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

Completed · Phase 2

Conditions studied: Brain Metastasis, Bladder Cancer, Breast Cancer, Cervical Cancer, Colon Cancer, HEENT Cancer, Lung Cancer, Melanoma, Pancreatic Cancer, Prostate Cancer, Rectal Cancer, Sarcoma, Testicular Cancer

In brief

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.

Key facts

Study ID

NCT00587964

Run by

Memorial Sloan Kettering Cancer Center

People needed

51

Starts

2004-06-01

Expected to finish

2009-01-01

Last updated by the study team

2016-02-22

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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