Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
TAILOR RT
TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
2 other identifiers
interventional
2,140
2 countries
483
Brief Summary
The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Oct 2018
Typical duration for phase_3 breast-cancer
483 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 28, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2018
CompletedStudy Start
First participant enrolled
October 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
April 14, 2026
April 1, 2026
8.9 years
March 28, 2018
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not
Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.
9.5 years
Secondary Outcomes (12)
Compare the invasive disease-free survival between patients that received regional RT or not.
9.5 years
Compare the breast cancer mortality between patients that received regional RT or not.
9.5 years
Compare the overall survival (OS) between patients that received regional RT or not
9.5 years
Compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not.
9.5 years
Compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not.
9.5 years
- +7 more secondary outcomes
Study Arms (2)
No Regional Radiotherapy
ACTIVE COMPARATORA. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy
Regional Radiotherapy
ACTIVE COMPARATORA. WBI plus RT to the regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following BCS or; B. RT to the chestwall and regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following mastectomy
Interventions
Eligibility Criteria
You may qualify if:
- Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care.
- Patients must have been treated by BCS or mastectomy with clear margins of excision. Post-mastectomy positive margins for invasive disease and/or DCIS is not allowed. Multifocal disease (i.e. the presence of two or more foci or breast cancer within the same breast quadrant) and multicentric disease (i.e. the presence of two or more foci of breast cancer in different quadrants of the same breast) are allowed.
- Patients with T3N0 disease are eligible.
- Patients with disease limited to nodal micrometastases are eligible
- Patients with nodal macrometastases (\>2mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, \> 2 mm).
- Patients treated by mastectomy and SLNB alone must have only 1-2 positive axillary nodes (macrometastases, \> 2 mm).
- Patients must be ER ≥ 1% and HER2 negative on local testing
- Patients must have an Oncotype DX recurrence score ≤25 obtained from testing of breast tumour tissue from a core biopsy or from the surgical specimen.
- Patient must consent to provision of, and investigator(s) must agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays described in the protocol may be conducted
- Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted.
- Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered. For all patients, endocrine therapy can be given concurrently or following RT.
- Patients may or may not have had adjuvant chemotherapy.
- RT must commence within 16 weeks of definitive surgery if the patient is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 12 weeks after the last dose. (Note: adjuvant chemotherapy may be ongoing at the time of randomization). Definitive surgery is defined as the last breast cancer-related surgery.
- Patient's ECOG performance status must be 0, 1 or 2.
- Patient's age must be ≥ 35 years.
- +5 more criteria
You may not qualify if:
- Patients with nodal disease limited to isolated tumour cells (pN0i+ \< 0.2 mm).
- Patients with pT3N1 and pT4 disease (Note: patients with T3N0 are eligible).
- Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
- Synchronous or previous contralateral invasive breast cancer. (Patients with contralateral DCIS are eligible unless previously treated with radiation.)
- History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years.
- Patients who are pregnant.
- Patients that have had prior ipsilateral chestwall/thoracic radiation.
- Patients treated with chemo or endocrine therapy administered in the neoadjuvant setting for breast cancer. Endocrine therapy exposure 12 weeks or less prior to surgery is permitted.
- Patients with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.) which would preclude RT.
- Patients with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alliance for Clinical Trials in Oncologycollaborator
- Eastern Cooperative Oncology Groupcollaborator
- NRG Oncologycollaborator
- SWOG Cancer Research Networkcollaborator
- Canadian Cancer Trials Grouplead
Study Sites (483)
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, 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
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
City of Hope Corona
Corona, California, 92882, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
UC San Diego Health System - Encinitas
Encinitas, California, 92024, United States
Fresno Cancer Center
Fresno, California, 93720, 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
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Providence Queen of The Valley
Napa, California, 94558, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Kaiser Permanente-Ontario
Ontario, California, 91761, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Desert Regional Medical Center
Palm Springs, California, 92262, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Saint John's Cancer Institute
Santa Monica, California, 90404, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Saint Helena Hospital
St. Helena, California, 94574, United States
City of Hope South Bay
Torrance, California, 90503, United States
City of Hope Upland
Upland, California, 91786, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
BASS Medical Group - Lennon
Walnut Creek, California, 94598, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923, United States
UCHealth - Cherry Creek
Denver, Colorado, 80206, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, 80401, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539, United States
Saint Anthony North Hospital
Westminster, Colorado, 80023, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437, United States
Smilow Cancer Hospital-Hamden Care Center
Hamden, Connecticut, 06518, United States
Yale University
New Haven, Connecticut, 06520, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, 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
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, 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
Miami Cancer Institute
Miami, Florida, 33176, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
Miami Cancer Institute at Plantation
Plantation, Florida, 33324, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Saint Anthony's Hospital Cancer Care Center
St. Petersburg, Florida, 33705, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Cleveland Clinic-Weston
Weston, Florida, 33331, United States
Grady Health System
Atlanta, Georgia, 30303, 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
Emory Decatur Hospital
Decatur, Georgia, 30033, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
Swedish Covenant Hospital
Chicago, Illinois, 60625, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114, 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
IU Health West Hospital
Avon, Indiana, 46123, United States
IU Health North Hospital
Carmel, Indiana, 46032, United States
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307, United States
IU Health Central Indiana Cancer Centers-Fishers
Fishers, Indiana, 46037, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Community Cancer Center East
Indianapolis, Indiana, 46219, United States
Community Cancer Center South
Indianapolis, Indiana, 46227, United States
Community Cancer Center North
Indianapolis, Indiana, 46256, United States
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
Greater Regional Medical Center
Creston, Iowa, 50801, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, 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
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017, United States
Saint Elizabeth Healthcare Fort Thomas
Fort Thomas, Kentucky, 41075, United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, 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
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, 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
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Suburban Hospital
Bethesda, Maryland, 20814, 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 Saint Joseph Medical Center
Towson, Maryland, 21204, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706, United States
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, 48346, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336, United States
McLaren Cancer Institute-Flint
Flint, Michigan, 48532, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, 48858, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
Henry Ford Health Providence Novi Hospital
Novi, Michigan, 48374, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770, United States
McLaren-Port Huron
Port Huron, Michigan, 48060, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Hi-Line Sletten Cancer Center
Havre, Montana, 59501, United States
Community Medical Center
Missoula, Montana, 59804, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820, United States
Exeter Hospital
Exeter, New Hampshire, 03833, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
CentraState Medical Center
Freehold, New Jersey, 07728, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, 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
Lovelace Radiation Oncology
Albuquerque, New Mexico, 87109, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
Memorial Medical Center-Las Cruces
Las Cruces, New Mexico, 88011, United States
Mount Sinai Queens
Astoria, New York, 11102, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220, United States
Sands Cancer Center
Canandaigua, New York, 14424, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, 14437, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
Mount Sinai Union Square
New York, New York, 10003, 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
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Nyack Hospital
Nyack, New York, 10960, United States
Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York, 14606, United States
Highland Hospital
Rochester, New York, 14620, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Pluta Cancer Center
Rochester, New York, 14623, 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
Montefiore Medical Center-Einstein Campus
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
Mount Sinai South Nassau
Valley Stream, New York, 11580, United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, 28816, United States
Duke Cancer Center Cary
Cary, North Carolina, 27518, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Geauga Hospital
Chardon, Ohio, 44024, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, 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
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Dublin Methodist Hospital
Dublin, Ohio, 43016, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130, United States
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, 44266, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
University Hospitals Sharon Health Center
Wadsworth, Ohio, 44281, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, 44145, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Good Samaritan Hospital
Corvallis, Oregon, 97330, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, 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
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
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
IRMC Cancer Center
Indiana, Pennsylvania, 15701, United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901, United States
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050, United States
Riddle Memorial Hospital
Media, Pennsylvania, 19063, United States
Forbes Hospital
Monroeville, Pennsylvania, 15146, United States
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146, United States
Bryn Mawr Health Center
Newtown Square, Pennsylvania, 19073, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, 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-Saint Margaret
Pittsburgh, Pennsylvania, 15215, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, 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
Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania, 19605, United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, 15301, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, 17403, United States
UPMC Memorial
York, Pennsylvania, 17408, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Kent Hospital
Warwick, Rhode Island, 02886, United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina, 29926, United States
Beaufort Memorial/New River Cancer Center
Okatie, South Carolina, 29909, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, 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
Houston Methodist San Jacinto Hospital
Baytown, Texas, 77521, United States
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
Houston Methodist Cypress Hospital
Cypress, Texas, 77429, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Methodist Willowbrook Hospital
Houston, Texas, 77070, United States
MD Anderson West Houston
Houston, Texas, 77079, United States
Houston Methodist West Hospital
Houston, Texas, 77094, United States
Doctor's Hospital of Laredo
Laredo, Texas, 78041, United States
MD Anderson League City
League City, Texas, 77573, United States
Houston Methodist Saint John Hospital
Nassau Bay, Texas, 77058, 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
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, 77479, United States
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, 77385, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Farmington Health Center
Farmington, Utah, 84025, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Riverton Hospital
Riverton, Utah, 84065, United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
South Jordan Health Center
South Jordan, Utah, 84009, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230, United States
CJW Medical Center - Johnston-Willis Campus
Richmond, Virginia, 23235, United States
MultiCare Auburn Medical Center
Auburn, Washington, 98001, United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, 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
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BCCA-Abbotsford Cancer Centre
Abbotsford British Columbia, British Columbia, V2S 1K2, Canada
BCCA-Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
BCCA-Cancer Centre for the North
Prince George, British Columbia, V2M 7E9, Canada
BCCA-Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
BCCA-Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
QEII Health Sciences Centre/Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Waterloo Regional Health Network
Kitchener, Ontario, N2G 1G3, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6, Canada
Niagara Health System-Saint Catharines General
Saint Catharines, Ontario, L2S 0A9, Canada
Algoma District Cancer Program Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CSSS Champlain-Charles Le Moyne
Greenfield Park, Quebec, J4V 2H1, Canada
Hopital de la Cite-de-la-Sante
Laval, Quebec, H7M 3L9, Canada
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, 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
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4, 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
- STUDY CHAIR
Timothy Whelan
Juravinski Cancer Centre at Hamilton Health Sciences, Ontario Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2018
First Posted
April 5, 2018
Study Start
October 16, 2018
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share