This phase II trial studies how well stereotactic radiosurgery works in treating patients with small cell cancer and 1-10 tumors that have spread to the brain from other parts of the body (brain metastases). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03391362.
PRIMARY OBJECTIVE:
I. To test the hypothesis that, among patients with small cell lung cancer (SCLC) or small cell cancer of any primary and 1-10 brain metastases, use of stereotactic radiation will not result in a worse rate of neurologic death than historical controls managed with whole-brain radiation therapy (WBRT).
SECONDARY OBJECTIVES:
I. All-cause mortality.
II. Quality of life.
III. Neurocognitive function.
IV. Ability to complete activities of daily living.
V. Performance status.
VI. Incidence and time to detection of new brain metastases.
VII. Incidence and time to local recurrence of existing brain metastases.
VIII. Incidence and time to development of radiation necrosis.
IX. Incidence and time to development of leptomeningeal disease.
X. Incidence and time to progressive intracranial disease.
XI. Incidence and time to salvage craniotomy.
XII. Incidence and time to additional central nervous system (CNS)-directed radiotherapeutic treatments (stereotactic or WBRT) after the initial course.
XIII. Incidence and time to the development of seizures.
OUTLINE:
Patients with lesions < 3 cm in maximum diameter undergo 1 fraction of stereotactic radiosurgery over 30-60 minutes, and patients with lesions > 3 cm in maximum diameter undergo stereotactic radiosurgery over 30-60 minutes once daily on days 1-5 for 5 fractions.
After completion of study treatment, patients are followed up every 2-3 months.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAyal Aaron Aizer
