Critères d'inclusion : 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:
- largest tumor volume < 10 cc
- longest tumor diameter < 3 cm
- 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)
Critères de non-inclusion : 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:
- 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
- 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).
- 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.
- History of cerebrovascular accident (CVA) within 6 months
prior to randomization or that is not stable
- Active infection or serious underlying medical condition that
would impair the ability of the patient to received protocol
therapy
- 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 10. 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)