Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease
Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease
3 other identifiers
interventional
242
2 countries
232
Brief Summary
This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction 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. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.
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 Nov 2019
Longer than P75 for phase_3
232 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 2, 2019
CompletedFirst Posted
Study publicly available on registry
October 3, 2019
CompletedStudy Start
First participant enrolled
November 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
April 21, 2026
April 1, 2026
6.8 years
October 2, 2019
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical bed recurrence-free survival (SB-RFS)
Surgical bed control is defined as the absence of new nodular contrast enhancement in the surgical bed. In other words, a surgical bed recurrence-free survival (SB-RFS) event is defined as radiographic evidence of a new contrast-enhancing lesion (specifically any new progressive enhancing nodularity) at the site of the surgical resection. Will use a stratified log-rank test that compares and will report the median SB-RFS times between the single fraction stereotactic radiosurgery (SSRS) and fractionated stereotactic radiosurgery (FSRS) arms while adjusting for the stratification factors.
From the time of randomization up to 2 years post radiation
Secondary Outcomes (14)
Change in Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale score
At 9 months
Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score
At 9 months
Linear Analog Self-Assessment (LASA) overall quality of life
At 9 months
Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale score for long-term survivors
At 12 months
Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score for long-term survivors
At 12 months
- +9 more secondary outcomes
Study Arms (2)
Arm I (SSRS)
ACTIVE COMPARATORPatients undergo SSRS over 1 session.
Arm II (FSRS)
EXPERIMENTALPatients undergo FSRS over 3 or 5 daily sessions.
Interventions
Undergo SSRS
Undergo FSRS
Eligibility Criteria
You may qualify if:
- PRE-REGISTRATION:
- Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.
- Three or fewer (i.e. 0 to 3) unresected brain metastases (as defined on the post operative magnetic resonance imaging \[MRI\]) at the time of screening.
- o Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible.
- Unresected lesions must measure \< 4.0 cm in maximal extent on the contrasted post-operative treatment MRI brain scan. The unresected lesions will be treated with SRS as outlined in the treatment section of the concept.
- o Note: The metastases size restriction does not apply to the resected brain metastasis.
- One brain metastasis must be completely (gross total resection) resected =\< 30 days prior to pre-registration.
- o NOTE: May not have had resection of more than one brain metastasis.
- The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI.
- Resection cavity must measure \< 5.0 cm in maximal extent and the resection must be complete (gross total resection) on the post-operative MRI obtained =\< 30 days prior to pre-registration.
- Karnofsky performance status of \>= 60.
- For women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to pre-registration is required.
- Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
- A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to complete an MRI of the head with contrast.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (232)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Banner Thunderbird Medical Center
Glendale, Arizona, 85306, United States
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Epic Care Cyberknife Center
Walnut Creek, California, 94597, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Yale University
New Haven, Connecticut, 06520, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Morton Plant Hospital
Clearwater, Florida, 33756, 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
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607, United States
Moffitt Cancer Center
Tampa, Florida, 33612, 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
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, 83864, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Woman's Hospital
Baton Rouge, Louisiana, 70817, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114, United States
Saint Joseph Mercy Canton
Canton, Michigan, 48188, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
Ascension Providence Hospitals - Novi
Novi, Michigan, 48374, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
McLaren-Port Huron
Port Huron, Michigan, 48060, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Cambridge Medical Center
Cambridge, Minnesota, 55008, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
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 Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127, United States
Mercy Hospital Washington
Washington, Missouri, 63090, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59804, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Mount Sinai Chelsea
New York, New York, 10011, United States
Mount Sinai West
New York, New York, 10019, United States
Mount Sinai Hospital
New York, New York, 10029, 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 Oneida
Oneida, New York, 13421, 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
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, 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
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, 97814, United States
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, 97914, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, 18925, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045, United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Ascension All Saints Hospital
Racine, Wisconsin, 53405, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
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
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul D. Brown, MD
Mayo Clinic
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
October 2, 2019
First Posted
October 3, 2019
Study Start
November 19, 2019
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2028
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share