Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study
Start Date
10/9/2023
Completion Date
8/12/2032
Summary
This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate and compare overall survival (OS) (measured from time of randomization) in patients with newly diagnosed oligometastatic colorectal cancer (oCRC) treated with total ablative therapy (TAT) in addition to standard of care (SOC) systemic therapy versus SOC systemic therapy. SECONDARY OBJECTIVES: I. To evaluate and compare event-free survival (EFS) (measured from time of randomization) between the two treatment arms. II. To assess the adverse events (AE) profile within each of the two treatment arms. III. To evaluate the time to local recurrence (TLR) (measured from completion of TAT) in patients with newly diagnosed oCRC treated with TAT + SOC systemic therapy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans throughout the trial. ARM 2: Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Stereotactic Ablative Radiotherapy
Resection
Microwave Ablation
Chemotherapy
Computed Tomography
Magnetic Resonance Imaging
Positron Emission Tomography
Conditions
Locations
Kingman Regional Medical Center
Kingman, Arizona 86401
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
Tower Cancer Research Foundation
Beverly Hills, California 90211
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Beebe Medical Center
Lewes, Delaware 19958
United States
Beebe South Coastal Health Campus
Millville, Delaware 19967
United States
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
United States
Beebe Health Campus
Rehoboth Beach, Delaware 19971
United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
United States
Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
United States
George Washington University Medical Center
Washington D.C., District of Columbia 20037
United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
United States
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida 33065
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
UF Health Cancer Institute - Gainesville
Gainesville, Florida 32610
United States
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida 33021
United States
Jupiter Medical Center
Jupiter, Florida 33458
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
Grady Health System
Atlanta, Georgia 30303
United States
Emory Proton Therapy Center
Atlanta, Georgia 30308
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 Luke's Cancer Institute - Boise
Boise, Idaho 83712
United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
United States
University of Illinois
Chicago, Illinois 60612
United States
Baptist Health Floyd
New Albany, Indiana 47150
United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa 52722
United States
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
United States
Greater Regional Medical Center
Creston, Iowa 50801
United States
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
Baptist Health Louisville
Louisville, Kentucky 40207
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
United States
Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
United States
Trinity Health Medical Center - Canton
Canton, Michigan 48188
United States
Chelsea Hospital
Chelsea, Michigan 48118
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
United States
Corewell Health Dearborn Hospital
Dearborn, Michigan 48124
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan 48336
United States
Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Hurley Medical Center
Flint, Michigan 48503
United States
Allegiance Health
Jackson, Michigan 49201
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
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
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan 48075
United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan 48085
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
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Regions Hospital
Saint Paul, Minnesota 55101
United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
United States
Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
United States
Parkland Health Center - Farmington
Farmington, Missouri 63640
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
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
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
United States
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
United States
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
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
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
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
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
Memorial Sloan Kettering Commack
Commack, New York 11725
United States
The New York Hospital Medical Center of Queens
Flushing, New York 11355
United States
Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York 11375
United States
Northwell Health Cancer Institute at Huntington
Greenlawn, New York 11740
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
Northern Westchester Hospital
Mount Kisco, New York 10549
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
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
Queens Cancer Center
Rego Park, New York 11374
United States
University of Rochester
Rochester, New York 14642
United States
Phelps Memorial Hospital Center
Sleepy Hollow, New York 10591
United States
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Westchester Medical Center
Valhalla, New York 10595
United States
Wilmot Cancer Institute at Webster
Webster, New York 14580
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
United States
East Carolina University
Greenville, North Carolina 27834
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
United States
Miami Valley Hospital South
Centerville, Ohio 45459
United States
MetroHealth Medical Center
Cleveland, Ohio 44109
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Miami Valley Hospital
Dayton, Ohio 45409
United States
Premier Blood and Cancer Center
Dayton, Ohio 45409
United States
Dayton Physician LLC - Englewood
Dayton, Ohio 45415
United States
Miami Valley Hospital North
Dayton, Ohio 45415
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
United States
Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
United States
Upper Valley Medical Center
Troy, Ohio 45373
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
United States
Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United States
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania 17601
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
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
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia 23116
United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia 23226
United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia 23230
United States
Valley Medical Center
Renton, Washington 98055
United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia 25701
United States
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin 54409
United States
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
Appleton, Wisconsin 54915
United States
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
Brookfield, Wisconsin 53045
United States
Ascension Calumet Hospital-Chilton
Chilton, Wisconsin 53014
United States
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin 53132
United States
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
Mequon, Wisconsin 53097
United States
Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee
Milwaukee, Wisconsin 53210
United States
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
Milwaukee, Wisconsin 53211
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
Oshkosh, Wisconsin 54904
United States
Ascension All Saints Hospital-Spring Street-Racine
Racine, Wisconsin 53405
United States
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
Rhinelander, Wisconsin 54501
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
United States
Aspirus Cancer Care-Wausau
Wausau, Wisconsin 54401
United States
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
Wauwatosa, Wisconsin 53226
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