Status:
UNKNOWN
Neurocognitive Outcome of Bilateral or Unilateral Hippocampal Avoidance WBRT With Memantine for Brain Metastases
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Metastatic Malignant Neoplasm to Brain
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Brain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness. Whole brain radio...
Eligibility Criteria
Inclusion
- Patients with a histologic diagnosis of non-hematopoietic malignancy and radiographic evidence of brain metastases
- Patients with brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI obtained within 30 days prior to registration
- Patients with brain metastasis who have not been or will not be treated with SRS, or have received SRS for ≤ 5 intracranial metastatic lesion(s)
- No evidence of diffuse leptomeningeal metastasis on gadolinium- enhanced MRI within 30 days prior registration
- Age ≥ 20 years
- Karnofsky Performance Status ≥ 60%
- Life expectancy of ≥ 6 months.
- Women of childbearing potential and male participants must practice adequate contraception
- Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent
Exclusion
- Prior radiotherapy to brain or radiosurgery to \> 5 intracranial metastatic lesion(s) or the biological equivalent dose in 2-Gy fractions was greater than 7.3Gy to 40% of the volume of bilateral hippocampus from prior radiosurgery
- Serum creatinine \> 2.0 mg/dL within 30 days prior registration
- Serum urea nitrogen \> 20 mg/dL within 30 days prior registration
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- 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:
- Uncontrolled active infection requiring intravenous antibiotics at the time of registration
- Transmural myocardial infarction ≤ 6 months prior to registration
- Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration
- Life-threatening uncontrolled clinically significant cardiac arrhythmias
- 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 psychiatric disorder
- Will receive any other investigational agent or chemotherapy during WBRT
- Current use of Memantine HCL or Allergy to Memantine HCL
- 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
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04801342
Start Date
April 1 2021
End Date
February 28 2025
Last Update
March 17 2021
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100