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Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study

Program Status

Recruiting

Phase

Phase 3

Prior Immunotherapy Allowed

CRC-directed Trial

Yes

Drugs

Chemotherapy

Tags

MSS/ MMRp

Comments

Trial for patients with colorectal cancer that has spread to up to 4 body sites (newly diagnosed oligometastatic colorectal cancer, limited metastatic).
Patients are randomized to receive the standard of care (SOC) (systemic therapy alone, chemotherapy regimens) OR such standard of care with the addition of TAT (total ablative therapy) for the metastatic lesions. That is, along with receiving chemotherapy, the mets will be ablated (eliminated) with intensive radiotherapy, called stereotactic ablative radiotherapy (SABR), with or without surgical resection and/or microwave ablation (MWA).

Key inclusion criteria: Primary tumor is already resected OR primary tumor is surgically amenable to resection; 4 or less metastatic sites; liver-only disease is not admitted (For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible).
See other inclusion and exclusion criteria.

Helpful Links

Alliance 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).

Location	Location Status
United States
Kingman Regional Medical Center Kingman, Arizona 86401	Recruiting
Mayo Clinic Hospital in Arizona Phoenix, Arizona 85054	Recruiting
Tower Cancer Research Foundation Beverly Hills, California 90211	Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California 92612	Recruiting
Cedars Sinai Medical Center Los Angeles, California 90048	Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California 92868	Recruiting
University of California Davis Comprehensive Cancer Center Sacramento, California 95817	Active, not recruiting
Beebe Medical Center Lewes, Delaware 19958	Recruiting
Beebe South Coastal Health Campus Millville, Delaware 19967	Recruiting
Helen F Graham Cancer Center Newark, Delaware 19713	Recruiting
Medical Oncology Hematology Consultants PA Newark, Delaware 19713	Recruiting
Christiana Care Health System-Christiana Hospital Newark, Delaware 19718	Recruiting
Beebe Health Campus Rehoboth Beach, Delaware 19971	Recruiting
Christiana Care Health System-Wilmington Hospital Wilmington, Delaware 19801	Recruiting
Sibley Memorial Hospital Washington, District of Columbia 20016	Suspended
George Washington University Medical Center Washington, District of Columbia 20037	Recruiting
University of Florida Health Science Center - Gainesville Gainesville, Florida 32610	Recruiting
Jupiter Medical Center Jupiter, Florida 33458	Recruiting
Miami Cancer Institute Miami, Florida 33176	Recruiting
Grady Health System Atlanta, Georgia 30303	Recruiting
Emory Proton Therapy Center Atlanta, Georgia 30308	Recruiting
Emory University Hospital Midtown Atlanta, Georgia 30308	Recruiting
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia 30322	Recruiting
Emory Saint Joseph's Hospital Atlanta, Georgia 30342	Recruiting
Saint Luke's Cancer Institute - Boise Boise, Idaho 83712	Recruiting
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho 83619	Recruiting
Saint Luke's Cancer Institute - Meridian Meridian, Idaho 83642	Recruiting
Saint Luke's Cancer Institute - Nampa Nampa, Idaho 83687	Recruiting
Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho 83301	Recruiting
University of Illinois Chicago, Illinois 60612	Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa 50023	Recruiting
Mercy Cancer Center-West Lakes Clive, Iowa 50325	Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa 50325	Recruiting
Greater Regional Medical Center Creston, Iowa 50801	Recruiting
Iowa Methodist Medical Center Des Moines, Iowa 50309	Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa 50309	Recruiting
Mercy Medical Center - Des Moines Des Moines, Iowa 50314	Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa 50314	Recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa 50263	Recruiting
Mercy Medical Center-West Lakes West Des Moines, Iowa 50266	Recruiting
University of Kentucky/Markey Cancer Center Lexington, Kentucky 40536	Active, not recruiting
University Medical Center New Orleans New Orleans, Louisiana 70112	Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland 21287	Recruiting
Boston Medical Center Boston, Massachusetts 02118	Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan 48106	Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan 48114	Recruiting
Trinity Health Medical Center - Brighton Brighton, Michigan 48114	Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan 48188	Recruiting
Trinity Health Medical Center - Canton Canton, Michigan 48188	Recruiting
Chelsea Hospital Chelsea, Michigan 48118	Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan 48118	Recruiting
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan 48038	Recruiting
Corewell Health Dearborn Hospital Dearborn, Michigan 48124	Recruiting
Henry Ford Hospital Detroit, Michigan 48202	Recruiting
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan 48336	Recruiting
Genesys Hurley Cancer Institute Flint, Michigan 48503	Recruiting
Hurley Medical Center Flint, Michigan 48503	Recruiting
Allegiance Health Jackson, Michigan 49201	Recruiting
University of Michigan Health - Sparrow Lansing Lansing, Michigan 48912	Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan 48154	Recruiting
Henry Ford Health Providence Novi Hospital Novi, Michigan 48374	Recruiting
Corewell Health William Beaumont University Hospital Royal Oak, Michigan 48073	Recruiting
Henry Ford Health Providence Southfield Hospital Southfield, Michigan 48075	Recruiting
Corewell Health Beaumont Troy Hospital Troy, Michigan 48085	Recruiting
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan 48322	Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan 48197	Recruiting
Sanford Joe Lueken Cancer Center Bemidji, Minnesota 56601	Recruiting
Regions Hospital Saint Paul, Minnesota 55101	Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi 39705	Recruiting
Baptist Cancer Center-Grenada Grenada, Mississippi 38901	Recruiting
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi 38652	Recruiting
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi 38655	Recruiting
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi 38671	Recruiting
Parkland Health Center - Farmington Farmington, Missouri 63640	Recruiting
Mercy Hospital South Saint Louis, Missouri 63128	Recruiting
Missouri Baptist Medical Center Saint Louis, Missouri 63131	Recruiting
Mercy Hospital Saint Louis Saint Louis, Missouri 63141	Recruiting
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri 63670	Recruiting
Mercy Hospital Springfield Springfield, Missouri 65804	Recruiting
Missouri Baptist Sullivan Hospital Sullivan, Missouri 63080	Recruiting
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri 63127	Recruiting
Billings Clinic Cancer Center Billings, Montana 59101	Recruiting
Benefis Sletten Cancer Institute Great Falls, Montana 59405	Recruiting
Nebraska Medicine-Bellevue Bellevue, Nebraska 68123	Recruiting
Nebraska Medicine-Village Pointe Omaha, Nebraska 68118	Recruiting
University of Nebraska Medical Center Omaha, Nebraska 68198	Recruiting
Renown Regional Medical Center Reno, Nevada 89502	Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire 03756	Recruiting
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey 07920	Recruiting
Memorial Sloan Kettering Monmouth Middletown, New Jersey 07748	Recruiting
Memorial Sloan Kettering Bergen Montvale, New Jersey 07645	Recruiting
University of New Mexico Cancer Center Albuquerque, New Mexico 87106	Recruiting
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn, New York 11215	Recruiting
Memorial Sloan Kettering Commack Commack, New York 11725	Recruiting
The New York Hospital Medical Center of Queens Flushing, New York 11355	Recruiting
Northwell Health Physicians Partners Radiation Medicine at Queens Forest Hills, New York 11375	Recruiting
Northwell Health Cancer Institute at Huntington Greenlawn, New York 11740	Recruiting
Memorial Sloan Kettering Westchester Harrison, New York 10604	Recruiting
Northwell Health/Center for Advanced Medicine Lake Success, New York 11042	Recruiting
Northern Westchester Hospital Mount Kisco, New York 10549	Recruiting
Mount Sinai West New York, New York 10019	Recruiting
Mount Sinai Hospital New York, New York 10029	Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York 10032	Active, not recruiting
Manhattan Eye Ear and Throat Hospital New York, New York 10065	Recruiting
Memorial Sloan Kettering Cancer Center New York, New York 10065	Recruiting
NYP/Weill Cornell Medical Center New York, New York 10065	Recruiting
Lenox Hill Hospital New York, New York 10075	Recruiting
Queens Cancer Center Rego Park, New York 11374	Recruiting
University of Rochester Rochester, New York 14642	Active, not recruiting
Memorial Sloan Kettering Nassau Uniondale, New York 11553	Recruiting
Westchester Medical Center Valhalla, New York 10595	Recruiting
Wilmot Cancer Institute at Webster Webster, New York 14580	Active, not recruiting
Sanford Bismarck Medical Center Bismarck, North Dakota 58501	Recruiting
Sanford Broadway Medical Center Fargo, North Dakota 58122	Recruiting
Sanford Roger Maris Cancer Center Fargo, North Dakota 58122	Recruiting
Dayton Physicians LLC-Miami Valley South Centerville, Ohio 45459	Recruiting
Miami Valley Hospital South Centerville, Ohio 45459	Recruiting
MetroHealth Medical Center Cleveland, Ohio 44109	Active, not recruiting
Ohio State University Comprehensive Cancer Center Columbus, Ohio 43210	Recruiting
Miami Valley Hospital Dayton, Ohio 45409	Recruiting
Premier Blood and Cancer Center Dayton, Ohio 45409	Recruiting
Dayton Physician LLC - Englewood Dayton, Ohio 45415	Recruiting
Miami Valley Hospital North Dayton, Ohio 45415	Recruiting
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio 45005-1066	Recruiting
Dayton Physicians LLC-Atrium Franklin, Ohio 45005	Recruiting
Miami Valley Cancer Care and Infusion Greenville, Ohio 45331	Recruiting
Upper Valley Medical Center Troy, Ohio 45373	Recruiting
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma 73104	Recruiting
Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania 19317	Recruiting
Geisinger Medical Center Danville, Pennsylvania 17822	Recruiting
Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania 17601	Recruiting
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania 17837	Recruiting
Allegheny General Hospital Pittsburgh, Pennsylvania 15212	Recruiting
West Penn Hospital Pittsburgh, Pennsylvania 15224	Recruiting
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania 18711	Suspended
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota 57104	Recruiting
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota 57117-5134	Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee 38120	Recruiting
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee 37232	Recruiting
University of Texas Health Science Center at San Antonio San Antonio, Texas 78229	Withdrawn
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah 84112	Recruiting
Valley Medical Center Renton, Washington 98055	Recruiting
Langlade Hospital and Cancer Center Antigo, Wisconsin 54409	Recruiting
Medical College of Wisconsin Milwaukee, Wisconsin 53226	Recruiting
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin 54501	Recruiting
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin 54481	Recruiting
Aspirus Regional Cancer Center Wausau, Wisconsin 54401	Recruiting
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin 54494	Recruiting

Contacts

Eric D. Miller, MD, PhD
CONTACT
614-685-4922 eric.miller@osumc.edu

Inclusion Criteria

Inclusion Criteria:

* PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma
* 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

Exclusion Criteria:

* N/A

NCT ID

NCT05673148

Date Trial Added

2023-01-06

Updated Date

2025-06-27