Status:
COMPLETED
Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Cognitive/Functional Effects
Metastatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in trea...
Detailed Description
OBJECTIVES: Primary * Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) at 4 months after hippocampal avoidance during whole-brain radiotherapy (HA-WBRT) in pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01227954
Start Date
March 1 2011
End Date
December 1 2016
Last Update
September 27 2017
Active Locations (63)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, United States, 85381
3
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
4
Arizona Oncology - Tucson
Tucson, Arizona, United States, 85704