AzTrials
AzTrials

Metastatic Colorectal AdenocarcinomaPhase 2NCT05673148

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

A Phase 2 study testing Stereotactic Ablative Radiotherapy, Resection and Microwave Ablation in people with Metastatic Colorectal Adenocarcinoma and Stage IV Colorectal Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 189 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stereotactic Ablative Radiotherapy, Resection and Microwave Ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
189 sitesin 2 countries
Study dates
9 Oct 2023to 12 Aug 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 36Show fewer
  • 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

Who cannot join

  • N/A

Trial locations and contacts

189 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Eric D. Miller, MD, PhD contact

614-685-4922

eric.miller@osumc.edu

189 sites in 2 countries

United States188 sites, 159 recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Benny J. Liem

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton

    Appleton, Wisconsin, 54915

    Site Public Contact, AWRI.inquiry@ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Site Public Contact, 404-778-1868

    Pretesh R. Patel

    Recruiting

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

    Site Public Contact, 404-251-2854, allyson.anderson@emory.edu

    Pretesh R. Patel

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Pretesh R. Patel

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Pretesh R. Patel

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-851-7115

    Pretesh R. Patel

    Recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

    Active, not recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Vonetta M. Williams

    Recruiting

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Kelsey A. Klute

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Saint Charles Health System

    Bend, Oregon, 97701

    Suspended

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

    Site Public Contact, 563-355-7733, katherine-daprile@uiowa.edu

    Ioannis A. Voutsadakis

    Recruiting

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

    Site Public Contact, towercancerresearch@toweroncology.com

    Jun Gong

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Suspended

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Site Public Contact, 617-638-8265

    Kimberley S. Mak

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield

    Brookfield, Wisconsin, 53045

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Site Public Contact, 718-780-3677, Adg9003@nyp.org

    Uqba Khan

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Active, not recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Christopher D. Corso

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Aslam Ejaz

    Recruiting

  • Ascension Calumet Hospital-Chilton

    Chilton, Wisconsin, 53014

    Site Public Contact, AWRI.inquiry@ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Active, not recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Active, not recruiting

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

    Site Public Contact, 573-882-7440

    Mohamed Abdelhakiem

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Aleksandar Jankov

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Eric D. Miller

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Vonetta M. Williams

    Recruiting

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

    Site Public Contact, 800-804-9376

    Christopher D. Corso

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Agustin Pimentel

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Springs

    Coral Springs, Florida, 33065

    Site Public Contact, 305-243-2647

    Agustin Pimentel

    Recruiting

  • Greater Regional Medical Center

    Creston, Iowa, 50801

    Suspended

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Austin J. Iovoli

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Active, not recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

    Site Public Contact, 248-551-7695

    Kuei C. Lee

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Agustin Pimentel

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Adam M. Forman

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

    Site Public Contact, kginnity@med.miami.edu

    Agustin Pimentel

    Recruiting

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

    Site Public Contact, 201-894-3456

    Minaxi Jhawer

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

    Site Public Contact, 248-551-7695

    Kuei C. Lee

    Recruiting

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Samir Narayan

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Samir Narayan

    Recruiting

  • The New York Hospital Medical Center of Queens

    Flushing, New York, 11355

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Jini Hyun

    Recruiting

  • Northwell Health Physicians Partners Radiation Medicine at Queens

    Forest Hills, New York, 11375

    Site Public Contact, 718-520-6620

    Sepideh Gholami

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

    Active, not recruiting

  • Ascension Southeast Wisconsin Hospital - Franklin

    Franklin, Wisconsin, 53132

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson

    Franklin, Wisconsin, 53132

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Suspended

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

    Site Public Contact, 352-273-8010

    Thomas J. George

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Northwell Health Cancer Institute at Huntington

    Greenlawn, New York, 11740

    Site Public Contact, 516-734-8896

    Sepideh Gholami

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Site Public Contact, 252-744-1015, eubankss@ecu.edu

    Aidan M. Burke

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Aleksandar Jankov

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Vonetta M. Williams

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

    Site Public Contact, 717-531-3779, CTO@hmc.psu.edu

    Zain Siddiqui

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Hollywood

    Hollywood, Florida, 33021

    Site Public Contact, 305-243-2647

    Agustin Pimentel

    Recruiting

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

    Site Public Contact, 304-399-6566, Christina.Cole@chhi.org

    Toni O. Pacioles

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Ioannis A. Voutsadakis

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Oliver S. Eng

    Recruiting

  • Allegiance Health

    Jackson, Michigan, 49201

    Active, not recruiting

  • Jupiter Medical Center

    Jupiter, Florida, 33458

    Active, not recruiting

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

    Site Public Contact, 702-384-0013, research@sncrf.org

    John A. Ellerton

    Recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Site Public Contact, 516-734-8896

    Sepideh Gholami

    Recruiting

  • Lancaster General Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

    Active, not recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Samir Narayan

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Kathryn C. Hourdequin

    Recruiting

  • Beebe Medical Center

    Lewes, Delaware, 19958

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

    Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu

    Austin J. Iovoli

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Active, not recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org

    Jun Gong

    Recruiting

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

    Site Public Contact, 502-897-8592, Cbcresearch@bhsi.com

    Benjamin Facer

    Recruiting

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Christopher Chipko

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Aleksandar Jankov

    Recruiting

  • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon

    Mequon, Wisconsin, 53097

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

    Suspended

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Agustin Pimentel

    Recruiting

  • Miami Cancer Institute

    Miami, Florida, 33176

    Active, not recruiting

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

    Site Public Contact, 305-243-2647

    Agustin Pimentel

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Vonetta M. Williams

    Recruiting

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Christopher Chipko

    Recruiting

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee

    Milwaukee, Wisconsin, 53210

    Site Public Contact, 877-405-6866, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus

    Milwaukee, Wisconsin, 53211

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Ascension Saint Francis Hospital-Milwaukee

    Milwaukee, Wisconsin, 53215

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    William A. Hall

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Vonetta M. Williams

    Recruiting

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

    Site Public Contact, 914-666-1366, AMellor@northwell.edu

    Sepideh Gholami

    Recruiting

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

    Suspended

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Site Public Contact, 800-811-8480

    Chandrasekhar Padmanabhan

    Recruiting

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

    Site Public Contact, 732-776-4240

    Gregory J. Tiesi

    Recruiting

  • Baptist Health Floyd

    New Albany, Indiana, 47150

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Benjamin Facer

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Aleksandar Jankov

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Kevin M. Sullivan

    Recruiting

  • Mount Sinai West

    New York, New York, 10019

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Karyn A. Goodman

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Karyn A. Goodman

    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

    Site Public Contact, 212-434-4460

    Sepideh Gholami

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Vonetta M. Williams

    Recruiting

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

    Site Public Contact, 212-746-1848

    Allyson J. Ocean

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10075

    Site Public Contact, 516-734-8896

    Sepideh Gholami

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Henry Ford Health Providence Novi Hospital

    Novi, Michigan, 48374

    Active, not recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Active, not recruiting

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

    Site Public Contact, 402-559-5600

    Kelsey A. Klute

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Kelsey A. Klute

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Oliver S. Eng

    Recruiting

  • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh

    Oshkosh, Wisconsin, 54904

    Site Public Contact, AWRI.inquiry@ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Aleksandar Jankov

    Recruiting

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

    Site Public Contact, 855-776-0015

    Christina S. Wu

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Site Public Contact, 877-284-2000

    Patrick L. Wagner

    Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-578-5000

    Patrick L. Wagner

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Site Public Contact, 305-243-2647

    Agustin Pimentel

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Site Public Contact, 503-494-1080, trials@ohsu.edu

    Nima Nabavizadeh

    Recruiting

  • Ascension All Saints Hospital-Spring Street-Racine

    Racine, Wisconsin, 53405

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Queens Cancer Center

    Rego Park, New York, 11374

    Site Public Contact, 718-312-3446

    Sepideh Gholami

    Recruiting

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Site Public Contact, 775-982-5050, Renown-CRD@renown.org

    John A. Ellerton

    Recruiting

  • Valley Medical Center

    Renton, Washington, 98055

    Site Public Contact, 425-228-3440, research@valleymed.org

    John A. Ellerton

    Recruiting

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginia, 23226

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Christopher Chipko

    Recruiting

  • Bon Secours Cancer Institute at Reynolds Crossing

    Richmond, Virginia, 23230

    Site Public Contact, 804-893-8978, Anne_caramella@bshsi.org

    Christopher Chipko

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Active, not recruiting

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

    Site Public Contact, 248-551-7695

    Kuei C. Lee

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Active, not recruiting

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

    Site Public Contact, 816-271-7937, Trisha.England2@mymlc.com

    Jay W. Carlson

    Recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Yan Ji

    Recruiting

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Shane Lloyd

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Withdrawn

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

    Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org

    Daniel Almquist

    Recruiting

  • Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

    Site Public Contact, 914-366-1600

    Sepideh Gholami

    Recruiting

  • Henry Ford Health Providence Southfield Hospital

    Southfield, Michigan, 48075

    Active, not recruiting

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

    Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org

    Aleksandar Jankov

    Recruiting

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Jay W. Carlson

    Recruiting

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Corewell Health Beaumont Troy Hospital

    Troy, Michigan, 48085

    Site Public Contact, 248-551-7695

    Kuei C. Lee

    Recruiting

  • Upper Valley Medical Center

    Troy, Ohio, 45373

    Suspended

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

    Suspended

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Site Public Contact, 212-639-7592

    Vonetta M. Williams

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Aviva Berkowitz

    Recruiting

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

    Active, not recruiting

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

    Site Public Contact, 202-741-2210

    Sonal Paul

    Recruiting

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Aspirus Cancer Care-Wausau

    Wausau, Wisconsin, 54401

    Site Public Contact, 877-405-6866

    Andrew J. Huang

    Recruiting

  • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa

    Wauwatosa, Wisconsin, 53226

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Wilmot Cancer Institute at Webster

    Webster, New York, 14580

    Active, not recruiting

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

    Active, not recruiting

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Austin J. Iovoli

    Recruiting

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Site Public Contact, 336-713-6771

    James Han

    Recruiting

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

    Site Public Contact, 715-422-7718

    Andrew J. Huang

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

Other trials in United States

Canada1 site

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Suspended

Other trials in Canada

About this study

Official title: A Pragmatic Randomized Phase II Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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 any combination of SABR surgical resection or microwave ablation on study. 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. Additionally, patients may undergo endoscopic exam and optional blood sample collection throughout the trial.

ARM 2: Patients receive SOC chemotherapy on study. Patients also undergo CT or MRI or PET/CT scans throughout the trial. . Additionally, patients may undergo endoscopic exam and optional blood sample collection throughout the trial.

After completion of study treatment, patients are followed for 5 years from the date of registration.

Being tested
Stereotactic Ablative Radiotherapy, Resection, Microwave Ablation, Chemotherapy, Computed Tomography
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Ablative RadiotherapyProcedure or surgery

    Also called SABER, SABR/SBRT

    Undergo SABR

  • ResectionProcedure or surgery

    Also called Surgical resection

    undergo surgical resection

  • Microwave AblationProcedure or surgery

    Also called Ablation

    undergo microwave ablation

  • ChemotherapyDrug

    Also called Chemo

    Receive SOC chemotherapy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, CT Scan

    Undergo CT scan

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan

    Undergo PET scan

Study groups in NCT05673148
Study groupRoleWhat they receive
Arm 1 (TAT, SOC chemotherapyExperimentalPatients 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.
Receives: Procedure: Stereotactic Ablative Radiotherapy; Procedure: Resection; Procedure: Microwave Ablation; Drug: Chemotherapy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography
Arm 2 (SOC chemotherapy)Active comparatorPatients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.
Receives: Drug: Chemotherapy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    • Description: The hazard ratio (HR) for OS will be estimated using a stratified Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. The Kaplan-Meier methodology will be used to estimate the median OS for each treatment arm, and Kaplan-Meier curves will be produced. OS will also be compared between treatment arms using the log rank test

    Measured: From the date of randomization to the date of death due to all causes, assessed up to 5 years

Secondary outcomes (3)

  1. Event Free Survival (EFS)

    The hazard ratio (HR) for EFS will be estimated using a stratified Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. The Kaplan-Meier methodology will be used to estimate the median EFS for each treatment arm, and Kaplan-Meier curves will be produced. EFS will also be compared between treatment arms using the log rank test.

    Measured: From randomization to the date of first documented progression, recurrence, or death due to all causes, whichever occurs first, assessed up to 5 years

  2. • Incidence of Adverse Events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0)

    Defined as the proportion of patients experienced at least one Grade 3, Grade 4, or Grade 5 of each type of AE. The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be recorded for each patient. The frequency tables will be reviewed to determine the patterns. The overall adverse event rates for grade 3 or higher adverse events will be compared between two treatment groups using Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).

    Measured: Up to 5 years

  3. Time to local recurrence (TLR)

    TLR will be measured only for patients who receive treatment with TAT and is defined as the time from the end of TAT until the date of first documented recurrence at any disease site treated with TAT. The Kaplan-Meier methodology will be used to estimate the median TLR for patients treated with TAT , and a Kaplan-Meier curve will be produced.

    Measured: from the end of TAT to the date of first documented recurrence at any disease site treated with TAT, assessed up to 5 years after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2023
  2. Study start9 Oct 2023
  3. Primary completion3 Jul 2028 (estimated)
  4. Study completion12 Aug 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673148
Sponsor's protocol ID
A022101
Other IDs
NCI-2022-09253
Status last verified
Oct 2026
First submitted
21 Dec 2022
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38350888

  • 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.

    PubMed 36652155

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic Ablative Radiotherapy, Resection and Microwave Ablation in people with Metastatic Colorectal Adenocarcinoma and Stage IV Colorectal Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 189 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric D. Miller, MD, PhD (614-685-4922, eric.miller@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From the date of randomization to the date of death due to all causes, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05673148, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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