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.
Status | Completed |
Enrollment | 51 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed malignancy with the presence of one or two intraparenchymal brain metastases (newly diagnosed patients may be registered based on radiologic confirmation if pathology is unavailable) - Age = 18 years - Karnofsky performance status = 70 - Neurologic Function Status 0-2 - Patients may have extracranial sites of metastatic disease - Adequate bone marrow reserve (hemoglobin = 8 grams, absolute neutrophil count = 1000/mm3, platelets = 50,000/mm3) - Patient must sign a study specific informed consent form. Exclusion Criteria: - Major medical illness including poor cardiac, pulmonary or renal status which would result in patient being a high risk candidate for neurosurgical procedure - Inability to obtain histologic proof of malignancy - Patients with leptomeningeal metastases documented by MRI or CSF evaluation Patients with metastases within 10 mm of the optic apparatus so that some portion of the optic nerve or chiasm would be included in the high dose SRS boost field - Patients with metastases in the brainstem, midbrain, pons, or medulla - Patients with small cell lung cancer, germ-cell tumors, lymphoma, leukemia and multiple myeloma are not eligible - Younger than 18 years of age - Karnofsky performance status of = 60 - Prior history of whole brain radiation therapy - Concomitant use of chemotherapy or targeted biological therapy (within a week of the SRS treatment) - = 3 metastases in the brain - Allergy to both CT and MR contrast dyes - Platelet count of < 100,000 or coagulation disorders that cannot be corrected or would render the surgery a high-risk procedure |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local Control | following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI. No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease. |
1 year | Yes |
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