A Study to Evaluate Optune vs. Prophylactic Cranial Irradiation (PCI) in Non-Small Cell Lung Cancer Patients

Overview

About this study

The purpose of this study is to evaluate the safety and preliminary effectiveness of Optune®-Tumor Treating Fields (TTFields) therapy vs. Prophylactic Cranial Irradiation (PCI) in Small Cell Lung Cancer (SCLC), a common disease with a high propensity for brain metastases.  Prophylactic cranial irradiation (PCI) is a standard therapy for reducing the risk of SCLC brain metastases. While PCI is associated with added survival benefit to patients with SCLC, the approach is associated with both acute and long-term toxicity.  As an alternative treatment option, directed electrical fields to the brain using the Optune® device is associated with decreasing the risk of tumor progression and improvement in overall survival in patients with glioblastoma multiforme (GBM).  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • ≥ 22 years of age.
  • Biopsy-proven SCLC.
  • Clinical Response to standard of care chemo- and/or radiotherapy, as defined by no thoracoabdominal tumor progression on CT imaging within 12 weeks prior to enrollment.
  • No contraindications to treatment with Optune®.
  • No other active malignancies, with exception of non-metastatic prostate cancer, treated Stage I breast cancer, skin malignancies. 
  • No brain metastases [gadolinium MRI < 12 weeks before enrollment].
  • No mental conditions that would prevent compliance.
  • Life expectancy of at least 3 months.
  • ECOG ≤ 2.

Exclusion Criteria:

  • Progressive disease.
  • Pregnant.
  • Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
  • Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Terence Sio, M.D., M.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

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