Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study
NCT ID: NCT05673148
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
364 participants
INTERVENTIONAL
2023-10-09
2032-08-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 (TAT, SOC chemotherapy
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 CT or MRI or PET/CT scans throughout the trial.
Stereotactic Ablative Radiotherapy
Undergo SABR
Resection
undergo surgical resection
Microwave Ablation
undergo microwave ablation
Chemotherapy
Receive SOC chemotherapy
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET scan
Arm 2 (SOC chemotherapy)
Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.
Chemotherapy
Receive SOC chemotherapy
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET scan
Interventions
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Stereotactic Ablative Radiotherapy
Undergo SABR
Resection
undergo surgical resection
Microwave Ablation
undergo microwave ablation
Chemotherapy
Receive SOC chemotherapy
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor
* PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation
* PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants
* PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible
* PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy.
* Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.
* Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study.
* Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and/or stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the patient must be seen by a radiation oncologist in consultation to verify eligibility.
* Single sites include:
* Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field
* PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration
* REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration
* REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined
* REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1
* REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months)
* REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease
* REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects.
\* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
* REGISTRATION (STEP 1): Age \>= 18 years
* REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* REGISTRATION (STEP 1): Platelet count \>= 50,000/mm\^3
* REGISTRATION (STEP 1): Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 30 mL/min
\* Calculated using the Cockcroft-Gault equation
* REGISTRATION (STEP 1): Total bilirubin =\< 1.5 x ULN
* REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x ULN
\* In the event of metastatic liver disease, =\< 5 x ULN
* REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility
* REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Locations
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Kingman Regional Medical Center
Kingman, Arizona, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Beebe Medical Center
Lewes, Delaware, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Emory Proton Therapy Center
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
University of Illinois
Chicago, Illinois, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States
Greater Regional Medical Center
Creston, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Baptist Health Louisville
Louisville, Kentucky, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, Michigan, United States
Chelsea Hospital
Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Henry Ford Health Providence Novi Hospital
Novi, Michigan, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, United States
Parkland Health Center - Farmington
Farmington, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Renown Regional Medical Center
Reno, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
The New York Hospital Medical Center of Queens
Flushing, New York, United States
Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York, United States
Northwell Health Cancer Institute at Huntington
Greenlawn, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
Mount Sinai West
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Manhattan Eye Ear and Throat Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Queens Cancer Center
Rego Park, New York, United States
University of Rochester
Rochester, New York, United States
Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Wilmot Cancer Institute at Webster
Webster, New York, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Premier Blood and Cancer Center
Dayton, Ohio, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, United States
Valley Medical Center
Renton, Washington, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, United States
Ascension Calumet Hospital
Chilton, Wisconsin, United States
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, United States
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee, Wisconsin, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Ascension Mercy Hospital
Oshkosh, Wisconsin, United States
Ascension All Saints Hospital
Racine, Wisconsin, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Hitchcock KE, Miller ED, Shi Q, Dixon JG, Gholami S, White SB, Wu C, Goulet CC, George M, Jee KW, Wright CL, Yaeger R, Shergill A, Hong TS, George TJ, O'Reilly EM, Meyerhardt JA, Romesser PB. Alliance for clinical trials in Oncology (Alliance) trial A022101/NRG-GI009: a pragmatic randomized phase III trial evaluating total ablative therapy for patients with limited metastatic colorectal cancer: evaluating radiation, ablation, and surgery (ERASur). BMC Cancer. 2024 Feb 13;24(1):201. doi: 10.1186/s12885-024-11899-2.
Miller ED, Hitchcock KE, Romesser PB. Oligometastatic Colorectal Cancer: A Review of Definitions and Patient Selection for Local Therapies. J Gastrointest Cancer. 2023 Dec;54(4):1116-1127. doi: 10.1007/s12029-022-00900-5. Epub 2023 Jan 18.
Other Identifiers
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NCI-2022-09253
Identifier Type: OTHER
Identifier Source: secondary_id
A022101
Identifier Type: -
Identifier Source: org_study_id
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