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

Purpose

This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with 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 (IV) (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. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/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. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.

Conditions

  • Metastatic Colorectal Adenocarcinoma
  • Stage IV Colorectal Cancer AJCC v8

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma - PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor - PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation - PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants - PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible - PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy. - Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required. - Liver-only metastatic disease is NOT permitted. For patients with liver metastases, there must be at least one other site of metastasis in addition to the liver to be eligible for this study. - Metastatic lesions must be amenable to any combination of surgical resection, microwave ablation, and/or stereotactic ablative body radiation therapy (SABR). SABR is required for at least one lesion. Therefore, the patient must be seen by a radiation oncologist in consultation to verify eligibility. - Single sites include: - Each hemiliver (right and left), each lobe of the lungs, each adrenal gland, lymph nodes amenable to a single resection or treatment in a single SABR field, bone metastases amenable to treatment in a single SABR field - PRE-REGISTRATION (STEP 0): Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 - PRE-REGISTRATION (STEP 0): A maximum of 16 weeks (4 months) of systemic therapy may be administered prior to pre-registration - REGISTRATION (STEP 1): Patients must have no overt evidence of disease progression during systemic therapy prior to registration - REGISTRATION (STEP 1): Not eligible for hepatic artery infusion pump (HAIP) therapy or benefit of HAIP therapy is undefined - REGISTRATION (STEP 1): Patients must have measurable disease per RECIST v1.1 - REGISTRATION (STEP 1): Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks (4 months) and a maximum of 24 weeks (6 months) - REGISTRATION (STEP 1): Prior definitive therapy, including adjuvant chemotherapy, must have been completed at least 12 months prior to diagnosis of metastatic disease - REGISTRATION (STEP 1): Not pregnant and not nursing, because this study involves an agent or treatment that has known genotoxic, mutagenic, and teratogenic effects. * Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required - REGISTRATION (STEP 1): Age >= 18 years - REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 - REGISTRATION (STEP 1): Absolute neutrophil count (ANC) >= 1,500/mm^3 - REGISTRATION (STEP 1): Platelet count >= 50,000/mm^3 - REGISTRATION (STEP 1): Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min * Calculated using the Cockcroft-Gault equation - REGISTRATION (STEP 1): Total bilirubin =< 1.5 x ULN - REGISTRATION (STEP 1): Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN * In the event of metastatic liver disease, =< 5 x ULN - REGISTRATION (STEP 1): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility - REGISTRATION (STEP 1): No other planned concurrent investigational agents while on study

Exclusion Criteria

  • N/A

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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: 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
  • Procedure: Computed Tomography
    Undergo CT scan
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • CT Scan
  • 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
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.
  • Drug: Chemotherapy
    Receive SOC chemotherapy
    Other names:
    • Chemo
  • Procedure: Computed Tomography
    Undergo CT scan
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • CT Scan
  • 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

Recruiting Locations

Kingman Regional Medical Center
Kingman, Arizona 86401
Contact:
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702-384-0013
research@sncrf.org

Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
Contact:
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855-776-0015

Tower Cancer Research Foundation
Beverly Hills, California 90211
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towercancerresearch@toweroncology.com

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
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877-827-8839
ucstudy@uci.edu

Cedars Sinai Medical Center
Los Angeles, California 90048
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310-423-8965

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
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877-827-8839
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Beebe Medical Center
Lewes, Delaware 19958
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302-291-6730
research@beebehealthcare.org

Beebe South Coastal Health Campus
Millville, Delaware 19967
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302-291-6730
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Helen F Graham Cancer Center
Newark, Delaware 19713
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302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
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302-623-4450
lbarone@christianacare.org

Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
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302-623-4450
lbarone@christianacare.org

Beebe Health Campus
Rehoboth Beach, Delaware 19971
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302-291-6730
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Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
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302-623-4450
lbarone@christianacare.org

George Washington University Medical Center
Washington D.C., District of Columbia 20037
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202-741-2210

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
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305-243-2647

UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida 33065
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305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
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305-243-2647

UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida 33166
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kginnity@med.miami.edu

UF Health Cancer Institute - Gainesville
Gainesville, Florida 32610
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352-273-8010

UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida 33021
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305-243-2647

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
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305-243-2647

UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
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305-243-2647

UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
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305-243-2647

Grady Health System
Atlanta, Georgia 30303
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404-778-1868

Emory Proton Therapy Center
Atlanta, Georgia 30308
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404-251-2854
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Emory University Hospital Midtown
Atlanta, Georgia 30308
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
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Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
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404-851-7115

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
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208-381-2774
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Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
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208-381-2774
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Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
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208-381-2774
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Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
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208-381-2774
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Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
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208-381-2774
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University of Illinois
Chicago, Illinois 60612
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312-355-3046

UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
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515-241-3305

University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa 52722
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563-355-7733
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Mercy Cancer Center-West Lakes
Clive, Iowa 50325
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515-241-3305

UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
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515-241-3305

Greater Regional Medical Center
Creston, Iowa 50801
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515-241-3305

Iowa Methodist Medical Center
Des Moines, Iowa 50309
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515-241-6727

UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
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515-241-3305

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
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515-241-3305

UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
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515-241-3305

University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
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800-237-1225

UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
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Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
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Baptist Health Louisville
Louisville, Kentucky 40207
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502-897-8592
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University Medical Center New Orleans
New Orleans, Louisiana 70112
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504-210-3539
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Boston Medical Center
Boston, Massachusetts 02118
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617-638-8265

Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
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734-712-7251
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
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734-712-7251
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Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
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734-712-7251
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
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734-712-7251
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Trinity Health Medical Center - Canton
Canton, Michigan 48188
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Chelsea Hospital
Chelsea, Michigan 48118
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
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Corewell Health Dearborn Hospital
Dearborn, Michigan 48124
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248-551-7695

Henry Ford Hospital
Detroit, Michigan 48202
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313-916-3721
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Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan 48336
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Genesys Hurley Cancer Institute
Flint, Michigan 48503
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810-762-8038
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Hurley Medical Center
Flint, Michigan 48503
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University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
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517-364-3712
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Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
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Henry Ford Health Providence Novi Hospital
Novi, Michigan 48374
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248-849-5332
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Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
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Henry Ford Health Providence Southfield Hospital
Southfield, Michigan 48075
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248-849-5332
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Corewell Health Beaumont Troy Hospital
Troy, Michigan 48085
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248-551-7695

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
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734-712-7251
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Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
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218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Regions Hospital
Saint Paul, Minnesota 55101
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952-993-1517
mmcorc@healthpartners.com

Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
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901-226-1366
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Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
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901-226-1366
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Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
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901-226-1366
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Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
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901-226-1366
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Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
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901-226-1366
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MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
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573-882-7440

Parkland Health Center - Farmington
Farmington, Missouri 63640
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314-996-5569

Heartland Regional Medical Center
Saint Joseph, Missouri 64506
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816-271-7937
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Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
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314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
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417-269-4520

Mercy Hospital South
St Louis, Missouri 63128
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314-525-6042
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Missouri Baptist Medical Center
St Louis, Missouri 63131
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314-996-5569

Mercy Hospital Saint Louis
St Louis, Missouri 63141
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314-251-7066

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
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314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
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314-996-5569

Billings Clinic Cancer Center
Billings, Montana 59101
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800-996-2663
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Benefis Sletten Cancer Institute
Great Falls, Montana 59405
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406-969-6060
mccinfo@mtcancer.org

Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
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402-559-6941
unmcrsa@unmc.edu

Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
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402-559-5600

University of Nebraska Medical Center
Omaha, Nebraska 68198
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402-559-6941
unmcrsa@unmc.edu

Renown Regional Medical Center
Reno, Nevada 89502
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702-384-0013
research@sncrf.org

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
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800-639-6918
cancer.research.nurse@dartmouth.edu

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
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212-639-7592

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
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212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
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212-639-7592

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
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505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York 11215
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718-780-3677
Adg9003@nyp.org

Memorial Sloan Kettering Commack
Commack, New York 11725
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212-639-7592

The New York Hospital Medical Center of Queens
Flushing, New York 11355
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888-823-5923
ctsucontact@westat.com

Northwell Health Physicians Partners Radiation Medicine at Queens
Forest Hills, New York 11375
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718-520-6620

Northwell Health Cancer Institute at Huntington
Greenlawn, New York 11740
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516-734-8896

Memorial Sloan Kettering Westchester
Harrison, New York 10604
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212-639-7592

Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
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516-734-8896

Northern Westchester Hospital
Mount Kisco, New York 10549
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914-666-1366
AMellor@northwell.edu

Mount Sinai West
New York, New York 10019
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212-824-7309
CCTO@mssm.edu

Mount Sinai Hospital
New York, New York 10029
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212-824-7309
CCTO@mssm.edu

Manhattan Eye Ear and Throat Hospital
New York, New York 10065
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212-434-4460

Memorial Sloan Kettering Cancer Center
New York, New York 10065
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212-639-7592

NYP/Weill Cornell Medical Center
New York, New York 10065
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212-746-1848

Lenox Hill Hospital
New York, New York 10075
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516-734-8896

Queens Cancer Center
Rego Park, New York 11374
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718-312-3446

Phelps Memorial Hospital Center
Sleepy Hollow, New York 10591
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914-366-1600

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
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212-639-7592

Westchester Medical Center
Valhalla, New York 10595
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888-823-5923
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Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
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800-804-9376

Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
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800-804-9376

East Carolina University
Greenville, North Carolina 27834
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252-744-1015
eubankss@ecu.edu

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
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701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Broadway Medical Center
Fargo, North Dakota 58122
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701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
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701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
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937-528-2900
clinical.trials@daytonncorp.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
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800-293-5066
Jamesline@osumc.edu

Miami Valley Hospital
Dayton, Ohio 45409
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937-528-2900
clinical.trials@daytonncorp.org

Premier Blood and Cancer Center
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320

Miami Valley Hospital North
Dayton, Ohio 45415
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Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
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937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
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Site Public Contact
937-569-7515

Upper Valley Medical Center
Troy, Ohio 45373
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Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Site Public Contact
503-494-1080
trials@ohsu.edu

Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Contact:
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302-623-4450
lbarone@christianacare.org

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
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570-271-5251
HemonCCTrials@geisinger.edu

Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Contact:
Site Public Contact
717-531-3779
CTO@hmc.psu.edu

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Contact:
Site Public Contact
877-284-2000

West Penn Hospital
Pittsburgh, Pennsylvania 15224
Contact:
Site Public Contact
412-578-5000

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
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570-271-5251
HemonCCTrials@geisinger.edu

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
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605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia 23116
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Saint Mary's Hospital
Richmond, Virginia 23226
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia 23230
Contact:
Site Public Contact
804-893-8978
Anne_caramella@bshsi.org

Valley Medical Center
Renton, Washington 98055
Contact:
Site Public Contact
425-228-3440
research@valleymed.org

Edwards Comprehensive Cancer Center
Huntington, West Virginia 25701
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304-399-6566
Christina.Cole@chhi.org

Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
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715-623-9869
Juli.Alford@aspirus.org

Ascension Saint Elizabeth Hospital
Appleton, Wisconsin 54915
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Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin 53045
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Ascension Calumet Hospital
Chilton, Wisconsin 53014
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Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin 53132
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Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin 53097
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Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee, Wisconsin 53210
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Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin 53211
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Medical College of Wisconsin
Milwaukee, Wisconsin 53226
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414-805-3666

Ascension Mercy Hospital
Oshkosh, Wisconsin 54904
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Ascension All Saints Hospital
Racine, Wisconsin 53405
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Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin 54501
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715-847-2353
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Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
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Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
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877-405-6866

Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin 53226
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Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
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715-422-7718

More Details

NCT ID
NCT05673148
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

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

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 SABR with or without surgical resection and/or microwave ablation. 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. ARM 2: Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.