NCT03607682

Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer

A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Extensive Stage Small Cell Lung Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Tumor Treating Fields (TTF) Therapy	Undergo TTF therapy
DEVICE	NovoTTF-200A Device	Undergo TTF therapy
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2018-09-05
• Primary completion: 2020-06-02
• Completion: 2020-07-13
• First posted: 2018-07-31
• Last updated: 2020-08-04
• Results posted: 2020-08-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study