This trial studies how well stereotactic radiotherapy followed by tumor treating fields therapy work in treating participants with small cell lung cancer that has spread to the brain. 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. Given stereotactic radiosurgery and tumor treating fields therapy may help to reduce the chances of cancers coming back in other parts of your brain that are not being treated with stereotactic radiosurgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03488472.
PRIMARY OBJECTIVES:
I. To determine the rate of distant brain metastases at 6 months in patients with small cell lung cancer (SCLC) brain metastases receiving stereotactic radiosurgery (SRS) followed by Novo Tumor Treating Fields (TTF)-200A.
SECONDARY OBJECTIVES:
I. Determine the feasibility of SRS in patients SCLC brain metastases followed by Novo TTF-200A.
II. Determine the rate of distant brain metastases and infratentorial recurrences at 1 year in patients with SCLC brain metastases receiving SRS followed by Novo TTF-200A.
III. Determine the rates of toxicity from SRS for patients with 10 or less brain metastases followed by Novo TTF-200A.
IV. Determine the rate of Common Terminology Criteria for Adverse Events (CTCAE) physician reported toxicity.
V. Determine the rate of neurocognitive toxicity using neurocognitive tests.
VI. Characterize quality of life using standardized metrics.
VII. Determine the rate of local control of targeted lesions.
VIII. Determine the rate of overall survival.
OUTLINE:
Participants undergo SRS on day 0 followed by TTF via NovoTTF-200A on days 1-7.
After completion of study treatment, participants are followed up at 1, 3, 6, 9, and 12 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorDrexell Hunter Boggs