Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03398694 : Pre-operative Stereotactic Radiosurgery Followed by Resection for Patients With Brain Metastases
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
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 - 3 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/cumm, Hgb > 7.5 gm/dL, INR < 1.3, ANC > 1.5 k/cumm

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, as there
is increased risk of fatal brain hemorrhage with surgical resection

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 - 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03398694      |      Link to official Clinicaltrials.gov listing
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