Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

Stopped early · Phase 2

Conditions studied: Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

In brief

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.

Key facts

Study ID

NCT00814463

Run by

Duke University

People needed

1

Starts

2008-08-01

Expected to finish

2009-06-01

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years of age.
• Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS.
• Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2.
• Life expectancy of at least 3 months.

You may not qualify if…

• Radiographic or cytologic evidence of leptomeningeal disease.
• Patient with incomplete or partial resection.
• Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
• Patients with a resection cavity > 4 cm in maximal extent in any plane on contrasted MRI scan.
• Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus.
• Pregnant or need to breast feed during the study period.
• Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness.
• Brain surgery other than for resection of metastasis.
• Previous brain radiotherapy.
• Contraindication to SRS, WBRT, or MRI.

Where it is running

• Duke Comprehensive Cancer Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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