This trial studies how well tumor-treating fields therapy works in preventing brain tumors in participants with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and/or reverse tumor growth by disrupting the way cancer cells grow.
PRIMARY OBJECTIVES: I. To measure the feasibility and compliance of NovoTTF-200A as prophylactic cranial tumor treatment fields (TTF) therapy, determined by percent (%) of patients continuing TTF therapy until intracranial tumor progression, discontinuation due to dose limiting toxicity (DLT), or 6 months. SECONDARY OBJECTIVES: I. To evaluate time to intracranial failure after NovoTTF-200A. II. To evaluate overall survival after NovoTTF-200A. III. To evaluate the rates of intracranial failure at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A. IV. To evaluate intracranial failure free survival after NovoTTF-200A. V. To evaluate the rate of decline in Hopkins Verbal Language Test-Revised (HVLT-R) free recall, delayed recall and delayed recognition, Controlled Oral Word Association Test (COWAT) and Trail Making Test (TMT) Parts A and B at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A. VI. To evaluate time to neurocognitive failure after NovoTTF-200A. VII. To evaluate neurocognitive failure-free survival after NovoTTF-200A. VIII. To evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC Quality of life Questionnaire C30) with BN20 addendum after NovoTTF-200A. IX. To assess adverse events, severity, and frequency associated with NovoTTF-200A using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. OUTLINE: Participants undergo tumor-treating fields therapy using the NovoTTF-200A device over 18 hours per day for a minimum of 4 weeks and up to 1 year in the absence of disease progression, unacceptable toxicity, or intracranial failure. After completion of study treatment, participants are followed up at 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Undergo TTF therapy
Undergo TTF therapy
Ancillary studies
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Percentage of Patients Continuing Therapy Until Intracranial Tumor
Count of patients developed intracranial tumor divided by total number of patients.
Time frame: Up to 6 months
Time to Intracranial Failure
Time to intracranial failure with death as a competing risk will be estimated using cumulative incidence function (CIF) and reported with a one-sided 95% confidence interval.
Time frame: Up to 3 years
Overall Survival
Estimated using the Kaplan-Meier method.
Time frame: Up to 3 years
Rate of Intracranial Failure
Estimated using the cumulative incidence function
Time frame: Up to 12 months
Rate of Decline in Cognitive Function
Measured by Hopkins Verbal Language Test
Time frame: Up to 12 months
Time to Neurocognitive Failure
Measured by Hopkins Verbal Language Test
Time frame: Up to 3 years
Neurocognitive Failure-free Survival
Measured by Hopkins Verbal Language Test
Time frame: Up to 3 years
Evaluate Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4)
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Masking
NONE
Enrollment
2
Time frame: Up to 3 years
Incidence of Adverse Events
Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 12 months