NCT01227954 · Phase 2 · COMPLETED
Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
This trial tests whether a more precise form of whole-brain radiation can spare the hippocampus, the brain's memory center, in people whose cancer has spread to the brain. Researchers are looking at how well it works and its effects on thinking. It is a Phase 2 trial, meaning early testing of effectiveness and safety, not yet proven or approved.
Eligibility criteria
INCLUSION CRITERIA: * Histologically or cytologically confirmed non-hematopoietic malignancy within the past 5 years * If histologic proof of malignancy is from > 5 years ago, then a more recent pathological confirmation is required (e.g., from systemic metastatic or brain metastasis) * Patients with metastasis of unknown primary tumor are permitted * Measurable brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast-enhanced MRI obtained within the past 30 days * Have not been or will not be treated with stereotactic radiosurgery (SRS) or surgical resection * These treatment options are allowed only at relapse * Patients who have brain metastases at initial presentation allowed and do not need to demonstrate 3 months of stable scans * At least 1 week since open biopsy * Karnofsky performance status 70-100% * Fertile patients must use effective contraception * Negative pregnancy test 2 weeks or less prior to study entry * Patients must be English proficient, with patients who speak English as a second language eligible EXCLUSION CRITERIA: * Small cell lung cancer or germ cell malignancy * Leptomeningeal metastases * Non-small cell lung cancer-associated brain metastases with ≥ 2 organ sites of extracranial metastases * Radiologic evidence of hydrocephalus * Serum creatinine > 1.4 mg/dL within 30 days prior to study entry * Pregnant or nursing * Contraindication to MRI imaging such as implanted metal devices or foreign bodies or severe claustrophobia * Severe, active co-morbidity including any of the following: * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * Transmural myocardial infarction within the past 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics * 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 * Uncontrolled, clinically significant cardiac arrhythmias * Prior radiotherapy to the brain * Plan for chemotherapy or targeted therapies during WBRT or during the subsequent 7 days
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2017-09-27