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

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ClinicalTrials.gov Identifier: NCT03607682
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Albert Attia, Vanderbilt-Ingram Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Extensive Stage Small Cell Lung Carcinoma Procedure: Tumor Treating Fields (TTF) Therapy Device: NovoTTF-200A Device Other: Quality-of-Life Assessment Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To measure the feasibility and compliance of NovoTTF-200A as prophylactic cranial tumor treatment fields (TTF) therapy, determined by percent (%) of patients continuing TTF therapy until intracranial tumor progression, discontinuation due to dose limiting toxicity (DLT), or 6 months.

SECONDARY OBJECTIVES:

I. To evaluate time to intracranial failure after NovoTTF-200A. II. To evaluate overall survival after NovoTTF-200A. III. To evaluate the rates of intracranial failure at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.

IV. To evaluate intracranial failure free survival after NovoTTF-200A. V. To evaluate the rate of decline in Hopkins Verbal Language Test-Revised (HVLT-R) free recall, delayed recall and delayed recognition, Controlled Oral Word Association Test (COWAT) and Trail Making Test (TMT) Parts A and B at 2, 4, 6, 8, 10, 12 months after NovoTTF-200A.

VI. To evaluate time to neurocognitive failure after NovoTTF-200A. VII. To evaluate neurocognitive failure-free survival after NovoTTF-200A. VIII. To evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC Quality of life Questionnaire C30) with BN20 addendum after NovoTTF-200A.

IX. To assess adverse events, severity, and frequency associated with NovoTTF-200A using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

OUTLINE:

Participants undergo tumor-treating fields therapy using the NovoTTF-200A device over 18 hours per day for a minimum of 4 weeks and up to 1 year in the absence of disease progression, unacceptable toxicity, or intracranial failure.

After completion of study treatment, participants are followed up at 8 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Institutional Pilot Study of Prophylactic Cranial Tumor-Treating Fields for Patients With Extensive-stage Small Cell Lung Cancer
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Prevention (TTF therapy, NovoTTF-200A device) Procedure: Tumor Treating Fields (TTF) Therapy
Undergo TTF therapy

Device: NovoTTF-200A Device
Undergo TTF therapy

Other: Quality-of-Life Assessment
Ancillary studies




Primary Outcome Measures :
  1. Percentage of patients continuing therapy until intracranial tumor [ Time Frame: Up to 6 months ]
    Estimated using Wilson's method and a 95% confidence interval


Secondary Outcome Measures :
  1. Time to intracranial failure [ Time Frame: Up to 3 years ]
    Time to intracranial failure with death as a competing risk will be estimated using cumulative incidence function (CIF) and reported with a one-sided 95% confidence interval.

  2. Overall survival [ Time Frame: Up to 3 years ]
    Estimated using the Kaplan-Meier method.

  3. Rate of intracranial failure [ Time Frame: Up to 12 months ]
    Estimated using the cumulative incidence function

  4. Rate of decline in cognitive function [ Time Frame: Up to 12 months ]
    Measured by Hopkins Verbal Language Test

  5. Time to neurocognitive failure [ Time Frame: Up to 3 years ]
    Measured by Hopkins Verbal Language Test

  6. Neurocognitive failure-free survival [ Time Frame: Up to 3 years ]
    Measured by Hopkins Verbal Language Test

  7. Evaluate quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [ Time Frame: Up to 3 years ]
    Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (scale 1-4)

  8. Incidence of adverse events [ Time Frame: Up to 12 months ]
    Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  • Evidence of brain metastases on magnetic resonance imaging (MRI) of brain with and without contrast
  • History of other prior malignancy 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 received 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607682


Contacts
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Contact: Clinical Trials Information Program 800-811-8480 cip@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Trials Information Program    800-811-8480    cip@vanderbilt.edu   
Principal Investigator: Albert Attia, MD         
Sponsors and Collaborators
Albert Attia
NovoCure Ltd.
Investigators
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Principal Investigator: Albert Attia, MD Vanderbilt-Ingram Cancer Center

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Responsible Party: Albert Attia, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT03607682     History of Changes
Other Study ID Numbers: VICC THO 1747
NCI-2018-01428 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases