Clinical Trial Details
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NCT01755624 : Effect of NovoTTF-100A in Non-small Cell Lung Cancer (NSCLC) Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment (COMET)
PhasePhase 2
AgesMin: 18 Years Max: N/A
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

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

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
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