Stereotactic Radiosurgery followed by Tumor Treating Fields Therapy in Treating Participants with Small Cell Lung Cancer with Brain Metastases

Status: Active

Description

This trial studies how well stereotactic radiotherapy followed by tumor treating fields therapy work in treating participants with small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Given stereotactic radiosurgery and tumor treating fields therapy may help to reduce the chances of cancers coming back in other parts of your brain that are not being treated with stereotactic radiosurgery.

Eligibility Criteria

Inclusion Criteria

  • All subjects must have history of histologically confirmed small cell lung cancer. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician
  • Newly diagnosed brain metastases (metastases on post-contract magnetic resonance imaging [MRI] obtained within six weeks of study entry) deemed to be amenable to SRS * Tumor size limited to largest volume < 10 cc * Longest diameter < 3 cm * Cumulative volume of all tumors =< 15 cc
  • At least one measurable lesion per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Criteria for brain metastasis
  • Prior prophylactic cranial irradiation (PCI) is allowed
  • Prior systemic therapy is allowed after diagnosis of brain metastases provided that restaging MRI shows measurable intracranial disease
  • Karnofsky performance status (KPS) of greater than or equal to 70
  • Life expectancy greater than 3 months
  • Must receive optimal therapy for extracranial disease and may continue on systemic therapy during TTF administration
  • Ability to operate the NovoTTF-200A device independently or with caregiver aid
  • Previous clinical trial enrollment is allowed
  • Subjects given written informed consent

Exclusion Criteria

  • History of prior brain metastases
  • Patients with significant edema leading to risk of brain herniation
  • History of prior whole brain radiotherapy (WBRT) other than prophylactic cranial radiation. Prophylactic cranial radiation with a maximum dose of 25 Gy delivered as 10 fractions is allowed. WBRT in excess of 25 Gy (anything over 25 Gy) is not allowed
  • Diffuse Leptomeningeal metastases with radiographic involvement in the brain and/or spinal cord. This does not include local leptomeningeal involvement which is defined as leptomeningeal enhancement within direct contact of targetable metastases
  • Implantable electronic device in the brain
  • 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)
  • Known allergies to medical adhesives or hydrogel
  • Currently pregnant or breastfeeding
  • Concurrent brain-directed therapy
  • Insufficient recovery from all active toxicities of prior therapies
  • Women of childbearing potential who are not using an effective method of contraception are excluded. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of SRS

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Drexell Hunter Boggs
Phone: 205-934-5581

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the rate of distant brain metastases at 6 months in patients with small cell lung cancer (SCLC) brain metastases receiving stereotactic radiosurgery (SRS) followed by Novo Tumor Treating Fields (TTF)-200A.

SECONDARY OBJECTIVES:

I. Determine the feasibility of SRS in patients SCLC brain metastases followed by Novo TTF-200A.

II. Determine the rate of distant brain metastases and infratentorial recurrences at 1 year in patients with SCLC brain metastases receiving SRS followed by Novo TTF-200A.

III. Determine the rates of toxicity from SRS for patients with 10 or less brain metastases followed by Novo TTF-200A.

IV. Determine the rate of Common Terminology Criteria for Adverse Events (CTCAE) physician reported toxicity.

V. Determine the rate of neurocognitive toxicity using neurocognitive tests.

VI. Characterize quality of life using standardized metrics.

VII. Determine the rate of local control of targeted lesions.

VIII. Determine the rate of overall survival.

OUTLINE:

Participants undergo SRS on day 0 followed by TTF via NovoTTF-200A on days 1-7.

After completion of study treatment, participants are followed up at 1, 3, 6, 9, and 12 months.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
University of Alabama at Birmingham Cancer Center

Principal Investigator
Drexell Hunter Boggs

Trial IDs

Primary ID UAB1793
Secondary IDs NCI-2018-01478
Clinicaltrials.gov ID NCT03488472