Clinical Trial Details
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NCT01252797 : Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)
AgesMin: 19 Years Max: N/A
Inclusion Criteria:

- All subjects must have history of histologically confirmed malignancy. Brain biopsy
is not required unless diagnosis is judged to be in doubt by the treating physician.

- Newly diagnosed brain metastases (four or fewer by post-contrast MRI obtained within
six weeks of study entry)

- At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter
and deemed appropriate for surgical resection by the treating neurosurgeon.

- Karnofsky performance status (KPS) of greater than or equal to 60 (Appendix B)

- Age greater than 19

- Life expectancy greater than 12 weeks

- Subjects given written informed consent

Exclusion Criteria:

- Patients with small cell lung cancer and lymphoma are ineligible.

- More than four metastases by baseline post-contrast MRI

- Prior whole brain radiation therapy

- Insufficient recovery from all active toxicities of prior therapies

- Subjects who are deemed to be poor surgical risks by the treating neurosurgeon
because of medical comorbidities

- Pregnant or nursing women

- Women of childbearing potential who are not using an effective method of
contraception are excluded. Women of childbearing potential must have a negative
urine or serum pregnancy test within 24 hours prior to administration of SRS.
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