Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Completed · Phase 2

Conditions studied: Cognitive/Functional Effects, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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 treating patients with brain metastases.

Key facts

Study ID

NCT01227954

Run by

Radiation Therapy Oncology Group

People needed

113

Starts

2011-03-01

Expected to finish

2016-12-01

Last updated by the study team

2017-09-27

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Center for Cancer Care - Peoria — Peoria, Arizona, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Arizona Oncology - Tucson — Tucson, Arizona, United States
• Arizona Cancer Center at University of Arizona Health Sciences Center — Tucson, Arizona, United States
• Veterans Affairs Medical Center - Long Beach — Long Beach, California, United States
• Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center — Los Angeles, California, United States
• Radiological Associates of Sacramento Medical Group, Incorporated — Sacramento, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• University of Miami Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States
• Baptist-South Miami Regional Cancer Program — Miami, Florida, United States
• Florida Cancer Center - Palatka — Palatka, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Center for Cancer Care at Goshen General Hospital — Goshen, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Methodist Cancer Center at Methodist Hospital — Indianapolis, Indiana, United States
• Greenebaum Cancer Center at University of Maryland Medical Center — Baltimore, Maryland, United States
• NSMC Cancer Center - Peabody — Danvers, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis — St Louis, Missouri, United States
• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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