Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain
This study is a prospective single arm trial designed to study the safety and effectiveness of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with brain metastases from small cell lung cancer (SCLC).
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 6, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Drexell Hunter Boggs
- Interventions being studied
- Device: NovoTTF-200A; Radiation: Stereotactic Radiosurgery (SRS)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- Brain metastases that have not received radiotherapy previously (metastases on post-contrast MRI obtained within six weeks of study entry) deemed to be amenable to SRS.
- Longest diameter \< 4 cm
- Prior prophylactic cranial irradiation (PCI) is allowed. The maximum allowed dose is 25Gy in 10 fractions.
- 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.
- Age greater than or equal to 18 years.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at Birmingham (UAB), Hazelrig-Salter Radiation Oncology Center (HSROC)Birmingham, Alabama
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 6, 2023. Always confirm current availability with the study team.