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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Alliance for Clinical Trials in Oncology • ClinicalTrials.gov ID: NCT05673148

Registry updated: 2026-10-02
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Description

This phase III trial compares the addition of total ablative therapy to the usual systemic therapy versus the usual systemic therapy alone in treating patients with advanced 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 (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. The ablative local therapy will consist of any combination of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR), surgical resection, 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. The addition of ablative local therapy to the usual approach of systemic therapy could be more effective than usual chemotherapy alone by increasing the life of patients with limited metastatic colorectal cancer.

Interventions

  • Stereotactic Ablative Radiotherapy (Procedure)
    Undergo SABR
  • Resection (Procedure)
    undergo surgical resection
  • Microwave Ablation (Procedure)
    undergo microwave ablation
  • Chemotherapy (Drug)
    Receive SOC chemotherapy
  • Computed Tomography (Procedure)
    Undergo CT scan
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Positron Emission Tomography (Procedure)
    Undergo PET scan

Eligibility criteria

Inclusion Criteria: * Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom) * PRE-REGISTRATION (STEP 0): Pathologically proven diagnosis of metastatic colorectal adenocarcinoma with metastases (biopsy from primary tumor or metastatic site is acceptable) * 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): Liver-only metastatic disease on baseline imaging prior to starting chemotherapy is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver on initial imaging to be eligible for this study. Of note, patients who have metastatic disease to the liver and at least one other site on initial imaging who have liver-only metastatic disease on subsequent imaging after completing initial systemic therapy are eligible * PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 * REGISTRATION (STEP 1): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * REGISTRATION (STEP 1): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * REGISTRATION (STEP 1): A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * 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): Primary tumor is already resected OR patient has had a clinical complete response without surgical resection and no local regrowth (primary rectal tumors only) OR primary tumor is amenable to surgical 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 * REGISTRATION (STEP 1): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of radiographic imaging obtained following at least 12 weeks of systemic therapy. Of note, the primary tumor and associated regional lymph nodes do not count as one of the sites of disease. * Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required. * Metastatic lesions must be amenable to surgical resection, microwave ablation, radiationSABR or any combination of these modalities. * Subcentimeter indeterminate lesions such as lung nodules \< 5 mm in size may be considered metastases unless there are \> 2 months of documented stability prior to the initiation of systemic * 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. * 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 12 weeks and a maximum of 52 weeks * REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 6 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) \>= 1,000/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 \* If Gilbert's disease, use direct bilirubin instead of total bilirubin; direct bilirubin =\< 1.5 ULN if patient to receive FOLFIRI (leucovorin calcium, 5-fluorouracil, and irinotecan); direct bilirubin ≤ 3.0 x ULN if patient to receive mFOLFOX6 (leucovorin calcium, 5-fluorouracil, and oxaliplatin) * 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: * N/A

Conditions

Metastatic Colorectal Adenocarcinoma Stage IV Colorectal Cancer AJCC v8 Oligometastatic Colorectal Carcinoma

Locations

  • 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
  • Baptist Health Floyd — New Albany, Indiana, 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
  • 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
  • Englewood Hospital and Medical Center — Englewood, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Jersey Shore Medical Center — Neptune City, 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
  • Wake Forest University Health Sciences — Winston-Salem, 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
  • Saint Charles Health System — Bend, Oregon, 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
  • Aspirus Cancer Care-Antigo-Volm Cancer Center — Antigo, Wisconsin, United States
  • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton — Appleton, Wisconsin, United States
  • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield — Brookfield, Wisconsin, United States
  • Ascension Calumet Hospital-Chilton — Chilton, Wisconsin, United States
  • Ascension Southeast Wisconsin Hospital - Franklin — Franklin, Wisconsin, United States
  • Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson — Franklin, Wisconsin, United States
  • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon — Mequon, Wisconsin, United States
  • Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee — Milwaukee, Wisconsin, United States
  • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus — Milwaukee, Wisconsin, United States
  • Ascension Saint Francis Hospital-Milwaukee — Milwaukee, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh — Oshkosh, Wisconsin, United States
  • Ascension All Saints Hospital-Spring Street-Racine — Racine, Wisconsin, United States
  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center — Rhinelander, Wisconsin, United States
  • Aspirus Cancer Care - Stevens Point — Stevens Point, Wisconsin, United States
  • Aspirus Cancer Care-Wausau — Wausau, Wisconsin, United States
  • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa — Wauwatosa, Wisconsin, United States
  • Aspirus Cancer Care - Wisconsin Rapids — Wisconsin Rapids, Wisconsin, United States
  • Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record