Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
NCT ID: NCT01227954
Last Updated: 2017-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2011-03-31
2016-12-31
Brief Summary
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PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases.
Detailed Description
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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 patients with brain metastasis.
Secondary
* Evaluate auditory and visual learning and memory, as assessed by two 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WBRT with Hippocampal Avoidance
Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
intensity-modulated radiation therapy
30 Gy in 10 fractions to the whole brain using intensity-modulated radiation therapy excluding the hippocampal avoidance area. Bilateral hippocampal contours manually generated on the fused planning MRI CT image set by the treating physician according to protocol-specified contouring instructions. Hippocampal avoidance regions generated by three-dimensionally expanding the hippocampal contours by 5 mm.
Interventions
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intensity-modulated radiation therapy
30 Gy in 10 fractions to the whole brain using intensity-modulated radiation therapy excluding the hippocampal avoidance area. Bilateral hippocampal contours manually generated on the fused planning MRI CT image set by the treating physician according to protocol-specified contouring instructions. Hippocampal avoidance regions generated by three-dimensionally expanding the hippocampal contours by 5 mm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Minesh P. Mehta, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland Medical Systems
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
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
Billings Clinic - Downtown
Billings, Montana, United States
Nebraska Medical Center
Omaha, Nebraska, United States
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Southwest General Health Center
Middleburg Heights, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Regional Cancer Center - Erie
Erie, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States
Memorial Hermann Hospital - Memorial City
Houston, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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References
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Gondi V, Pugh SL, Tome WA, Caine C, Corn B, Kanner A, Rowley H, Kundapur V, DeNittis A, Greenspoon JN, Konski AA, Bauman GS, Shah S, Shi W, Wendland M, Kachnic L, Mehta MP. Preservation of memory with conformal avoidance of the hippocampal neural stem-cell compartment during whole-brain radiotherapy for brain metastases (RTOG 0933): a phase II multi-institutional trial. J Clin Oncol. 2014 Dec 1;32(34):3810-6. doi: 10.1200/JCO.2014.57.2909. Epub 2014 Oct 27.
Other Identifiers
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CDR0000687490
Identifier Type: -
Identifier Source: secondary_id
RTOG-0933
Identifier Type: -
Identifier Source: org_study_id
NCT01366755
Identifier Type: -
Identifier Source: nct_alias