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A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer
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.
Age
22 - No limit years
Sex
ALL
Healthy Volunteers
No
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Start Date
September 5, 2018
Primary Completion Date
June 2, 2020
Completion Date
July 13, 2020
Last Updated
August 4, 2020
2
ACTUAL participants
Tumor Treating Fields (TTF) Therapy
PROCEDURE
NovoTTF-200A Device
DEVICE
Quality-of-Life Assessment
OTHER
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
NCT03672773
NCT01737502
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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