RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases
- 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
- 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.