Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability
Purpose
This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.
Conditions
- Metastatic Lung Small Cell Carcinoma
- Metastatic Malignant Neoplasm in the Brain
- Recurrent Lung Small Cell Carcinoma
- Stage IV Lung Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis); - Patients with de novo or recurrent small cell lung cancer are permitted. - Brain metastases =< 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =< 21 days prior to study entry. - The total tumor volume must be 30 cm^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g. xyz/2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumor volume. - Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer. - Brain metastases must be diagnosed on MRI, which will include the following elements: - REQUIRED MRI ELEMENTS - Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm. - Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged). - A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane. - ADDITIONAL RECOMMENDATIONS - Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence. - Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1. - Recommendation is that imaging be performed on a 3 Tesla (3T) MRI. - Recommendation is that the study participants be scanned on the same MRI instrument at each time point. - Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020. - If additional sequences are obtained, total imaging time should not exceed 60 minutes. - If additional metastases not known at the time of registration/randomization or seen in the MRI used for eligibility are subsequently found on the radiation therapy (RT) planning MRI such that the total intacranial volume exceeds 30 cm^3, the patient is still considered eligible. - History/physical examination - Age >= 18 - Karnofsky performance status of >= 70 - Creatinine clearance >= 30 ml/min - Following the diagnosis of brain metastases, patients can initiate and treat with systemic (chemotherapy and/or immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g., brainstem, pre-/post-central gyrus, visual cortex). However, within 21 days prior to enrollment, brain MRI must be repeated to confirm eligibility. - Patients with symptomatic brain metastases and/or brain metastases in eloquent locations (e.g., brainstem, pre-/post central gyrus, visual cortex) are eligible for enrollment on the trial; however, the specific treatment approach of starting with systemic therapy alone and delaying brain radiation is not recommended for these patients. - Concurrent immunotherapy with brain radiation (SRS or HA-WBRT) is permitted. - Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to registration. Women of childbearing potential and men who are sexually active must use contraception while on study. - Patients may have had prior intracranial surgical resection. - Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian. - The patient must provide study-specific informed consent prior to study entry. - Patients with impaired decision-making capacity are not permitted on study. - ELIGIBILITY CRITERIA PRIOR TO STEP 2 REGISTRATION - The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive test will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2. - NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration. - PRIOR TO STEP 2 REGISTRATION: The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2. NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.
Exclusion Criteria
- Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent immunotherapy is permitted. - For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS treatments. - Brainstem metastasis > 10 cm^3 - Prior allergic reaction to memantine. - Patients with definitive leptomeningeal metastases. - Known history of demyelinating disease such as multiple sclerosis. - Contraindication to MR imaging such as implanted metal devices that are MRI-incompatible, allergy to MRI contrast that cannot be adequately addressed with pre-contrast medications, or foreign bodies that preclude MRI imaging. (Questions regarding MRI compatibility of implanted objects should be reviewed with the Radiology Department performing the MRI). - Current use of (other N-methyl-D-aspartate [NMDA] antagonists) amantadine, ketamine, or dextromethorphan. - Radiographic evidence of hydrocephalus or other architectural change of the ventricular system resulting in significant anatomic distortion of the hippocampus, including placement of external ventricular drain or ventriculoperitoneal shunt. - Mild cases of hydrocephalus not resulting in significant anatomic distortion of the hippocampus are permitted. - Prior radiotherapy to the brain, including SRS, WBRT, or prophylactic cranial irradiation (PCI).
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm I (SRS) |
Patients undergo SRS over 1 day (in some cases several days). Patients undergo blood sample collection and MRI throughout the study. |
|
|
Active Comparator Arm II (HA-WBRT, memantine) |
Patients also undergo HA-WBRT QD for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients will also receive memantine PO QD or BID for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and MRI throughout the study. |
|
Recruiting Locations
Kaiser Permanente-Anaheim
Anaheim, California 92806
Anaheim, California 92806
Kaiser Permanente-Bellflower
Bellflower, California 90706
Bellflower, California 90706
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Los Angeles General Medical Center
Los Angeles, California 90033
Los Angeles, California 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451
Site Public Contact
323-865-0451
Kaiser Permanente-Ontario
Ontario, California 91761
Ontario, California 91761
Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
Tampa, Florida 33607
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
Tampa, Florida 33612
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida 33544
Wesley Chapel, Florida 33544
Northside Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Northside Hospital-Cherokee
Canton, Georgia 30115
Canton, Georgia 30115
Northside Hospital-Forsyth
Cumming, Georgia 30041
Cumming, Georgia 30041
Rush-Copley Medical Center
Aurora, Illinois 60504
Aurora, Illinois 60504
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
New Lenox, Illinois 60451
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
OSF Saint Francis Medical Center
Peoria, Illinois 61637
Peoria, Illinois 61637
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
The Carle Foundation Hospital
Urbana, Illinois 61801
Urbana, Illinois 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
IU Health West Hospital
Avon, Indiana 46123
Avon, Indiana 46123
IU Health North Hospital
Carmel, Indiana 46032
Carmel, Indiana 46032
Goshen Center for Cancer Care
Goshen, Indiana 46526
Goshen, Indiana 46526
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
IU Health Methodist Hospital
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Mary Greeley Medical Center
Ames, Iowa 50010
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames, Iowa 50010
Ames, Iowa 50010
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429
Site Public Contact
502-562-3429
UofL Health Medical Center Northeast
Louisville, Kentucky 40245
Louisville, Kentucky 40245
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823
Site Public Contact
800-888-8823
UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
Bel Air, Maryland 21014
Contact:
Site Public Contact
443-643-3010
Site Public Contact
443-643-3010
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300
Site Public Contact
443-546-1300
University of Maryland Shore Medical Center at Easton
Easton, Maryland 21601
Easton, Maryland 21601
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100
Site Public Contact
410-553-8100
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265
Site Public Contact
617-638-8265
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
Bay City, Michigan 48706
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health Medical Center - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
McLaren Cancer Institute-Flint
Flint, Michigan 48532
Flint, Michigan 48532
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan 48910
Lansing, Michigan 48910
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan 48446
Lapeer, Michigan 48446
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan 48043
Mount Clemens, Michigan 48043
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan 48858
Mount Pleasant, Michigan 48858
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan 49770
Petoskey, Michigan 49770
McLaren-Port Huron
Port Huron, Michigan 48060
Port Huron, Michigan 48060
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Monticello Cancer Center
Monticello, Minnesota 55362
Monticello, Minnesota 55362
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Lakeview Hospital
Stillwater, Minnesota 55082
Stillwater, Minnesota 55082
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Woodbury, Minnesota 55125
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Freeman Health System
Joplin, Missouri 64804
Joplin, Missouri 64804
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Missouri Baptist Medical Center
St Louis, Missouri 63131
St Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Cooper Hospital University Medical Center
Camden, New Jersey 08103
Camden, New Jersey 08103
Contact:
Site Public Contact
856-325-6757
Site Public Contact
856-325-6757
Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York 13126
Oswego, New York 13126
State University of New York Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476
Site Public Contact
315-464-5476
Upstate Cancer Center at Hill Radiation Oncology
Syracuse, New York 13210
Syracuse, New York 13210
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011
Avon, Ohio 44011
Contact:
Site Public Contact
800-641-2422
Site Public Contact
800-641-2422
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Case Western Reserve University
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
Mentor, Ohio 44060
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio 43551
Perrysburg, Ohio 43551
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
West Chester, Ohio 45069
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
UPMC Altoona
Altoona, Pennsylvania 16601
Altoona, Pennsylvania 16601
Carlisle Regional Cancer Center
Carlisle, Pennsylvania 17015
Carlisle, Pennsylvania 17015
Chambersburg Hospital
Chambersburg, Pennsylvania 17201
Chambersburg, Pennsylvania 17201
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840
Site Public Contact
717-721-4840
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Farrell, Pennsylvania 16121
Adams Cancer Center
Gettysburg, Pennsylvania 17325
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
Greensburg, Pennsylvania 15601
Contact:
Site Public Contact
724-838-1900
Site Public Contact
724-838-1900
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Harrisburg, Pennsylvania 17109
Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Lebanon, Pennsylvania 17042
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Contact:
Site Public Contact
412-647-2811
Site Public Contact
412-647-2811
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Contact:
Site Public Contact
412-647-2811
Site Public Contact
412-647-2811
UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
Pittsburgh, Pennsylvania 15215
Contact:
Site Public Contact
412-784-4900
Site Public Contact
412-784-4900
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-621-2334
Site Public Contact
412-621-2334
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Pittsburgh, Pennsylvania 15237
Contact:
Site Public Contact
412-367-6454
Site Public Contact
412-367-6454
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
Pittsburgh, Pennsylvania 15243
Contact:
Site Public Contact
412-502-3920
Site Public Contact
412-502-3920
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Divine Providence Hospital
Williamsport, Pennsylvania 17754
Williamsport, Pennsylvania 17754
WellSpan Health-York Cancer Center
York, Pennsylvania 17403
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
WellSpan Health-York Hospital
York, Pennsylvania 17403
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957
Site Public Contact
877-441-7957
UPMC Memorial
York, Pennsylvania 17408
York, Pennsylvania 17408
Contact:
Site Public Contact
717-724-6760
Site Public Contact
717-724-6760
McLeod Regional Medical Center
Florence, South Carolina 29506
Florence, South Carolina 29506
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
MD Anderson in The Woodlands
Conroe, Texas 77384
Conroe, Texas 77384
M D Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
MD Anderson West Houston
Houston, Texas 77079
Houston, Texas 77079
MD Anderson League City
League City, Texas 77573
League City, Texas 77573
MD Anderson in Sugar Land
Sugar Land, Texas 77478
Sugar Land, Texas 77478
Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Antigo, Wisconsin 54409
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Appleton, Wisconsin 54911
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
Madison, Wisconsin 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100
Site Public Contact
262-257-5100
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666
Site Public Contact
414-805-3666
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
Drexel Town Square Health Center
Oak Creek, Wisconsin 53154
Oak Creek, Wisconsin 53154
Contact:
Site Public Contact
414-805-0505
Site Public Contact
414-805-0505
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin 54501
Rhinelander, Wisconsin 54501
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54481
Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866
Site Public Contact
877-405-6866
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
West Bend, Wisconsin 53095
Contact:
Site Public Contact
414-805-0505
Site Public Contact
414-805-0505
More Details
- Status
- Recruiting
- Sponsor
- NRG Oncology
Study Contact
Detailed Description
PRIMARY OBJECTIVE: I. Determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine hydrochloride (memantine) for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test - Revised (HVLT-R), Controlled Oral Word Association (COWA) test, and the Trail Making Test (TMT). SECONDARY OBJECTIVES: I. Determine whether SRS relative to HA-WBRT plus memantine for brain metastases from SCLC preserves cognitive function as separately measured by the HVLT-R, COWA, TMT Parts A and B, and Clinical Trial Battery Composite (CTB COMP). II. Assess perceived difficulties in cognitive abilities using Patient Reported Outcomes Measurement Information System (PROMIS) after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. III. Assess symptom burden using the MD Anderson Symptom Inventory for brain tumor (MDASI-BT) after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. IV. Compare cumulative incidence of intracranial disease progression after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. V. Compare overall survival after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. VI. Compare cumulative incidence of neurologic death after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. VII. Compare the number of salvage procedures used to manage recurrent intracranial disease following SRS relative to HA-WBRT plus memantine for SCLC brain metastases. VIII. Compare adverse events between the treatment arms according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. IX. Compare the risk of developing cerebral necrosis between SRS and HA-WBRT plus memantine in patients receiving concurrent immunotherapy. EXPLORATORY OBJECTIVES: I. Compare cumulative incidence of local brain recurrence, distant brain relapse, and leptomeningeal dissemination after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. II. Compare the cost of brain-related therapies and quality-adjusted life years in patients who receive SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. III. Evaluate the time delay to salvage WBRT or HA-WBRT in patients enrolled on the SRS arm. IV. Evaluate whether a time delay for chemotherapy has an effect on overall survival in patients receiving HA WBRT plus memantine relative to SRS for brain metastases from SCLC. V. Evaluate baseline magnetic resonance (MR) imaging biomarkers of white matter injury and hippocampal volumetry as potential predictors of cognitive decline and differential benefit from SRS relative to HA-WBRT plus memantine for brain metastases from SCLC. VI. Evaluate the correlation between neurocognitive functioning and patient-reported outcomes. VII. Collect serum, plasma and imaging studies for future translational research analyses. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo SRS over 1 day (in some cases several days). ARM II: Patients undergo HA-WBRT once daily (QD) for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive memantine orally (PO) QD or twice daily (BID) for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and magnetic resonance imaging (MRI) throughout the study. After completion of study treatment, patients are followed up every 2-3 months for 1 year, and then every 6 months thereafter.