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

No

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.

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
Sibley Memorial Hospital
Washington, District of Columbia 20016
Suspended
University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
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
Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Recruiting
Mission Cancer and Blood - West Des Moines
Clive, Iowa 50325
Recruiting
Greater Regional Medical Center
Creston, Iowa 50801
Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Recruiting
Mission Cancer and Blood - Des Moines
Des Moines, Iowa 50309
Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Recruiting
Mission Cancer and Blood - Laurel
Des Moines, Iowa 50314
Recruiting
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Active, not recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
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
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
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
Suspended
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
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
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
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Recruiting
Mercy Hospital Springfield
Springfield, Missouri 65804
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
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
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
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
Recruiting
Memorial Sloan Kettering Westchester
West Harrison, New York 10604
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
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
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
Recruiting
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
Active, not recruiting
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 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

2025-01-13