Breast Cancer Clinical Trial
Official title:
Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases
For patients who have one or two metastases in the brain, the tumor(s) can often be removed
with surgery to relieve symptoms from the tumor(s) and to improve survival. However, about
half of all patients who have the tumor(s) removed with surgery will develop regrowth
(recurrence) of the tumor. To prevent this regrowth of tumor, some patients receive
radiation to the entire brain (whole brain radiation) after surgery. This involves daily
treatment for about two to three weeks, and may cause long-term neurological problems, such
as memory loss.
Stereotactic radiosurgery (SRS) is sometimes used instead of surgery to treat brain
metastasis. This involves the use of a special head frame and sophisticated computer
programs that enable us to deliver a high dose of radiation to a small focused area of the
brain in only one treatment.
Research has shown that the results of treatment with SRS are as good as surgical removal of
the tumor. SRS and surgical resection are considered the standard options for the treatment
of brain metastases. This Phase II clinical trial is studying the combination of these two
techniques. The purpose of this study is to evaluate the use of SRS following surgical
removal of brain metastases. The outcomes we will be looking at are tumor regrowth after
treatment and side effects of treatment.
This is a phase II trial in patients with 1-2 brain metastases treated with surgical resection followed by stereotactic radiosurgery boost. Following surgical resection, patients would receive a stereotactic radiosurgery boost to the surgical bed, 2-8 weeks after surgery. A dose of 15 to 22 Gy would be delivered in a single fraction. Patient would be subsequently followed clinically and radiologically to watch for local control as well as toxicity. If a recurrence or new metastasis(es) is detected, further treatment may be given, consisting of chemotherapy, surgery, whole brain radiation therapy or stereotactic radiotherapy. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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