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

NCT03995667 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-10-30

Study results available
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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.

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

OTHER

Questionnaire Administration

Ancillary studies

DEVICE

Tumor Treating Fields Therapy

Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.

Sponsors & Collaborators

  • NovoCure Ltd.

    collaborator INDUSTRY

  • Oregon Health and Science University

    collaborator OTHER

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Timur Mitin, MD · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2022-08-04
Completion
2022-08-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03995667 on ClinicalTrials.gov