This phase II single-arm pilot study will evaluate the safety and preliminary efficacy of Optune-Tumor Treating Fields (TTFields) therapy as a prophylactic approach to reducing small cell lung cancer (SCLC) that has spread to the brain (brain metastases). Optune is a portable battery powered device that produces alternating electrical fields, termed tumor treatment fields ("TTFields") within the human body. These TTFields are applied to the patient by electrically insulated surface transducer arrays, which function to disrupt the rapid cell division of cancer cells.
PRIMARY OBJECTIVE: I. Observed rate of brain metastases following TTFields therapy at 6 months. SECONDARY OBJECTIVES: I. Observed rate of brain metastases following TTFields therapy at 12 months. II. Survival of participants with SCLC after using TTFields therapy. III. Usage and overall safety characteristics of TTFields therapy. IV. Quality of life among participants using TTFields therapy. V. Observed rate of SCLC brain metastases at 6 months from the beginning of the 4th cycle of chemotherapy to development of brain metastases. OUTLINE: Participants will receive TTFields therapy on a continuous basis (i.e., 18-24 hours a day, 7 days a week) for a period of 12 months or until the development of brain metastases, whichever comes first. Participants will be able to carry the device in an over-the-shoulder bag or backpack so that they can receive continuous at-home treatment. The investigator or other designated healthcare provider will provide detailed instructions regarding the placement/replacement and positioning of the transducer arrays on the participants head. TTFields are applied to the shaved scalp via two pairs of orthogonally positioned transducer arrays. Each pair of transducer arrays will be centered on the participants shaved head such that one pair is placed on the left and right side of the head, and the second pair placed anteriorly and posteriorly. Transducer arrays should be replaced every 2 to 3 days, with a slight relocation of the new arrays \~2 cm from the prior location. After completion of study treatment, patients are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
3
Ancillary studies
Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Incidence of Small Cell Lung Cancer (SCLC) Brain Metastases at 6 Months
Time frame: 6 months following start of tumor treating fields (TTFields) therapy
Incidence of SCLC Brain Metastases at 12 Months
Time frame: 12 months following start of TTFields therapy
Overall Survival
Overall survival of participants with SCLC after using TTFields therapy. The distribution of overall survival will be graphically described using Kaplan-Meier plot, for all subjects together, and for each disease group (extensive stage and limited stage).
Time frame: Death or last follow up following start of TTFields therapy, whichever comes first (assessed at 6, 12, 24, 36 and 60 months)
Incidence of TTfield Related Adverse Events
Time frame: Continuously following start of TTFields therapy (up to 12 months)
Incidence of Cognitive Adverse Events (AEs) Using Mini Mental State Exam (MMSE)
Incidence of cognitive AEs will be assessed by measuring changes in MMSE scores over time. Descriptive statistical analysis will be conducted.
Time frame: Continuously following start of TTFields therapy (up to 12 months)
Change in Quality of Life Over Time: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
Quality of life (QoL) among participants using TTFields therapy evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). For questions 29 and 30, a 7-points scale is used. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Summary of QoLs and its change over time will be presented graphically.
Time frame: 6 and 12 months following start of TTFields therapy
Incidence of SCLC Brain Metastases
Time frame: Up to 180 days from Day 1 of the 4th cycle of chemotherapy (each cycle is 28 days)
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