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Effect of TTFields in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)


Title METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC).
Therapeutic Area Brain Tumors, Brain Cancer, Non Small Cell Lung Cancer
Principal Investigator Suriya Jeyapalan, MD
Min Age 18 Years
Gender All
Contact Jessika E Silva
617 636-8897
More Information https://clinicaltrials.gov/ct2/show/NCT02831959

Overview

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Study Details

Inclusion Criteria

  • Brain metastases from primary Non-small-cell lung cancer (NSCLC)
  • Candidate for stereotactic radiosurgery (SRS)
  • Able independently or with the assistance of a caregiver to operate NovoTTF-100M device

Exclusion Criteria

  • No nursing or pregnant women
  • No complicating diseases and disorders including but not limited to uncontrolled seizures, cardiovascular disease, or active infection.
  • No prior treatment for brain metastases such as surgery, stereotactic radiosurgery, or radiation.

Study Requirements

If you are interested in participating in the study, you will need to come to clinic and have the following screening tests to make sure you are eligible to participate: physical and neurological exam, blood tests, MRI of the brain with contrast, and questions to test your thinking, memory, and quality of life. All subjects will receive stereotactic radiosurgery (SRS) to treat their brain metastases. Half of subjects will be randomized to receive standard supportive care after SRS. The other half of subjects will be randomized to receive NovoTTF-100M, the study device. The study device is made of sticky pads worn on the head at least 18 hours a day that are connected to a 3 lb. device. Wearing the device requires shaving your head and changing the sticky pads every 3-4 days. All subjects will come to clinic for a physical and neurological exam every 2 months until their tumor comes back. Subjects that were randomized to only receive standard supportive care will be given the option to crossover and receive the study device after the second time their tumor comes back.