Clinical Trial Details
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NCT01395407 : Phase I Trial of Stereotactic Radiosurgery Following Surgical Resection of Brain Metastases
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Pathologic proven diagnosis of solid tumor malignancy

- Age ? 18

- RPA class I or class II

- Mini Mental Status Exam (MMSE) ? 18 prior to study entry

- Karnofsky Performance Status ? 70%

- Single brain metastasis status post surgical resection with ? 1 cc of residual
enhancing tumor

- Up to 2 additional intact brain metastases to be treated with stereotactic
radiosurgery (SRS) alone

- Resection cavity volume on planning scan of ? 35 cc

- First presentation of brain metastases

- Post-operative MRI within 72 hours of surgical resection

Exclusion Criteria:

- Previous brain radiotherapy (SRS or WBRT)

- RPA class III

- Resection cavity volume > 35 cc

- Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors,
leukemias, or lymphomas) or unknown tumor histologies

- Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation
to 14 days after completion of radiation)

- Evidence of leptomeningeal disease by MRI and/or CSF cytology

- Current pregnancy

- More than 8 weeks between resection and radiosurgical procedure

- No metastases to brain stem, midbrain, pons, or medulla or within 7 mm of the optic
apparatus (optic nerves and chiasm)

- Inability to undergo MRI evaluation for treatment planning and follow-up
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