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8110 Gatehouse Road, Falls Church, VA 22042

Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (Srs) Compared with Fractionated Srs (Fsrs) For Resected Metastatic Brain Disease (A071801)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04114981

Background Information

This study is being done to answer the following question: does fractionated (multiple treatment sessions) radiosurgery delivered to the surgical cavity in the brain (the part of the brain where the brain metastasis was resected) decrease the risk of tumor recurring in the surgical cavity compared to single fraction (single treatment session) radiosurgery?

The usual approach for patients who are not in a study is treatment with single fraction radiosurgery. These treatments can reduce symptoms and may stop the tumor from growing for a few months or longer.

Radiosurgery, despite its name, is a non-surgical procedure that delivers precisely-targeted radiation at much higher doses, in only a single (or few treatments) as compared to traditional radiation therapy. Radiosurgery utilizes immobilization (a head frame or a soft plastic mask that forms to the shape of your face that helps hold the head in place during treatment) during the procedure to allow very precise targeting of tumors. Radiosurgery is typically done as an outpatient procedure. For most patients, the actual time on the radiosurgery treatment machine is in the range of 20 to 90 minutes.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • Adults over the ages of 18
  • Three or fewer unresected brain metastases (dual based metastases are eligible)
  • For women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to pre-registration is required
    • Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment
  • The brain metastasis must be located >5mm of the optic chiasm and outside the brainstem
  • Additional eligibility in protocol

Ineligibility Information

  • Metastasis at a central nervous system primary site
  • Prior whole brain radiation therapy
  • Primary germ cell tumor, small cell carcinoma, or lymphoma
  • Evidence of leptomeningeal metastasis (LMD)
  • Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04114981