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Effect of TTFields (150kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment (COMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01755624
Recruitment Status : Unknown
Verified July 2016 by NovoCure Ltd..
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : September 21, 2016
Information provided by (Responsible Party):
NovoCure Ltd.

Brief Summary:
The study is a prospective, randomly controlled phase II trial, designed to test the efficacy, safety and neurocognitive outcomes of a medical device, the NovoTTF-100A, in the treatment of NSCLC patients with controlled systemic disease, following optimal standard local treatment for 1-5 brain metastases (BM). The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Condition or disease Intervention/treatment Phase
1-5 Brain Metastases From Non-Small Cell Lung Cancer Device: NovoTTF-100A device Other: Best Standard of Care Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of TTField Therapy (150 kHz) Versus Supportive Care in Non-small Cell Lung Cancer Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment
Study Start Date : January 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NovoTTF-100A device
Patients will be treated continuously with the NovoTTF-100A device. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
Device: NovoTTF-100A device
Active Comparator: Best Standard of Care
Patients will be treated as the best known standard of care for Non-Small Cell Lung Cancer metastatic to the brain.
Other: Best Standard of Care

Primary Outcome Measures :
  1. Time to Local and Distant Progression in The Brain [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
  2. 6-Month Disease Control Rate in The Brain [ Time Frame: 2 years ]
  3. Neurocognitive Function (MMSE and HVLT) [ Time Frame: 2 years ]
  4. Quality of life (QLQ-C30 and BN-20) [ Time Frame: 2 years ]
  5. Overall (systemic) Progression-Free Survival (RECIST Criteria) [ Time Frame: 2 years ]
  6. Adverse Events Severity and Frequency [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 18 years of age and older
  2. Life expectancy of ≥ 3 months
  3. Performance status WHO 0-2 (may be assessed under steroid therapy)
  4. New diagnosis of BM from a histologically or cytologically confirmed primary or metastatic NSCLC tumor, meeting 1 of the following criteria:

    1. Stable systemic cancer for the last 3 months (achieved by surgery, radiotherapy, or chemotherapy), defined as absence of symptomatic and radiological progression, according to RECIST Criteria
    2. Asymptomatic synchronous primary tumor (treatable by surgery, radiotherapy, or chemotherapy)
  5. BM biopsy required if no extracranial tumor (unknown primary tumor) OR extracranial diagnosis made more than 4 years previously
  6. Must have one to five brain lesions, confirmed by contrast enhanced MRI, all amenable either surgical resection, or to SRS according to the following criteria:

    1. Largest diameter ≤ 3.5 cm for single metastasis
    2. Largest diameter ≤ 2.5 cm for 2 to 5 metastases
  7. Stable or decreasing dose of steroids for at least 5 days before screening
  8. Patients must be receiving optimal therapy for their extracranial disease according to local practice at each center. Patients may continue on systemic therapy while receiving TTField therapy

Exclusion Criteria:

  1. Infratentorial metastases
  2. Leptomeningeal metastases
  3. Patients who previously received WBRT or SRS for BM (prior resection is allowed as long as any remaining tumor is treated under the protocol)
  4. Significant co-morbidity which is expected to affect patient's prognosis or ability to receive optimal systemic therapy:

    1. Inadequate and clinically relevant hematological, hepatic and renal abnormalities defined as: Neutrophil count > 1.5 x 10 9/L and platelet count > 100 x 10 9/L; bilirubin < 1.5 x ULN; AST and/or ALT < 2.5 x ULN or < 5 x ULN is patient has documented liver metastases; and serum creatinine < 1.5 x ULN
    2. 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).
    3. 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
    4. History of cerebrovascular accident (CVA) within 6 months prior to randomization
    5. Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
    6. History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent
    7. Pregnant, or women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception
  5. Unable to operate the NovoTTF-100A device independently or with the help of a caregiver
  6. Implantable electronic medical devices in the brain
  7. Known allergies to medical adhesives or hydrogel
  8. Concurrent brain directed therapy (beyond SRS, surgery and TTField therapy as per protocol)

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 identifier (NCT number): NCT01755624

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Czech Republic
Na Homolce Hospital
Prague, Czech Republic
Hopital Neurologique Pierre Wertheimer
Lyon, France
Centre Paul Strauss
Strasbourg, France
Ospedale Lecco
Lecco, Italy
Medical University of Gdańsk
Gdańsk, Poland
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Poland
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain
Sponsors and Collaborators
NovoCure Ltd.
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Principal Investigator: Andrea Salamaggi, MD Lecco General Hospital
Pless, M., et al. A Phase II Study of Tumor Treating Fields (TTFields) in Combination with Pemetrexed for Advanced Non Small Cell Lung Cancer (NSCLC). in ESMO 2010. 2010. Milan: Ann Oncol.
Weinberg, U., et al. An Open Label Pilot Study of Tumor Treating Fields (TTFields) in Combination with Pemetrexed for Advanced Non-small Cell Lung Cancer (NSCLC). in ERS Annual Congress. 2010. Publisher: Abstract 363.

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Responsible Party: NovoCure Ltd. Identifier: NCT01755624    
Other Study ID Numbers: EF-21
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: July 2016
Keywords provided by NovoCure Ltd.:
Non-Small Cell Lung Cancer
Brain metastases
Minimal toxicity
Tumor Treating Fields
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases