Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases

Phase 2

Completed

Conditions: Brain Metastasis
Bladder Cancer
Breast Cancer
Colon Cancer
Melanoma
Cervical Cancer
HEENT Cancer
Prostate Cancer
Sarcoma
Lung Cancer

Brief Summary: 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.

Detailed Description: 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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Treatment	Stereotactic Radiosurgery	-

Primary Outcome Measures

Name	Time	Method
Local Control	1 year	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Memorial Sloan-Kettering Cancer Center
🇺🇸
New York, New York, United States