NCT03995667

Tumor Treating Fields (TTFields) Therapy to Manage Brain Metastases in Small Cell Lung Cancer

Prophylactic Tumor Treating Fields in Management of Patients With Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Extensive Stage Lung Small Cell Carcinoma
• Limited Stage Lung Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage IA1 Lung Cancer AJCC v8
• Stage IA2 Lung Cancer AJCC v8
• Stage IA3 Lung Cancer AJCC v8
• Stage IB Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Questionnaire Administration	Ancillary studies
DEVICE	Tumor Treating Fields Therapy	Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.

Timeline

• Start date: 2019-06-11
• Primary completion: 2022-08-04
• Completion: 2022-08-04
• First posted: 2019-06-24
• Last updated: 2023-10-30
• Results posted: 2023-10-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study