Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases
3 other identifiers
interventional
274
4 countries
270
Brief Summary
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2024
Longer than P75 for phase_3
270 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
July 8, 2024
CompletedFirst Posted
Study publicly available on registry
July 15, 2024
CompletedStudy Start
First participant enrolled
December 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2033
September 14, 2026
September 1, 2026
3.6 years
July 8, 2024
September 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to local failure
The time to local failure will be evaluated at a per-patient level. The cause-specific hazard ratio will be estimated in a Cox proportional hazards (PH) model adjusting for patients and disease characteristics. The Cox PH model will be the principle approach. The cumulative incidence function estimator will also be used to estimate the rate of local failure in the presence of competing event of deaths in the two arms separately. A complementary analysis will involve Gray's test to evaluate the difference in the distribution of local failure between treatment arms. These results will be interpreted in light of the competing deaths.
From randomization (with the treatment planning magnetic resonance imaging as the 'baseline' for purposes of disease assessment) to local tumor progression of any study lesion(s), assessed up to 5 years
Secondary Outcomes (5)
Intracranial progression-free survival (IPFS)
From the date of randomization until intracranial progression (local or distant intracranial) or death from any cause, whichever occurs first, assessed up to 5 years
Overall survival
From the date of randomization until death from any cause, assessed up to 5 years
Time to radiation necrosis (TTRN)
From randomization until radiation necrosis, assessed up to 5 years
Time to whole brain radiation therapy (WBRT)
Up to 5 years
Incidence of adverse events (AEs)
Up to 2 years from start of radiation treatment
Other Outcomes (1)
Time to local failure
Up to 5 years
Study Arms (2)
ARM I (SRS)
ACTIVE COMPARATORPatients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo CT and MRI on study.
ARM II (FSRS)
EXPERIMENTALPatients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study.
Interventions
Undergo CT
Undergo MRI
Undergo FSRS
Undergo SRS
Eligibility Criteria
You may qualify if:
- Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:
- Non-small cell lung cancer
- Melanoma
- Breast cancer
- Renal cell carcinoma
- Gastrointestinal cancer
- If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, positron emission tomography \[PET\]/CT, etc.) is required
- Patients must have at least 1 and up to 8 total intact brain metastases detected on a contrast-enhanced MRI performed ≤ 21 days prior to registration
- At least 1 of the up to 8 lesions must be a study eligible lesion, defined as lesion with a maximum diameter as measured on any orthogonal plane (axial, sagittal, coronal) of ≥ 1.0 cm and ≤ 3.0 cm
- All brain metastases must be located outside of the brainstem and ≥ 5 mm from the optic nerves or optic chiasm and ≤ 3.0 cm in maximum dimension
- Patients must have a diagnosis-specific graded prognostic assessment ≥ 1.5
- No more than 2 lesions planned for resection if clinically indicated
- No known leptomeningeal disease (LMD)
- Age ≥ 18 years
- Karnofsky performance status (KPS) ≥ 60
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
Study Sites (270)
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
City of Hope Corona
Corona, California, 92882, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UC San Diego Health System - Encinitas
Encinitas, California, 92024, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
City of Hope Antelope Valley
Lancaster, California, 93534, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Providence Queen of The Valley
Napa, California, 94558, United States
Kaiser Permanente-Ontario
Ontario, California, 91761, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, 95403, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
City of Hope South Bay
Torrance, California, 90503, United States
City of Hope Upland
Upland, California, 91786, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, 94598, 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
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, 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
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, 33166, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, 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
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
WellStar Cobb Hospital
Austell, Georgia, 30106, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701, United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, 96706, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, 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
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, 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
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Memorial Hospital East
Shiloh, Illinois, 62269, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307, United States
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307, United States
Northwest Oncology LLC
Dyer, Indiana, 46311, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342, United States
Saint Mary Medical Center
Hobart, Indiana, 46342, United States
The Community Hospital
Munster, Indiana, 46321, United States
Women's Diagnostic Center - Munster
Munster, Indiana, 46321, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
Baptist Health Hardin
Elizabethtown, Kentucky, 42701, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Norton Brownsboro Hospital and Medical Campus
Louisville, Kentucky, 40241, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303, United States
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102, United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074, United States
Maryland Proton Treatment Center
Baltimore, Maryland, 21201, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, 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
UM Capital Region Medical Center
Largo, Maryland, 20774, United States
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland, 21157, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Henry Ford Health Providence Novi Hospital
Novi, Michigan, 48374, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota, 55318, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652, United States
Valley Health System Ridgewood Campus
Ridgewood, New Jersey, 07450, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
The New York Hospital Medical Center of Queens
Flushing, New York, 11355, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
Mount Sinai Chelsea
New York, New York, 10011, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Mount Sinai West
New York, New York, 10019, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Mount Sinai South Nassau
Oceanside, New York, 11572, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
SUNY Upstate Medical Center-Community Campus
Syracuse, New York, 13215, 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
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, 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
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, 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
Kettering Medical Center
Kettering, Ohio, 45429, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania, 18104, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania, 18045, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
NRG Oncology
Philadelphia, Pennsylvania, 19103, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, United States
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania, 18951, United States
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania, 18360, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, 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
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Valley Medical Center
Renton, Washington, 98055, United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, 98684, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, 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
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, 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
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9, Canada
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Beacon Hospital
Dublin, Co Dublin, 18, Ireland
Saint Lukes Hospital
Dublin, Co Dublin, 6, Ireland
University College Hospital Galway
Galway, Co Galway, Ireland
Cork Radiation Oncology Associates Limited
Cork, Ireland
Cork University Hospital
Cork, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rupesh R Kotecha
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2024
First Posted
July 15, 2024
Study Start
December 12, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2033
Last Updated
September 14, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
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