A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases
OBJECTIVES:
Primary
- 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.
Secondary
- 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
patients.
- 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
during study.
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.
Interventional
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
No
Minesh P. Mehta, MD
Study Chair
Ohio State University Comprehensive Cancer Center
United States: Federal Government
RTOG-0933
NCT01227954
March 2011
Name | Location |
---|---|
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 |