Effect of NovoTTF-100A in Non-small Cell Lung Cancer (NSCLC) Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by NovoCure Ltd.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT01755624
First received: December 19, 2012
Last updated: March 17, 2014
Last verified: January 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of TTField Therapy Versus Supportive Care in Non-small Cell Lung Cancer Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Time to Local and Distant Progression in The Brain [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 6-Month Disease Control Rate in The Brain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Neurocognitive Function (MMSE and HVLT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life (QLQ-C30 and BN-20) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall (systemic) Progression-Free Survival (RECIST Criteria) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Adverse Events Severity and Frequency [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755624

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Matthias Preusser, MD    +43 1 40400 4457    matthias.preusser@meduniwien.ac.at   
Principal Investigator: Matthias Preusser, MD         
Czech Republic
Na Homolce Hospital Recruiting
Prague, Czech Republic
Contact: Josef Vymazal, MD    +420 257 273 200    Josef.Vymazal@homolka.cz   
Principal Investigator: Josef Vymazal, MD         
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Carmit Ben Harosh    +972 3 697 4397    carmitbh@tasmc.health.gov.il   
Principal Investigator: Andrew Kanner, MD         
Italy
Ospedale Lecco Recruiting
Lecco, Italy
Contact: Andrea Salmaggi, MD       a.salmaggi@ospedale.lecco.it   
Principal Investigator: Andrea Salmaggi, MD         
Spain
Hospital 12 de Octubre Recruiting
Madrid, Spain
Contact: Santiago Ponce Aix       santiago.ponce@salud.madrid.org   
Principal Investigator: Santiago Ponce Aix, MD         
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Principal Investigator: Josef Vymazal, MD Na Homolce, Prague
Principal Investigator: Andrew Kanner, MD Tel Aviv Medical Center
Principal Investigator: Matthias Pruesser, MD University of Vienna
Principal Investigator: Andrea Salamaggi, MD Lecco General Hospital
  More Information

Publications:

Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT01755624     History of Changes
Other Study ID Numbers: EF-21
Study First Received: December 19, 2012
Last Updated: March 17, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by NovoCure Ltd.:
Non-Small Cell Lung Cancer
NSCLC
Brain metastases
Treatment
Minimal toxicity
TTFields
TTF
Tumor Treating Fields
NovoCure

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014