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

September 1, 2026 updated by: Alliance for Clinical Trials in Oncology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate and compare overall survival (OS) (measured from time of randomization) in patients with newly diagnosed oligometastatic colorectal cancer (oCRC) treated with total ablative therapy (TAT) in addition to standard of care (SOC) systemic therapy versus SOC systemic therapy.

SECONDARY OBJECTIVES:

I. To evaluate and compare event-free survival (EFS) (measured from time of randomization) between the two treatment arms.

II. To assess the adverse events (AE) profile within each of the two treatment arms.

III. To evaluate the time to local recurrence (TLR) (measured from completion of TAT) in patients with newly diagnosed oCRC treated with TAT + SOC systemic therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo TAT on study, consisting of 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.

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Suspended
        • Arthur J E Child Comprehensive Cancer Centre
  • United States
    • Arizona
      • Kingman, Arizona, United States, 86401
        • Recruiting
        • Kingman Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Hospital in Arizona
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Christina S. Wu
    • California
      • Beverly Hills, California, United States, 90211
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Contact:
        • Principal Investigator:
          • Oliver S. Eng
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Jun Gong
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Oliver S. Eng
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • University of California Davis Comprehensive Cancer Center
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Recruiting
        • Beebe Medical Center
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Millville, Delaware, United States, 19967
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System-Christiana Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Wilmington, Delaware, United States, 19801
        • Recruiting
        • Christiana Care Health System-Wilmington Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Recruiting
        • George Washington University Medical Center
        • Principal Investigator:
          • Sonal Paul
        • Contact:
          • Site Public Contact
          • Phone Number: 202-741-2210
      • Washington D.C., District of Columbia, United States, 20016
        • Active, not recruiting
        • Sibley Memorial Hospital
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Agustin Pimentel
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Springs
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Agustin Pimentel
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Agustin Pimentel
      • Doral, Florida, United States, 33166
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Doral
        • Principal Investigator:
          • Agustin Pimentel
        • Contact:
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • UF Health Cancer Institute - Gainesville
        • Principal Investigator:
          • Thomas J. George
        • Contact:
          • Site Public Contact
          • Phone Number: 352-273-8010
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Hollywood
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Agustin Pimentel
      • Jupiter, Florida, United States, 33458
        • Active, not recruiting
        • Jupiter Medical Center
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Agustin Pimentel
      • Miami, Florida, United States, 33176
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Agustin Pimentel
      • Miami, Florida, United States, 33176
        • Active, not recruiting
        • Miami Cancer Institute
      • Plantation, Florida, United States, 33324
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Agustin Pimentel
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Principal Investigator:
          • Pretesh R. Patel
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Principal Investigator:
          • Pretesh R. Patel
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Principal Investigator:
          • Pretesh R. Patel
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Principal Investigator:
          • Pretesh R. Patel
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory Proton Therapy Center
        • Principal Investigator:
          • Pretesh R. Patel
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Principal Investigator:
          • Aslam Ejaz
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Baptist Health Floyd
        • Contact:
        • Principal Investigator:
          • Benjamin Facer
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Bettendorf, Iowa, United States, 52722
        • Recruiting
        • University of Iowa Healthcare Cancer Services Quad Cities
        • Contact:
        • Principal Investigator:
          • Ioannis A. Voutsadakis
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Clive, Iowa, United States, 50325
        • Recruiting
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Creston, Iowa, United States, 50801
        • Recruiting
        • Greater Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • Ioannis A. Voutsadakis
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Health Louisville
        • Contact:
        • Principal Investigator:
          • Benjamin Facer
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Kevin M. Sullivan
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Active, not recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Principal Investigator:
          • Kimberley S. Mak
        • Contact:
          • Site Public Contact
          • Phone Number: 617-638-8265
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Brighton, Michigan, United States, 48114
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Canton, Michigan, United States, 48188
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Chelsea, Michigan, United States, 48118
      • Clinton Township, Michigan, United States, 48038
        • Active, not recruiting
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, United States, 48124
        • Recruiting
        • Corewell Health Dearborn Hospital
        • Principal Investigator:
          • Kuei C. Lee
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Adam M. Forman
      • Farmington Hills, Michigan, United States, 48336
        • Recruiting
        • Corewell Health Farmington Hills Hospital
        • Principal Investigator:
          • Kuei C. Lee
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Jackson, Michigan, United States, 49201
        • Active, not recruiting
        • Allegiance Health
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Samir Narayan
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Novi, Michigan, United States, 48374
        • Active, not recruiting
        • Henry Ford Health Providence Novi Hospital
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Corewell Health William Beaumont University Hospital
        • Principal Investigator:
          • Kuei C. Lee
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
      • Southfield, Michigan, United States, 48075
        • Active, not recruiting
        • Henry Ford Health Providence Southfield Hospital
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Corewell Health Beaumont Troy Hospital
        • Principal Investigator:
          • Kuei C. Lee
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
      • West Bloomfield, Michigan, United States, 48322
        • Active, not recruiting
        • Henry Ford West Bloomfield Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Samir Narayan
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Yan Ji
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • Grenada, Mississippi, United States, 38901
        • Recruiting
        • Baptist Cancer Center-Grenada
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • New Albany, Mississippi, United States, 38652
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Union County
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • Oxford, Mississippi, United States, 38655
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Oxford
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • Southhaven, Mississippi, United States, 38671
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 573-882-7440
        • Principal Investigator:
          • Mohamed Abdelhakiem
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine-Bellevue
        • Contact:
        • Principal Investigator:
          • Kelsey A. Klute
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Kelsey A. Klute
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Contact:
          • Site Public Contact
          • Phone Number: 402-559-5600
        • Principal Investigator:
          • Kelsey A. Klute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathryn C. Hourdequin
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Vonetta M. Williams
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Englewood Hospital and Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 201-894-3456
        • Principal Investigator:
          • Minaxi Jhawer
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Vonetta M. Williams
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Vonetta M. Williams
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 732-776-4240
        • Principal Investigator:
          • Gregory J. Tiesi
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Benny J. Liem
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • New York-Presbyterian/Brooklyn Methodist Hospital
        • Principal Investigator:
          • Uqba Khan
        • Contact:
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Vonetta M. Williams
      • Flushing, New York, United States, 11355
        • Recruiting
        • The New York Hospital Medical Center of Queens
        • Principal Investigator:
          • Jini Hyun
        • Contact:
      • Forest Hills, New York, United States, 11375
        • Recruiting
        • Northwell Health Physicians Partners Radiation Medicine at Queens
        • Contact:
          • Site Public Contact
          • Phone Number: 718-520-6620
        • Principal Investigator:
          • Sepideh Gholami
      • Greenlawn, New York, United States, 11740
        • Recruiting
        • Northwell Health Cancer Institute at Huntington
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Sepideh Gholami
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Vonetta M. Williams
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Sepideh Gholami
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Northern Westchester Hospital
        • Contact:
        • Principal Investigator:
          • Sepideh Gholami
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Vonetta M. Williams
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Karyn A. Goodman
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Principal Investigator:
          • Allyson J. Ocean
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
      • New York, New York, United States, 10032
        • Active, not recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Sepideh Gholami
      • New York, New York, United States, 10065
        • Recruiting
        • Manhattan Eye Ear and Throat Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-434-4460
        • Principal Investigator:
          • Sepideh Gholami
      • New York, New York, United States, 10019
        • Recruiting
        • Mount Sinai West
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Karyn A. Goodman
      • Rego Park, New York, United States, 11374
        • Recruiting
        • Queens Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 718-312-3446
        • Principal Investigator:
          • Sepideh Gholami
      • Rochester, New York, United States, 14642
        • Active, not recruiting
        • University of Rochester
      • Sleepy Hollow, New York, United States, 10591
        • Recruiting
        • Phelps Memorial Hospital Center
        • Contact:
          • Site Public Contact
          • Phone Number: 914-366-1600
        • Principal Investigator:
          • Sepideh Gholami
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Vonetta M. Williams
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center
        • Contact:
        • Principal Investigator:
          • Aviva Berkowitz
      • Webster, New York, United States, 14580
        • Active, not recruiting
        • Wilmot Cancer Institute at Webster
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Christopher D. Corso
      • Concord, North Carolina, United States, 28025
        • Recruiting
        • Atrium Health Cabarrus/LCI-Concord
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Christopher D. Corso
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Contact:
        • Principal Investigator:
          • Aidan M. Burke
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • James Han
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Centerville, Ohio, United States, 45459
        • Active, not recruiting
        • Dayton Physicians LLC-Miami Valley South
      • Cleveland, Ohio, United States, 44109
        • Active, not recruiting
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Eric D. Miller
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Premier Blood and Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 937-276-8320
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Active, not recruiting
        • Dayton Physician LLC - Englewood
      • Franklin, Ohio, United States, 45005-1066
        • Recruiting
        • Atrium Medical Center-Middletown Regional Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Franklin, Ohio, United States, 45005
        • Active, not recruiting
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Miami Valley Cancer Care and Infusion
        • Principal Investigator:
          • Tarek M. Sabagh
        • Contact:
          • Site Public Contact
          • Phone Number: 937-569-7515
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Upper Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Active, not recruiting
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Nima Nabavizadeh
        • Contact:
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Principal Investigator:
          • Austin J. Iovoli
        • Contact:
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Zain Siddiqui
      • Lancaster, Pennsylvania, United States, 17601
        • Active, not recruiting
        • Lancaster General Ann B Barshinger Cancer Institute
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Principal Investigator:
          • Austin J. Iovoli
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-578-5000
        • Principal Investigator:
          • Patrick L. Wagner
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 877-284-2000
        • Principal Investigator:
          • Patrick L. Wagner
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Austin J. Iovoli
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Chandrasekhar Padmanabhan
    • Texas
      • San Antonio, Texas, United States, 78229
        • Withdrawn
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Shane Lloyd
    • Virginia
      • Mechanicsville, Virginia, United States, 23116
        • Recruiting
        • Bon Secours Memorial Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Christopher Chipko
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Christopher Chipko
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Christopher Chipko
      • Richmond, Virginia, United States, 23230
        • Recruiting
        • Bon Secours Cancer Institute at Reynolds Crossing
        • Contact:
        • Principal Investigator:
          • Christopher Chipko
    • Washington
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Recruiting
        • Edwards Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Toni O. Pacioles
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Aspirus Cancer Care-Antigo-Volm Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Appleton, Wisconsin, United States, 54915
        • Recruiting
        • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Brookfield, Wisconsin, United States, 53045
        • Recruiting
        • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Chilton, Wisconsin, United States, 53014
        • Recruiting
        • Ascension Calumet Hospital-Chilton
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Franklin, Wisconsin, United States, 53132
        • Recruiting
        • Ascension Southeast Wisconsin Hospital - Franklin
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Mequon, Wisconsin, United States, 53097
        • Recruiting
        • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • William A. Hall
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
      • Milwaukee, Wisconsin, United States, 53211
        • Recruiting
        • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Milwaukee, Wisconsin, United States, 53210
        • Recruiting
        • Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Racine, Wisconsin, United States, 53405
        • Recruiting
        • Ascension All Saints Hospital-Spring Street-Racine
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Rhinelander, Wisconsin, United States, 54501
        • Recruiting
        • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Aspirus Cancer Care - Stevens Point
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Cancer Care-Wausau
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
        • Principal Investigator:
          • Kamal Kant Singh Abbi
        • Contact:
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (TAT, SOC chemotherapy
Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo CT or MRI or PET/CT scans throughout the trial.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • CT Scan
Procedure: Stereotactic Ablative Radiotherapy
Undergo SABR
Other Names:
  • SABER
  • SABR/SBRT
Procedure: Resection
undergo surgical resection
Other Names:
  • Surgical resection
Procedure: Microwave Ablation
undergo microwave ablation
Other Names:
  • Ablation
Drug: Chemotherapy
Receive SOC chemotherapy
Other Names:
  • Chemo
Active Comparator: Arm 2 (SOC chemotherapy)
Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • CT Scan
Drug: Chemotherapy
Receive SOC chemotherapy
Other Names:
  • Chemo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From the date of randomization to the date of death due to all causes, assessed up to 5 years
o 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
From the date of randomization to the date of death due to all causes, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free Survival (EFS)
Time Frame: From randomization to the date of first documented progression, recurrence, or death due to all causes, whichever occurs first, assessed up to 5 years
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.
From randomization to the date of first documented progression, recurrence, or death due to all causes, whichever occurs first, assessed up to 5 years
• Incidence of Adverse Events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0)
Time Frame: Up to 5 years
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).
Up to 5 years
Time to local recurrence (TLR)
Time Frame: 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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Estimated)

July 3, 2028

Study Completion (Estimated)

August 12, 2032

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A022101
  • NCI-2022-09253 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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