Clinical Trial Details
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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
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)
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