Avoiding the Hippocampus During Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases
2 other identifiers
interventional
113
2 countries
63
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 treating patients with brain metastases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2011
Longer than P75 for phase_2
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
September 27, 2017
CompletedSeptember 27, 2017
September 1, 2017
2.2 years
October 22, 2010
August 23, 2017
September 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)
Change in Hopkins Verbal Learning Test-Revised delayed recall (HVLT\_R DR) score from baseline to 4 months after the start of treatment calculated as (baseline score - 4 month score)/ baseline score. A positive change indicates a decline in function. The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms, helping to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. Delayed recall involves recalling a list of 12 targets after a 20-minute delay. The score is the sum of the number of targets correctly recalled. Percent change calculated as 100\*\[(baseline score - 4 month score)/ baseline score\]
Baseline and 4 months from start of treatment
Secondary Outcomes (8)
Percent Change at 4 Months in Auditory Learning Measured by Cogstate's International Shopping List Test (ISLT)
Baseline and 4 months from start of treatment
Percent Change at 4 Months in Visual Learning Measured by Cogstate's One Card Learning Test (OCLT)
Baseline and 4 months from start of treatment
Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Baseline and 4 months from start of treatment
Quality of Life as Measured by the Barthel Index of Activities of Daily Living (ADL)
Baseline and 4 months from start of treatment
Overall Survival
Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.)
- +3 more secondary outcomes
Study Arms (1)
WBRT with Hippocampal Avoidance
OTHERWhole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
Interventions
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.
Eligibility Criteria
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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- NRG Oncologycollaborator
Study Sites (63)
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Arizona Center for Cancer Care - Peoria
Peoria, Arizona, 85381, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
Arizona Oncology - Tucson
Tucson, Arizona, 85704, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024, United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, 95815, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, 33176, United States
Florida Cancer Center - Palatka
Palatka, Florida, 32177, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, 46526, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, 46202, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
NSMC Cancer Center - Peabody
Danvers, Massachusetts, 01923, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Nebraska Medical Center
Omaha, Nebraska, 68198, United States
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, 07039, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, 12206, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240, United States
Southwest General Health Center
Middleburg Heights, Ohio, 44130, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104, United States
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, 97401, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Regional Cancer Center - Erie
Erie, Pennsylvania, 16505, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, 17405, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, 76022, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, 76104, United States
Memorial Hermann Hospital - Memorial City
Houston, Texas, 77024, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, 77479, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, 84157, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (1)
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.
PMID: 25349290RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Seiferheld, M.S.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Minesh P. Mehta, MD
University of Maryland Medical Systems
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2010
First Posted
October 25, 2010
Study Start
March 1, 2011
Primary Completion
May 1, 2013
Study Completion
December 1, 2016
Last Updated
September 27, 2017
Results First Posted
September 27, 2017
Record last verified: 2017-09