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TerminatedNot applicableNCT03607682
Official study title

Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer

Study summary

This trial studies how well tumor-treating fields therapy works in preventing brain tumors in participants with small cell lung cancer that has spread to other places in the body. Tumor-treating fields therapy involves the use of the NovoTTF-200A which delivers alternating electrical fields, or tumor treating fields, through ceramic discs placed on the head. This electric force may slow and/or reverse tumor growth by disrupting the way cancer cells grow.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTumor Treating Fields (TTF) Therapy and NovoTTF-200A Device

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 4, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Vanderbilt-Ingram Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Vanderbilt-Ingram Cancer Center
Interventions being studied
Procedure: Tumor Treating Fields (TTF) Therapy; Device: NovoTTF-200A Device; Other: Quality-of-Life Assessment
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
03
Public criteria

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.

Requirements people may need to meetInclusion criteria
  • Life expectancy of \> 3 months
  • Histologically proven extensive stage small cell lung carcinoma (ES-SCLC) (any T any N and any M stage) within 6 months prior to start of study treatment with the NovoTTF-200A, with a partial or complete response to at least four cycles of first-line chemotherapy
  • Karnofsky performance status (KPS) \> 70
  • Neutrophil count \> 1.5 x 10\^9/L
  • Platelet count \> 100 x 10\^9/L
  • Bilirubin \< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \< 2.5 x ULN or \< 5 x ULN if patient has documented liver metastases
  • Serum creatinine \< 1.5 x ULN
Reasons someone may not be able to joinExclusion criteria
  • Evidence of brain metastases on magnetic resonance imaging (MRI) of brain with and without contrast
  • History of other prior malignancy within the past 5 years except for superficial skin cancers
  • No severe comorbidities:
  • History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea)
  • History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
  • History of cerebrovascular accident (CVA) within 6 months prior to start of study treatment
  • Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy
  • History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
  • Active implantable electronic medical devices in the brain; a skull defect, a shunt, or bullet fragments
  • Known allergies to medical adhesives or hydrogel
  • Unable to operate the NovoTTF-200A device independently or with the help of a caregiver
  • If a female, currently pregnant, breastfeeding, or unwilling to avoid pregnancy while on study treatment
  • Concurrent brain directed therapy (beyond NovoTTF-200A as per protocol)
  • Prior clinical trial participation with brain directed therapy
  • Concurrent treatment clinical trials

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Vanderbilt-Ingram Cancer CenterNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 4, 2020. Always confirm current availability with the study team.

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