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
Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for Brain Metastases From Small Cell Lung Cancer
3 other identifiers
interventional
152
2 countries
231
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2021
Longer than P75 for phase_3
231 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
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 18, 2021
CompletedStudy Start
First participant enrolled
June 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
ExpectedSeptember 14, 2026
August 1, 2026
5 years
March 9, 2021
September 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to neurocognitive failure
A failure is defined using the reliable change index (RCI) criteria, as measured by the Hopkins Verbal Learning Test - Revised (HVLT-R), Controlled Oral Word Association (COWA) test, and Trail Making Test (TMT) Parts A and B. The cumulative incidence approach will be used to estimate the percentage of failures while accounting for the competing risk of death.
Up to 1 year
Secondary Outcomes (9)
Preservation of neurocognitive function
1 year
Perceived difficulties in cognition
Up to 1 year
Symptom burden
Up to 1 year
Time to intracranial disease progression
From the date of randomization to the date of intracranial disease progression, assessed up to 10 years
Overall survival
From the date of randomization to the date of death, or otherwise, the last follow-up date on which the patient was reported alive, assessed up to 10 years
- +4 more secondary outcomes
Other Outcomes (10)
Time to local brain recurrence (in brain lesions present at trial enrollment and treated with either stereotactic radiosurgery [SRS] or hippocampal-avoidant whole brain radiotherapy [HA-WBRT])
Up to 10 years
Time to incidence of distant brain relapses
Up to 10 years
Time to leptomeningeal dissemination
Up to 10 years
- +7 more other outcomes
Study Arms (2)
Arm I (SRS)
EXPERIMENTALPatients undergo SRS over 1 day (in some cases several days). Patients undergo blood sample collection and MRI throughout the study.
Arm II (HA-WBRT, memantine)
ACTIVE COMPARATORPatients 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.
Interventions
Undergo SRS
Undergo HA-WBRT
Undergo blood sample collection
Undergo MRI
Eligibility Criteria
You may qualify if:
- 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.
- +20 more criteria
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (231)
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Kaiser Permanente-Ontario
Ontario, California, 91761, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, 33544, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital-Cherokee
Canton, Georgia, 30115, United States
Northside Hospital-Forsyth
Cumming, Georgia, 30041, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
IU Health West Hospital
Avon, Indiana, 46123, United States
IU Health North Hospital
Carmel, Indiana, 46032, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
TidalHealth Richard A Henson Cancer Institute
Ocean Pines, Maryland, 21811, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, 21801, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Caro Cancer Center
Caro, Michigan, 48723, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910, United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, 48446, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, 48858, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
McLaren-Port Huron
Port Huron, Michigan, 48060, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology - Coon Rapids
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Minnesota Oncology - Edina
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology - Maple Grove
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Sands Cancer Center
Canandaigua, New York, 14424, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York, 13126, United States
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York, 14606, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Upstate Cancer Center at Hill Radiation Oncology
Syracuse, New York, 13210, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Upstate Cancer Center at Verona
Verona, New York, 13478, United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania, 18104, United States
UPMC Altoona
Altoona, Pennsylvania, 16601, United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania, 18045, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Sechler Family Cancer Center
Lebanon, Pennsylvania, 17042, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243, United States
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania, 18951, United States
Saint Luke's Hospital-Quakertown Campus
Quakertown, Pennsylvania, 18951, United States
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania, 18360, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Divine Providence Hospital
Williamsport, Pennsylvania, 17754, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
UPMC Memorial
York, Pennsylvania, 17408, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson West Houston
Houston, Texas, 77079, United States
UT MD Anderson - League City
League City, Texas, 77573, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vinai Gondi
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 18, 2021
Study Start
June 8, 2021
Primary Completion
June 24, 2026
Study Completion (Estimated)
July 1, 2031
Last Updated
September 14, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
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