A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases
- Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised
(HVTL-R) at 4 months after hippocampal avoidance during whole-brain radiotherapy
(HA-WBRT) in patients with 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 in these
- Compare psychometric properties of the 2 CogState tests to the HVLT-R for the
assessment of memory decline after HA-WBRT in these patients.
- 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 in these patients.
- Evaluate time to radiographic progression after HA-WBRT in these patients.
- Evaluate overall survival of these patients after HA-WBR.
- Evaluate the adverse events of HA-WBR.
- Evaluate predictive biomarkers of cognitive function.
OUTLINE: This is a multicenter study.
Patients undergo 10 fractions of intensity-modulated whole-brain radiotherapy (WBRT),
avoiding hippocampal (HA) regions, once daily, 5 days a week, for 2-2½ weeks.
Patients neurocognitive functions (delayed recall, auditory and visual learning, and memory)
are evaluated by the Hopkins Verbal Learning Test-Revised (HVTL-R), The One Card Learning
Test (OCLT), and the International Shopping List Test (ISLT) at baseline and periodically
Patients may undergo serum, plasma, or whole blood collection at baseline and at 4 months
after completion of HA-WBRT for correlative studies.
Patients may complete the Functional Assessment of Cancer Therapy with Brain Subscale
(FACT-BR), and the Barthel Index of Activities of Daily Living (ADLs) quality-of-life
questionnaires at baseline and periodically during study and follow up.
After completion of study therapy, patients are followed up periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Delayed recall at 4 months as measured by the Hopkins Verbal Learning Test-Revised
Within 2 weeks prior to treatment, 4 months after HA-WBRT
Minesh P. Mehta, MD
Ohio State University Comprehensive Cancer Center
United States: Federal Government
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Methodist Cancer Center at Methodist Hospital||Indianapolis, Indiana 46202|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|Veterans Affairs Medical Center - Long Beach||Long Beach, California 90822|
|Rush University Medical Center||Chicago, Illinois 60612-3824|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|CCOP - Virginia Mason Research Center||Seattle, Washington 98101|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|
|Baptist-South Miami Regional Cancer Program||Miami, Florida 33176|
|Baptist Cancer Institute - Jacksonville||Jacksonville, Florida 32207|
|Adena Regional Medical Center||Chillicothe, Ohio 54601|
|Cancer Care Northwest - Spokane South||Spokane, Washington 99202|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center||Los Angeles, California 90048-1865|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|St. Barnabas Medical Center Cancer Center||Livingston, New Jersey 07039|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Virginia Commonwealth University Massey Cancer Center||Richmond, Virginia 23298-0037|
|Huntsman Cancer Institute at University of Utah||Salt Lake City, Utah 84112|
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Piedmont Hospital||Atlanta, Georgia 30309|
|OSF St. Francis Medical Center||Peoria, Illinois 61637|
|Providence Cancer Center at Providence Portland Medical Center||Portland, Oregon 97213-2967|
|Bryn Mawr Hospital||Bryn Mawr, Pennsylvania 19010|
|Lankenau Cancer Center at Lankenau Hospital||Wynnewood, Pennsylvania 19096|
|UAB Comprehensive Cancer Center||Birmingham, Alabama 35294|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|
|Billings Clinic - Downtown||Billings, Montana 59107-7000|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|York Cancer Center at Apple Hill Medical Center||York, Pennsylvania 17405|
|Jon and Karen Huntsman Cancer Center at Intermountain Medical Center||Murray, Utah 84157|
|Val and Ann Browning Cancer Center at McKay-Dee Hospital Center||Ogden, Utah 84403|
|Radiological Associates of Sacramento Medical Group, Incorporated||Sacramento, California 95815|
|Regional Cancer Center - Erie||Erie, Pennsylvania 16505|
|Florida Cancer Center - Palatka||Palatka, Florida 32177|
|Center for Cancer Care at Goshen General Hospital||Goshen, Indiana 46526|
|NSMC Cancer Center - Peabody||Peabody, Massachusetts 01960|
|New York Oncology Hematology, PC at Albany Regional Cancer Care||Albany, New York 12208|
|Southwest General Health Center||Middleburgh Heights, Ohio 44130|
|Arizona Center for Cancer Care - Peoria||Peoria, Arizona 85381|
|Willamette Valley Cancer Center - Eugene||Eugene, Oregon 97401|
|Texas Oncology, PA at Harris Center HEB||Bedford, Texas 76022|
|Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital||Fort Worth, Texas 76104|
|Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land||Sugar Land, Texas 77479|
|Nebraska Medical Center||Omaha, Nebraska 68198|
|Arizona Oncology - Tucson||Tucson, Arizona 85704|
|Adams Cancer Center||Gettysburg, Pennsylvania 17325|
|Memorial Hermann Hospital - Memorial City||Houston, Texas 77024|