Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02831959 : Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. 18 years of age and older

2. Life expectancy of ? 3 months

3. New diagnosis of brain metastases from a histologically or cytologically confirmed
primary or metastatic NSCLC tumor within 5 years of registration on the study. If the
original histological proof of malignancy is greater than 5 years, then pathological
confirmation is required (i.e.: from extra-cranial or intracranial disease).

4. Karnofsky performance status (KPS) ? 70

5. 1 inoperable brain metastasis or 2- 10 brain lesions per screening MRI, confirmed by
contrast enhanced MRI amenable to SRS according to the following criteria:

1. largest tumor volume < 10 cc

2. longest tumor diameter < 3 cm

3. Cumulative volume of all tumors ? 15 cc

6. At least one measurable lesion per RANO-BM (Response Assessment in Neuro-Oncology
Brain Metastases) Criteria for brain metastasis

7. 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 TTFields.

8. Able to operate the NovoTTF-100M device independently or with the help of a caregiver

9. Clinical trials prior to enrollment are allowed, as long as no brain directed therapy
was included (current treatment trials are exclusionary)

Exclusion Criteria:

1. Patients who are known to have somatic tumor mutations in the following genes, for
which targeted agents are available that directly affect the treatment of brain
metastasis: Anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR),
ROS-1 proto-oncogene, and proto-oncogene B-RAF

2. Patients who have a single, operable brain metastasis

3. Patients with significant edema leading to risk of brain herniation

4. Patients with midline shift > 10mm

5. Patients with intractable seizures

6. Leptomeningeal metastases

7. Recurrent brain metastases

8. Prior WBRT for newly diagnosed brain metastases

9. Severe comorbidities:

1. Clinically-significant inadequate hematological, hepatic and renal function,
defined as: Neutrophil count < 1.5 x 10 9/L and platelet count < 100 x 10^9/L;
bilirubin > 1.5 x upper limit of normal (ULN); aspartate transaminase (AST)
and/or alanine aminotransferase (ALT) > 2.5 x ULN or > 5 x ULN if 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
or that is not stable

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 patient's ability to
understand or comply with the requirements of the study or to provide consent

10. Implantable electronic medical devices in the brain

11. Known allergies to medical adhesives or hydrogel

12. Currently pregnant or breastfeeding

13. Concurrent brain directed therapy (beyond SRS and NovoTTF-100M as per protocol)
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02831959      |      Link to official Clinicaltrials.gov listing
Locations
Innsbruck,
Austria

Facility: Medizinische Universität Innsbruck
Investigator: Christian Freyschlag, MD
Contact: Christian Freyschlag, MD Phone: +43 51250427453
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Winnipeg, Manitoba
Canada

Facility: Cancercare Manitoba
Investigator: Saranya Kakumanu, MD
Contact:
Email not avaialable

Montreal, Quebec
Canada

Facility: Notre-Dame Hospital CHUM
Investigator: David Roberge, MD
Contact: Diane Trudel, RN Phone: 514-890-8000
Email not avaialable

Montreal, Quebec
Canada

Facility: Jewish General Hospital
Investigator: Thierry Muanza, MD
Contact: Thierry Muanza Phone: (514)-340-8288
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Montréal, Quebec
Canada

Facility: Le CIUSSS de I'Est-de-L'ile de Montreal
Investigator: Pierre Chabot, MD
Contact: Veronique Tran Phone: (514)-252-3400
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Sherbrooke, Quebec
Canada

Facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
Investigator: David Mathieu, MD
Contact: Anick Champoux Phone: (819)-346-1110
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Lille,
France

Facility: University Hospital Lille
Investigator: Emilie Le Rhun, MD
Contact: Camille Gombert Phone: + 33 320446611
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Avellino,
Italy

Facility: A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità
Investigator: Cesaer Guida, MD
Contact: Cesare Guida Phone: +39 0825 203937
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Lecco,
Italy

Facility: Azienda Socio Sanitaria Territoriale di Lecco
Investigator: Andrea Salmaggi, MD
Contact: Andrea Salmaggi, MD Phone: +39 3333593768
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Bydgoszcz,
Poland

Facility: Marek Harat Private Practice, Neurosurgery and Radiation Oncology
Investigator: Maciej Harat, MD
Contact: Maciej Harat, MD Phone: +48 600411874
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Gda?sk,
Poland

Facility: University Clinical Center
Investigator: Ewa Szutowicz-Zieli?ska, MD
Contact: Agnieszka Kukowska Phone: +48 583492214
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Birmingham, Alabama
Facility: University of Alabama at Birmingham Comprehensive Cancer Center
Investigator: John Fiveash, MD
Contact: Melissa Deakle
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Phoenix, Arizona
Facility: Mayo Clinic Phoenix
Investigator: Terence Sio, MD
Contact: Clinical Trials Referral Office Phone: 855-776-0015
Email not avaialable

Phoenix, Arizona
Facility: Mayo Clinic - Phoenix
Investigator: Terence Sio, MD
Contact: Terence Sio, MD Phone: 855-776-0015
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Tucson, Arizona
Facility: University of Arizona Cancer Center
Investigator: Hani Babiker, MD
Contact: Crystal Placencia Phone: 520-694-1231
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Los Angeles, California
Facility: Keck Medical Center of USC
Investigator: Thomas Chen, MD
Contact: Sandy Leong Phone: 323-442-7532
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Los Angeles, California
Facility: Cedars-Sinai Medical Center
Investigator: Jethro Hu, MD
Contact: Jaime Richardson, RN Phone: 310-423-2133
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Orange, California
Facility: Chao Family Comprehensive Cancer Center
Investigator: Jose Carrillo, MD
Contact: Jinah Chung Phone: 877-827-8839
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Orange, California
Facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
Investigator: Venita Williams, MD
Contact: Martha French Phone: 714-734-6200
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Redwood City, California
Facility: Kaiser Permanente Redwood City
Investigator: Scott Peak, MD
Contact: Nancy Mendelssohn, CCRC Phone: 650-299-4165
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Sacramento, California
Facility: Kaiser Permanente - Sacramento
Investigator: Enrico Lallana, MD
Contact: Renee Cunanan Phone: 916-973-4885
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Fairfield, Connecticut
Facility: Associated Neurologists of Southern CT
Investigator: Nicholas Blondin, MD
Contact: Micah Sy Phone: 203-333-1151
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Gainesville, Florida
Facility: University of Florida
Investigator: David Tran, MD
Contact: Sarah Andrews, RN Phone: 352-273-7981
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Jacksonville, Florida
Facility: Mayo Clinic
Investigator: Daniel Trifiletti, MD
Contact: Clinical Trials Referral Office Phone: 855-776-0015
Email not avaialable

Miami, Florida
Facility: Miami Cancer Institute
Investigator: Minesh Mehta, MD
Contact: Jessica Gonzalez-Salas Phone: 786-527-8112
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Orlando, Florida
Facility: UF Health Cancer Center
Investigator: Naren Ramakrishna, MD
Contact: Robert P. Ferry Phone: 321-841-1077
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Atlanta, Georgia
Facility: Piedmont Brain Tumor Center
Investigator: Adam Nowlan, MD
Contact: Shirley Elkins Phone: 404-605-2050
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Chicago, Illinois
Facility: Robert H. Lurie Comprehensive Cancer Center - Northwestern University
Investigator: Priya Kumthekar, MD
Contact: Rachel Lukas Phone: 312-695-1371
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Maywood, Illinois
Facility: Loyola University Medical Center
Investigator: Abhishek Solanki, MD
Contact: Beth Chiappetta Phone: 708-216-2568
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Warrenville, Illinois
Facility: CDH-Delnor Health System
Investigator: Vinai Gondi, MD
Contact: Donald Smith, MS, CCRC Phone: 603-352-5360
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Edgewood, Kentucky
Facility: St. Elizabeth Healthcare Cancer Care Center
Investigator: Robert Albright, MD
Contact: Darla Hehman, RN Phone: 859-301-5473
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Louisville, Kentucky
Facility: University of Louisville
Investigator: Eric Burton, MD
Contact: Erika Hargis Phone: 502-217-5244
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New Orleans, Louisiana
Facility: Tulane Cancer Center
Investigator: Steven DiBiase, MD
Contact: Elise M Tatje Phone: 504-988-6121
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New Orleans, Louisiana
Facility: Ochsner Health System
Investigator: Marcus Ware, MD, PhD
Contact: Jessica Henry Phone: 504-842-8769
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Boston, Massachusetts
Facility: Tufts Medical Center
Investigator: Suriya Jeyapalan, MD
Contact: Leanne Ianniello Phone: 617-636-2883
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Boston, Massachusetts
Facility: Beth Israel Deaconess Medical Center
Investigator: Eric Wong, MD
Contact: Christina Ng Phone: 617-667-1832
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Troy, Michigan
Facility: 21st Century Oncology
Investigator: Vito John Antonucci, MD
Contact: Paulette Palazzolo Phone: 248-672-7745
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Minneapolis, Minnesota
Facility: John Nasseff Neuroscience Institute ANW Brain Tumor Center
Investigator: John Trusheim, MD
Contact: Meghan Hultman Phone: 612-863-3308
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Minneapolis, Minnesota
Facility: Masonic Cancer Clinic
Investigator: Emil Lou, MD
Contact: Kim Sieckowski Phone: 612-626-4495
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Rochester, Minnesota
Facility: Mayo Clinic
Investigator: Yolanda Garces, MD
Contact: Clinical Trials Referral Office Phone: 855-776-0015
Email not avaialable

Jackson, Mississippi
Facility: University of Mississippi Medical Center
Investigator: Mark Anderson, MD
Contact: Jennifer Barnes Phone: 601-815-4540
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New York, New York
Facility: Weil Cornell Medical College/New York Presbyterian Hospital
Investigator: Ronald Scheff, MD
Contact: Amanda De Laurentiis Phone: 646-962-9349
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New York, New York
Facility: Icahn School of Medicine at Mount Sinai
Investigator: Isabelle Germano, MD
Contact: Johnny Chan Phone: 212-824-7861
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New York, New York
Facility: Nyph/Cumc
Investigator: Teri Kreisl, MD
Contact: David Cieremans Phone: 212-304-5570
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Chapel Hill, North Carolina
Facility: UNC - Lineberger Comprehensive Cancer Center
Investigator: Simon Khagi, MD
Contact: Correi Moore Phone: 919-966-4432
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Greenville, North Carolina
Facility: East Carolina University
Investigator: Clinton Leinweber, MD
Contact: Kaitlyn Walker Phone: 252-744-0456
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Greenville, North Carolina
Facility: Vidant Medical Center
Investigator: K. Stuart Lee, MD
Contact: Kim Guillemette Phone: 252-902-4243
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Winston-Salem, North Carolina
Facility: Wake Forest Health
Investigator: Michael Chan, MD
Contact: Shirley Coe Phone: 336-713-6505
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Cleveland, Ohio
Facility: Cleveland Clinic
Investigator: Manmeet Ahluwalia, MD
Contact: Manmeet Ahluwalia, MD Phone: 216-444-6145
Email not avaialable

Danville, Pennsylvania
Facility: Geisinger Medical Center
Investigator: Scott Turner, MD
Contact: Angela Whitmire Phone: 570-214-2834
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Philadelphia, Pennsylvania
Facility: Hospital of the University of Pennsylvania
Investigator: Steven Brem, MD
Contact: Scott Levy Phone: 215-662-6832
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Pittsburgh, Pennsylvania
Facility: Alleghany Health Network
Investigator: Stephen Karlovits, MD
Contact: Park Bogan Phone: 412-359-6883
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Providence, Rhode Island
Facility: Rhode Island Hospital
Investigator: Alexander Mohler, MD
Contact: Wendy Turchetti, RN Phone: 401-444-7698
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Germantown, Tennessee
Facility: West Cancer Center
Investigator: Matthew Ballo, MD
Contact: Rachel Adams, CCRP Phone: 910-683-0055
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Nashville, Tennessee
Facility: Vanderbilt-Ingram Cancer Center
Investigator: Alfred Attia, MD
Contact: Alfred Attia, MD
Email not avaialable

Austin, Texas
Facility: Texas Oncology - Austin
Investigator: Morris Groves, MD
Contact: Kristen Brueggemann Phone: 512-421-4100
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Houston, Texas
Facility: The University of Texas M.D. Anderson Cancer Center
Investigator: Jing Li, MD
Contact: Bobby Korah Phone: 713-745-8308
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Houston, Texas
Facility: Houston Methodist Hospital
Investigator: Ivo Tremont, MD
Contact: Julie Baskin Phone: 713-441-3800
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Longview, Texas
Facility: Texas Oncology-Longview Cancer Center
Investigator: Bernard Taylor, MD
Contact: Cristy McCullough Phone: 903-234-7047
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Lubbock, Texas
Facility: Joe Arrington Cancer Research and Treatment Center
Investigator: Paul Anderson, MD
Contact: Sonia Salas Phone: 806-725-8068
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Temple, Texas
Facility: Baylor Scott & White Health
Investigator: Ekokobe Fonkem, MD
Contact: Dedra Preece, CRC Phone: 254-771-4826
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Charlottesville, Virginia
Facility: University of VA Health Sciences Center
Investigator: Jason Sheehan, MD
Contact: Joe Farrar, BS Phone: 434-982-6455
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Norfolk, Virginia
Facility: Sentara Health
Investigator: Wylie Zhu, MD
Contact: Rebecca M Lee Phone: 757-388-4393
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Milwaukee, Wisconsin
Facility: Aurora Research Institute - St. Luke's Medical Center
Investigator: George Bobustuc, MD
Contact: Kate McPolin Phone: 414-385-7125
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