Title A Phase II of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases
IRB RTOG 0933
Hospital Main Campus
Phase Phase 2
- Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVTL-R) 4 months after hippocampal avoidance during whole-brain radiotherapy (HA-WBRT) for brain metastasis.
- Evaluate auditory and visual learning and memory, as assessed by 2 CogState tests (International Shopping List Test and One Card Learning Test), after HA-WBRT for brain metastasis.
- Compare psychometric properties of the 2 CogState tests to the HVLT-R for the assessment of memory decline after HA-WBRT for brain metastases.
- Evaluate health-related quality of life [as assessed by the Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR) and the Barthel Index of Activities of Daily Living (ADLs)] after HA-WBRT for brain metastasis.
- Evaluate time to radiographic progression after HA-WBRT for brain metastasis.
- Evaluate overall survival after HA-WBRT for brain metastasis.
- Evaluate adverse events according to CTCAE criteria.
- Evaluate predictive biomarkers of cognitive function.
- 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 (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis). Patients with metastasis of unknown primary tumor are permitted.
- Patients with measurable brain metastasis outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI obtained within 30 days prior to registration.
- Patients with measurable brain metastasis who have not been or will not be treated with SRS or surgical resection (Note: These treatment options are only permitted at relapse)
- History/physical examination within 30 days prior to registration
- Patients must fall into RTOG recursive partitioning analysis (RPA) class I or II (see Appendix IV)
- If an open biopsy is performed, the patient must be at least 1 week post-biopsy. This requirement is not necessary for stereotactic biopsies.
- Age ≥ 18 years
- Karnofsky performance status ≥ 70
- Patients must provide study-specific informed consent prior to study entry
- Women of childbearing potential and male participants must practice adequate contraception
- Women of childbearing potential must have a negative qualitative serum pregnancy test ≤2weeks prior to study entry
- Patients must be English proficient, with patients who speak English as a second language eligible
- Patients with leptomeningeal metastases
- Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy
- Patients with NSCLC-associated brain metastases with ≥ 2 sites of extracranial metastases
- Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- Serum creatinine > 1.4 mg/dl ≤ 30 days prior to study entry
- 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 evidence of 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 may be significantly teratogenic.