Phase I Study of Fractionated Stereotactic Radiation Therapy

This is an interventional other trial for Brain Metastases Read More

Inclusion Criteria:

• Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration.
• Patients with measurable brain metastases who have a gadolinium contrast enhanced MRI obtained within 30 days prior to registration. Patients with CT based diagnostic imaging without MRI will not be allowed to enroll on this trial.
• No surgical resection of the target lesion, defined as ≥3 cm but ≤6 cm in size on MRI of the Brain with contrast
• Prior Whole Brain Radiation Therapy (WBRT) is allowed
• Age ≥ 18 years
• Karnofsky performance status ≥ 60 or ECOG ≤2
• Women of childbearing potential and male participants must practice adequate contraception
• History/Physical examination within 30 days prior to registration
• Life expectancy>3 months
• Patients are allowed to enroll if previously treated to other lesions with SRS
• Patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with FSRT. Other lesions may be treated concurrently with SRS or FSRT at the discretion of the treating physician but will not contribute to the study endpoints.

Exclusion Criteria:

• Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid examination (CSF)
• Plan for chemotherapy or targeted agents during treatment. All hormonal therapy and bone supportive therapy may be continued while patient is on study.
• Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed.
• Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy
• Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity.
• Previous treatment of the target lesions with radiotherapy.