Clinical Trial Details
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[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.]

NCT01731704 : Neurocognitive Outcomes In Patients Treated With Radiotherapy For Five Or More Brain Metastases
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Pathologically (histologically or cytologically) proven diagnosis of a
non-hematopoietic malignancy other than small cell lung cancer and germ cell
malignancy within 5 years of registration. If the original histologic proof of
malignancy is greater than 5 years, then pathological confirmation is required (e.g.
from extra- or intra-cranial disease).

- If an open biopsy is performed, the patient must be at least one week post biopsy.
This requirement does not apply to patients who undergo stereotactic biopsies.

- Patients with ?5 measurable brain metastases on a diagnostic-quality
contrast-enhanced magnetic resonance imaging (MRI) obtained within 30 days prior to
registration.

- Patients with ?10 cc largest tumor volume, and ?15 cc total tumor volume.

- History/physical examination within 30 days prior to registration.

- Age ?18 years.

- Karnofsky performance status ?70 (RTOG recursive partitioning analysis (RPA) Class I
& II).

- Minimum pre-treatment oNCF score ?70.

- Patients must provide study-specific informed consent prior to study entry.

- Women of child-bearing age must have a negative, quantitative serum pregnancy test
?14 days prior to study entry, or have a documented reason why such a test is not
necessary (e.g. history of tubal ligation).

- Patients must be able to speak and read English fluently (required for the use of
online NCF testing).

- Patients must demonstrate basic computer literacy skills and have access to an
internet terminal (required for the use of online NCF testing).

Exclusion Criteria:

- Clinical (e.g. multiple new cranial nerve deficits in the absence of obvious
radiographic disease to explain symptoms) or radiographic evidence of leptomeningeal
disease.

- Patients with measurable brain metastasis(es) resulting from small cell lung cancer
and/or germ cell malignancy.

- No documentation of prior cytotoxic or other therapy for malignancy if such therapy
was previously received. Note: This does not apply to patients with synchronous
metastases at initial diagnosis.

- Contraindication to MR imaging, such as implanted metal devices or foreign bodies,
severe claustrophobia, or contraindications to contrast agent administration.

- Estimated glomerular filtration rate (eGFR) <60 within 6 weeks prior to registration.
• Prior radiation therapy to the brain. • Severe, active co-morbidity, defined as
follows:

- Unstable angina, and/or congestive heart failure requiring hospitalization
within the last 6 months.

- Transmural myocardial infarction within the last 6 months. - Acute bacterial or
fungal infection requiring intravenous antibiotics at the time of registration.

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization, or precluding study therapy at the time of
registration.

- Uncontrolled, clinically significant cardiac arrhythmias. - Radiologic or
clinical evidence of hydrocephalus, or history of previously treated
hydrocephalus.

- Women of childbearing potential and male participants who are sexually active and not
willing/able to use medically acceptable forms of contraception; this exclusion is
necessary because the radiation treatment involved in this study is potentially
teratogenic
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01731704      |      Link to official Clinicaltrials.gov listing
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