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.]

NCT02393131 : Neurocognitive Outcome of Conformal WBRT w/wo Hippocampal Avoidance for Brain Metastases
PhaseN/A
AgesMin: 20 Years Max: N/A
Eligibility
Inclusion criteria:

To be eligible for inclusion, patients must fulfill the following criteria:

1. Patients with a histologic diagnosis of non-hematopoietic malignancy and radiographic
evidence of brain metastases

2. Patients with brain metastasis outside a 5-mm margin around either hippocampus on
gadolinium contrast enhanced MRI obtained within 30 days prior to registration

3. Patients with brain metastasis who have not been or will not be treated with
stereotactic radiosurgery (SRS) or have ??received SRS for?= 5 intracranial
?metastatic ?lesions

4. No evidence of leptomeningeal metastasis on gadolinium-enhanced MRI within 30 days
prior registration

5. Age = 20 years

6. Karnofsky Performance Status = 60%

7. Life expectancy of = 4 months.

8. Women of childbearing potential and male participants must practice adequate
contraception

9. Patients must be able to comply with the study protocol and follow-up schedules and
provide study- specific informed consent

Exclusion criteria:

Patients fulfill any of the following criteria will be excluded from this trial

1. Prior radiotherapy to brain or SRS to > 5 intracranial metastatic lesion(s) or the
biological equivalent dose in 2-Gy fractions was greater than 7.3 Gy to 40% of the
volume of bilateral hippocampus from prior SRS

2. Serum creatinine > 2.0 mg/dL within 30 days prior registration

3. Contraindication to MRI such as implanted metal devices or foreign bodies, severe
claustrophobia

4. Patients with leptomeningeal metastases

5. Severe, active comorbidities which, in the judgment of the investigator, would make
the patient inappropriate for entry into this study or interfere significantly with
the proper assessment of safety and adverse events of the protocol, or limit
compliance with study requirements, defined as follows:

1. Uncontrolled active infection requiring intravenous antibiotics at the time of
registration

2. Transmural myocardial infarction = 6 months prior to registration

3. Unstable angina or congestive heart failure requiring hospitalization = 6 months
prior to registration

4. Life-threatening uncontrolled clinically significant cardiac arrhythmias

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

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

7. Uncontrolled psychiatric disorder

8. Uncontrolled, clinically significant cardiac arrhythmias

6. Will receive any other investigational agent or chemotherapy and/or target therapies
during WBRT

7. 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 may be significantly
teratogenic
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02393131      |      Link to official Clinicaltrials.gov listing
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