Lesion to be resected is more than 5 cm

 5. Total volume of metastatic disease more than 30 cm3 excluding lesion to be resected

 6. Patients with leptomeningeal metastases documented by MRI or CSF evaluation

 7. Previous whole brain radiation therapy

 8. Previous radiation therapy to lesion to be resected

 9. Planned adjuvant focal therapy including additional radiation therapy to the brain

 10. Not a surgical candidate per neurosurgeon’s discretion

 11. Not a radiosurgical candidate per radiation oncologist’s discretion

 12. Surgery unable to be performed between 1 and 3 days after radiosurgery

 13. Women who are pregnant or nursing are not eligible as treatment involves unforeseeable risks to the fetus or child

 14. Patients who have a known primary and have an estimated median survival less than 6 months per ds-GPA

 15. Patients who have an unknown primary and have an estimated median survival less than 6 months per GPA