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. Graded Prognostic Assessment (GPA) score ? 2.0

6. 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

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

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 TTFields.

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

10. 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. Infratentorial metastases

7. Leptomeningeal metastases

8. Recurrent brain metastases or brain metastases previously treated with surgery and/or
radiosurgery and/or brain radiotherapy

9. Prior surgical resection or WBRT for newly diagnosed brain metastases (needle biopsy
for diagnosis establishment is allowed)

10. 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

11. Implantable electronic medical devices in the brain

12. Known allergies to medical adhesives or hydrogel

13. Currently pregnant or breastfeeding

14. 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
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
Click HERE to send email to this center

Fairfield, Connecticut
Facility: Associated Neurologists of Southern CT
Investigator: Nicholas Blondin, MD
Contact: Micah Sy Phone: 203-333-1151
Click HERE to send email to this center

Atlanta, Georgia
Facility: Piedmont Brain Tumor Center
Investigator: Adam Nowlan, MD
Contact: Shirley Elkins Phone: 404-605-2050
Click HERE to send email to this center

Warrenville, Illinois
Facility: CDH-Delnor Health System
Investigator: Vinai Gondi, MD
Contact: Donald Smith, MS, CCRC Phone: 603-352-5360
Click HERE to send email to this center

Louisville, Kentucky
Facility: University of Louisville
Investigator: Eric Burton, MD
Contact: Erika Hargis Phone: 502-217-5244
Click HERE to send email to this center

Boston, Massachusetts
Facility: Tufts Medical Center
Investigator: Suriya Jeyapalan, MD
Contact: Amy Quinkert Phone: 617-636-8589
Click HERE to send email to this center

Troy, Michigan
Facility: 21st Century Oncology
Investigator: Vito John Antonucci, MD
Contact: Paulette Palazzolo Phone: 248-672-7745
Click HERE to send email to this center

Minneapolis, Minnesota
Facility: John Nasseff Neuroscience Institute ANW Brain Tumor Center
Investigator: John Trusheim, MD
Contact: Meghan Hultman Phone: 612-863-3308
Click HERE to send email to this center

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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Winston-Salem, North Carolina
Facility: Wake Forest Health
Investigator: Michael Chan, MD
Contact: Shirley Coe Phone: 336-713-6505
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Germantown, Tennessee
Facility: West Cancer Center
Investigator: Matthew Ballo, MD
Contact: Rachel Adams, CCRP Phone: 910-683-0055
Click HERE to send email to this center

Houston, Texas
Facility: The University of Texas M.D. Anderson Cancer Center
Investigator: Jing Li, MD
Contact: Victoria Cox Phone: 713-792-4928
Click HERE to send email to this center

Charlottesville, Virginia
Facility: University of VA Health Sciences Center
Investigator: Jason Jason Sheehan, MD
Contact: Joe Farrar, BS Phone: 434-982-6455
Click HERE to send email to this center




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