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

NCT ID: NCT05673148

Condition: Metastatic Colorectal Adenocarcinoma
Stage IV Colorectal Cancer AJCC v8

Conditions: Official terms:
Colorectal Neoplasms

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Stereotactic Ablative Radiotherapy
Description: Undergo SABR
Arm group label: Arm 1 (TAT, SOC chemotherapy

Other name: SABER

Other name: SABR/SBRT

Intervention type: Procedure
Intervention name: Resection
Description: undergo surgical resection
Arm group label: Arm 1 (TAT, SOC chemotherapy

Other name: Surgical resection

Intervention type: Procedure
Intervention name: Microwave Ablation
Description: undergo microwave ablation
Arm group label: Arm 1 (TAT, SOC chemotherapy

Other name: Ablation

Intervention type: Drug
Intervention name: Chemotherapy
Description: Receive SOC chemotherapy
Arm group label: Arm 1 (TAT, SOC chemotherapy
Arm group label: Arm 2 (SOC chemotherapy)

Other name: Chemo

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo CT scan
Arm group label: Arm 1 (TAT, SOC chemotherapy
Arm group label: Arm 2 (SOC chemotherapy)

Other name: CAT

Other name: CAT Scan

Other name: Computed Axial Tomography

Other name: CT Scan

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: Undergo MRI
Arm group label: Arm 1 (TAT, SOC chemotherapy
Arm group label: Arm 2 (SOC chemotherapy)

Other name: MRI

Intervention type: Procedure
Intervention name: Positron Emission Tomography
Description: Undergo PET scan
Arm group label: Arm 1 (TAT, SOC chemotherapy
Arm group label: Arm 2 (SOC chemotherapy)

Other name: Medical Imaging, Positron Emission Tomography

Other name: PET

Other name: PET Scan

Summary: 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.

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.

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Kingman Regional Medical Center

Address:
City: Kingman
Zip: 86401
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 702-384-0013
Email: research@sncrf.org

Investigator:
Last name: John A. Ellerton
Email: Principal Investigator

Facility:
Name: Mayo Clinic Hospital in Arizona

Address:
City: Phoenix
Zip: 85054
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 855-776-0015

Investigator:
Last name: Christina S. Wu
Email: Principal Investigator

Facility:
Name: Tower Cancer Research Foundation

Address:
City: Beverly Hills
Zip: 90211
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact
Email: towercancerresearch@toweroncology.com

Investigator:
Last name: Jun Gong
Email: Principal Investigator

Facility:
Name: UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Address:
City: Irvine
Zip: 92612
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-827-8839
Email: ucstudy@uci.edu

Investigator:
Last name: Oliver S. Eng
Email: Principal Investigator

Facility:
Name: Cedars Sinai Medical Center

Address:
City: Los Angeles
Zip: 90048
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 310-423-8965

Investigator:
Last name: Jun Gong
Email: Principal Investigator

Facility:
Name: UC Irvine Health/Chao Family Comprehensive Cancer Center

Address:
City: Orange
Zip: 92868
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-827-8839
Email: ucstudy@uci.edu

Investigator:
Last name: Oliver S. Eng
Email: Principal Investigator

Facility:
Name: University of California Davis Comprehensive Cancer Center

Address:
City: Sacramento
Zip: 95817
Country: United States

Status: Active, not recruiting

Facility:
Name: Helen F Graham Cancer Center

Address:
City: Newark
Zip: 19713
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 302-623-4450
Email: lbarone@christianacare.org

Investigator:
Last name: Gregory A. Masters
Email: Principal Investigator

Facility:
Name: Medical Oncology Hematology Consultants PA

Address:
City: Newark
Zip: 19713
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 302-623-4450
Email: lbarone@christianacare.org

Investigator:
Last name: Gregory A. Masters
Email: Principal Investigator

Facility:
Name: Christiana Care Health System-Christiana Hospital

Address:
City: Newark
Zip: 19718
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 302-623-4450
Email: lbarone@christianacare.org

Investigator:
Last name: Gregory A. Masters
Email: Principal Investigator

Facility:
Name: Sibley Memorial Hospital

Address:
City: Washington
Zip: 20016
Country: United States

Status: Suspended

Facility:
Name: University of Florida Health Science Center - Gainesville

Address:
City: Gainesville
Zip: 32610
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 352-273-8010
Email: cancer-center@ufl.edu

Investigator:
Last name: Kathryn E. Hitchcock
Email: Principal Investigator

Facility:
Name: Grady Health System

Address:
City: Atlanta
Zip: 30303
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 404-489-9164

Investigator:
Last name: Pretesh R. Patel
Email: Principal Investigator

Facility:
Name: Emory Proton Therapy Center

Address:
City: Atlanta
Zip: 30308
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 404-251-2854
Email: allyson.anderson@emory.edu

Investigator:
Last name: Pretesh R. Patel
Email: Principal Investigator

Facility:
Name: Emory University Hospital Midtown

Address:
City: Atlanta
Zip: 30308
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 888-946-7447

Investigator:
Last name: Pretesh R. Patel
Email: Principal Investigator

Facility:
Name: Emory University Hospital/Winship Cancer Institute

Address:
City: Atlanta
Zip: 30322
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 404-778-1868

Investigator:
Last name: Pretesh R. Patel
Email: Principal Investigator

Facility:
Name: Emory Saint Joseph's Hospital

Address:
City: Atlanta
Zip: 30342
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 404-851-7115

Investigator:
Last name: Pretesh R. Patel
Email: Principal Investigator

Facility:
Name: Saint Luke's Cancer Institute - Boise

Address:
City: Boise
Zip: 83712
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 208-381-2774
Email: eslinget@slhs.org

Investigator:
Last name: Alison K. Conlin
Email: Principal Investigator

Facility:
Name: Saint Luke's Cancer Institute - Fruitland

Address:
City: Fruitland
Zip: 83619
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 208-381-2774
Email: eslinget@slhs.org

Investigator:
Last name: Alison K. Conlin
Email: Principal Investigator

Facility:
Name: Saint Luke's Cancer Institute - Meridian

Address:
City: Meridian
Zip: 83642
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 208-381-2774
Email: eslinget@slhs.org

Investigator:
Last name: Alison K. Conlin
Email: Principal Investigator

Facility:
Name: Saint Luke's Cancer Institute - Nampa

Address:
City: Nampa
Zip: 83686
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 208-381-2774
Email: eslinget@slhs.org

Investigator:
Last name: Alison K. Conlin
Email: Principal Investigator

Facility:
Name: Saint Luke's Cancer Institute - Twin Falls

Address:
City: Twin Falls
Zip: 83301
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 208-381-2774
Email: eslinget@slhs.org

Investigator:
Last name: Alison K. Conlin
Email: Principal Investigator

Facility:
Name: University of Illinois

Address:
City: Chicago
Zip: 60612
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 312-355-3046

Investigator:
Last name: Aslam Ejaz
Email: Principal Investigator

Facility:
Name: Mission Cancer and Blood - Ankeny

Address:
City: Ankeny
Zip: 50023
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-282-2921

Investigator:
Last name: Richard L. Deming
Email: Principal Investigator

Facility:
Name: Mercy Cancer Center-West Lakes

Address:
City: Clive
Zip: 50325
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-358-6613
Email: cancerresearch@mercydesmoines.org

Investigator:
Last name: Richard L. Deming
Email: Principal Investigator

Facility:
Name: Mission Cancer and Blood - West Des Moines

Address:
City: Clive
Zip: 50325
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-241-3305

Investigator:
Last name: Richard L. Deming
Email: Principal Investigator

Facility:
Name: Greater Regional Medical Center

Address:
City: Creston
Zip: 50801
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-358-6613
Email: cancerresearch@mercydesmoines.org

Investigator:
Last name: Richard L. Deming
Email: Principal Investigator

Facility:
Name: Iowa Methodist Medical Center

Address:
City: Des Moines
Zip: 50309
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-241-6727

Investigator:
Last name: Seema Harichand-Herdt
Email: Principal Investigator

Facility:
Name: Mission Cancer and Blood - Des Moines

Address:
City: Des Moines
Zip: 50309
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-241-3305

Investigator:
Last name: Seema Harichand-Herdt
Email: Principal Investigator

Facility:
Name: Mercy Medical Center - Des Moines

Address:
City: Des Moines
Zip: 50314
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-358-6613
Email: cancerresearch@mercydesmoines.org

Investigator:
Last name: Richard L. Deming
Email: Principal Investigator

Facility:
Name: Mission Cancer and Blood - Laurel

Address:
City: Des Moines
Zip: 50314
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-241-3305

Investigator:
Last name: Richard L. Deming
Email: Principal Investigator

Facility:
Name: Mercy Medical Center-West Lakes

Address:
City: West Des Moines
Zip: 50266
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-358-6613
Email: cancerresearch@mercydesmoines.org

Investigator:
Last name: Richard L. Deming
Email: Principal Investigator

Facility:
Name: University of Kentucky/Markey Cancer Center

Address:
City: Lexington
Zip: 40536
Country: United States

Status: Active, not recruiting

Facility:
Name: Johns Hopkins University/Sidney Kimmel Cancer Center

Address:
City: Baltimore
Zip: 21287
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 410-955-8804
Email: jhcccro@jhmi.edu

Investigator:
Last name: Eric Christenson
Email: Principal Investigator

Facility:
Name: Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Address:
City: Ann Arbor
Zip: 48106
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology - Brighton

Address:
City: Brighton
Zip: 48114
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Trinity Health Medical Center - Brighton

Address:
City: Brighton
Zip: 48114
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology - Canton

Address:
City: Canton
Zip: 48188
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Trinity Health Medical Center - Canton

Address:
City: Canton
Zip: 48188
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Chelsea Hospital

Address:
City: Chelsea
Zip: 48118
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Address:
City: Chelsea
Zip: 48118
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Corewell Health Dearborn Hospital

Address:
City: Dearborn
Zip: 48124
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-551-7695

Investigator:
Last name: Kuei C. Lee
Email: Principal Investigator

Facility:
Name: Henry Ford Hospital

Address:
City: Detroit
Zip: 48202
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 313-916-3721
Email: CTOResearch@hfhs.org

Investigator:
Last name: Parag J. Parikh
Email: Principal Investigator

Facility:
Name: Corewell Health Farmington Hills Hospital

Address:
City: Farmington Hills
Zip: 48336
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-551-7695

Investigator:
Last name: Kuei C. Lee
Email: Principal Investigator

Facility:
Name: Genesys Hurley Cancer Institute

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Hurley Medical Center

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: University of Michigan Health - Sparrow Lansing

Address:
City: Lansing
Zip: 48912
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 517-364-3712
Email: harsha.trivedi@umhsparrow.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Trinity Health Saint Mary Mercy Livonia Hospital

Address:
City: Livonia
Zip: 48154
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Henry Ford Health Providence Novi Hospital

Address:
City: Novi
Zip: 48374
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-849-5332
Email: kfife3@hfhs.org

Investigator:
Last name: Adam M. Forman
Email: Principal Investigator

Facility:
Name: Corewell Health William Beaumont University Hospital

Address:
City: Royal Oak
Zip: 48073
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-551-7695

Investigator:
Last name: Kuei C. Lee
Email: Principal Investigator

Facility:
Name: Henry Ford Health Providence Southfield Hospital

Address:
City: Southfield
Zip: 48075
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-849-5332
Email: kfife3@hfhs.org

Investigator:
Last name: Adam M. Forman
Email: Principal Investigator

Facility:
Name: Corewell Health Beaumont Troy Hospital

Address:
City: Troy
Zip: 48085
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-551-7695

Investigator:
Last name: Kuei C. Lee
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Address:
City: Ypsilanti
Zip: 48197
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Samir Narayan
Email: Principal Investigator

Facility:
Name: Sanford Joe Lueken Cancer Center

Address:
City: Bemidji
Zip: 56601
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-333-5000
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Investigator:
Last name: Daniel Almquist
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Golden Triangle

Address:
City: Columbus
Zip: 39705
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Aleksandar Jankov
Email: Principal Investigator

Facility:
Name: Baptist Cancer Center-Grenada

Address:
City: Grenada
Zip: 38901
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Aleksandar Jankov
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Union County

Address:
City: New Albany
Zip: 38652
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Aleksandar Jankov
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Oxford

Address:
City: Oxford
Zip: 38655
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Aleksandar Jankov
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Desoto

Address:
City: Southhaven
Zip: 38671
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Aleksandar Jankov
Email: Principal Investigator

Facility:
Name: Mercy Hospital Saint Louis

Address:
City: Saint Louis
Zip: 63141
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 314-251-7066

Investigator:
Last name: Jay W. Carlson
Email: Principal Investigator

Facility:
Name: Billings Clinic Cancer Center

Address:
City: Billings
Zip: 59101
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-996-2663
Email: research@billingsclinic.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Benefis Sletten Cancer Institute

Address:
City: Great Falls
Zip: 59405
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Nebraska Medicine-Bellevue

Address:
City: Bellevue
Zip: 68123
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 402-559-6941
Email: unmcrsa@unmc.edu

Investigator:
Last name: Laura L. Tenner
Email: Principal Investigator

Facility:
Name: Nebraska Medicine-Village Pointe

Address:
City: Omaha
Zip: 68118
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 402-559-5600

Investigator:
Last name: Laura L. Tenner
Email: Principal Investigator

Facility:
Name: University of Nebraska Medical Center

Address:
City: Omaha
Zip: 68198
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 402-559-6941
Email: unmcrsa@unmc.edu

Investigator:
Last name: Laura L. Tenner
Email: Principal Investigator

Facility:
Name: Renown Regional Medical Center

Address:
City: Reno
Zip: 89502
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 702-384-0013
Email: research@sncrf.org

Investigator:
Last name: John A. Ellerton
Email: Principal Investigator

Facility:
Name: Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Address:
City: Lebanon
Zip: 03756
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Investigator:
Last name: Kathryn C. Hourdequin
Email: Principal Investigator

Facility:
Name: Memorial Sloan Kettering Basking Ridge

Address:
City: Basking Ridge
Zip: 07920
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-639-7592

Investigator:
Last name: Vonetta M. Williams
Email: Principal Investigator

Facility:
Name: Memorial Sloan Kettering Monmouth

Address:
City: Middletown
Zip: 07748
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-639-7592

Investigator:
Last name: Vonetta M. Williams
Email: Principal Investigator

Facility:
Name: Memorial Sloan Kettering Bergen

Address:
City: Montvale
Zip: 07645
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-639-7592

Investigator:
Last name: Vonetta M. Williams
Email: Principal Investigator

Facility:
Name: University of New Mexico Cancer Center

Address:
City: Albuquerque
Zip: 87106
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 505-925-0348
Email: HSC-ClinicalTrialInfo@salud.unm.edu

Investigator:
Last name: Benny J. Liem
Email: Principal Investigator

Facility:
Name: New York-Presbyterian/Brooklyn Methodist Hospital

Address:
City: Brooklyn
Zip: 11215
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 718-780-3677
Email: Adg9003@nyp.org

Investigator:
Last name: Uqba Khan
Email: Principal Investigator

Facility:
Name: Memorial Sloan Kettering Commack

Address:
City: Commack
Zip: 11725
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-639-7592

Investigator:
Last name: Vonetta M. Williams
Email: Principal Investigator

Facility:
Name: The New York Hospital Medical Center of Queens

Address:
City: Flushing
Zip: 11355
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 888-823-5923
Email: ctsucontact@westat.com

Investigator:
Last name: Jini Hyun
Email: Principal Investigator

Facility:
Name: Northwell Health Physicians Partners Radiation Medicine at Queens

Address:
City: Forest Hills
Zip: 11375
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 718-520-6620

Investigator:
Last name: Sepideh Gholami
Email: Principal Investigator

Facility:
Name: Northwell Health Cancer Institute at Huntington

Address:
City: Greenlawn
Zip: 11740
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 516-734-8896

Investigator:
Last name: Sepideh Gholami
Email: Principal Investigator

Facility:
Name: Memorial Sloan Kettering Westchester

Address:
City: Harrison
Zip: 10604
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-639-7592

Investigator:
Last name: Vonetta M. Williams
Email: Principal Investigator

Facility:
Name: Northwell Health/Center for Advanced Medicine

Address:
City: Lake Success
Zip: 11042
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 516-734-8896

Investigator:
Last name: Sepideh Gholami
Email: Principal Investigator

Facility:
Name: Northern Westchester Hospital

Address:
City: Mount Kisco
Zip: 10549
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 914-666-1366
Email: AMellor@northwell.edu

Investigator:
Last name: Sepideh Gholami
Email: Principal Investigator

Facility:
Name: Mount Sinai West

Address:
City: New York
Zip: 10019
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-824-7309
Email: CCTO@mssm.edu

Investigator:
Last name: Karyn A. Goodman
Email: Principal Investigator

Facility:
Name: Lenox Hill Hospital

Address:
City: New York
Zip: 10021
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 516-734-8896

Investigator:
Last name: Sepideh Gholami
Email: Principal Investigator

Facility:
Name: Mount Sinai Hospital

Address:
City: New York
Zip: 10029
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-824-7309
Email: CCTO@mssm.edu

Investigator:
Last name: Karyn A. Goodman
Email: Principal Investigator

Facility:
Name: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Address:
City: New York
Zip: 10032
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-342-5162
Email: cancerclinicaltrials@cumc.columbia.edu

Investigator:
Last name: David P. Horowitz
Email: Principal Investigator

Facility:
Name: Manhattan Eye Ear and Throat Hospital

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-434-4460

Investigator:
Last name: Sepideh Gholami
Email: Principal Investigator

Facility:
Name: Memorial Sloan Kettering Cancer Center

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-639-7592

Investigator:
Last name: Vonetta M. Williams
Email: Principal Investigator

Facility:
Name: NYP/Weill Cornell Medical Center

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-746-1848

Investigator:
Last name: Allyson J. Ocean
Email: Principal Investigator

Facility:
Name: Queens Cancer Center

Address:
City: Rego Park
Zip: 11374
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 718-312-3446

Investigator:
Last name: Sepideh Gholami
Email: Principal Investigator

Facility:
Name: University of Rochester

Address:
City: Rochester
Zip: 14642
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 585-275-5830

Investigator:
Last name: Yuhchyau Chen
Email: Principal Investigator

Facility:
Name: Memorial Sloan Kettering Nassau

Address:
City: Uniondale
Zip: 11553
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 212-639-7592

Investigator:
Last name: Vonetta M. Williams
Email: Principal Investigator

Facility:
Name: Westchester Medical Center

Address:
City: Valhalla
Zip: 10595
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 888-823-5923
Email: ctsucontact@westat.com

Investigator:
Last name: Aviva Berkowitz
Email: Principal Investigator

Facility:
Name: Wilmot Cancer Institute at Webster

Address:
City: Webster
Zip: 14580
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact
Email: WCICTOresearch@urmc.rochester.edu

Investigator:
Last name: Yuhchyau Chen
Email: Principal Investigator

Facility:
Name: Sanford Bismarck Medical Center

Address:
City: Bismarck
Zip: 58501
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Investigator:
Last name: Daniel Almquist
Email: Principal Investigator

Facility:
Name: Sanford Broadway Medical Center

Address:
City: Fargo
Zip: 58122
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Investigator:
Last name: Daniel Almquist
Email: Principal Investigator

Facility:
Name: Sanford Roger Maris Cancer Center

Address:
City: Fargo
Zip: 58122
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 701-234-6161
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Investigator:
Last name: Daniel Almquist
Email: Principal Investigator

Facility:
Name: Dayton Physicians LLC-Miami Valley South

Address:
City: Centerville
Zip: 45459
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Howard M. Gross
Email: Principal Investigator

Facility:
Name: Miami Valley Hospital South

Address:
City: Centerville
Zip: 45459
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: MetroHealth Medical Center

Address:
City: Cleveland
Zip: 44109
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 216-778-7559
Email: ababal@metrohealth.org

Investigator:
Last name: Suzanne M. Russo
Email: Principal Investigator

Facility:
Name: Ohio State University Comprehensive Cancer Center

Address:
City: Columbus
Zip: 43210
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-293-5066
Email: Jamesline@osumc.edu

Investigator:
Last name: Eric D. Miller
Email: Principal Investigator

Facility:
Name: Miami Valley Hospital

Address:
City: Dayton
Zip: 45409
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Premier Blood and Cancer Center

Address:
City: Dayton
Zip: 45409
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-276-8320

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Dayton Physician LLC - Englewood

Address:
City: Dayton
Zip: 45415
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Howard M. Gross
Email: Principal Investigator

Facility:
Name: Miami Valley Hospital North

Address:
City: Dayton
Zip: 45415
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Atrium Medical Center-Middletown Regional Hospital

Address:
City: Franklin
Zip: 45005-1066
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Dayton Physicians LLC-Atrium

Address:
City: Franklin
Zip: 45005
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Howard M. Gross
Email: Principal Investigator

Facility:
Name: Miami Valley Cancer Care and Infusion

Address:
City: Greenville
Zip: 45331
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-569-7515

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Upper Valley Medical Center

Address:
City: Troy
Zip: 45373
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: University of Oklahoma Health Sciences Center

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Investigator:
Last name: Sagila George
Email: Principal Investigator

Facility:
Name: Christiana Care Health System-Concord Health Center

Address:
City: Chadds Ford
Zip: 19317
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 302-623-4450
Email: lbarone@christianacare.org

Investigator:
Last name: Gregory A. Masters
Email: Principal Investigator

Facility:
Name: Geisinger Medical Center

Address:
City: Danville
Zip: 17822
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu

Investigator:
Last name: Alfred D. Christie
Email: Principal Investigator

Facility:
Name: Geisinger Medical Oncology-Lewisburg

Address:
City: Lewisburg
Zip: 17837
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu

Investigator:
Last name: Alfred D. Christie
Email: Principal Investigator

Facility:
Name: Allegheny General Hospital

Address:
City: Pittsburgh
Zip: 15212
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-284-2000

Investigator:
Last name: Patrick L. Wagner
Email: Principal Investigator

Facility:
Name: West Penn Hospital

Address:
City: Pittsburgh
Zip: 15224
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 412-578-5000

Investigator:
Last name: Patrick L. Wagner
Email: Principal Investigator

Facility:
Name: Geisinger Wyoming Valley/Henry Cancer Center

Address:
City: Wilkes-Barre
Zip: 18711
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu

Investigator:
Last name: Alfred D. Christie
Email: Principal Investigator

Facility:
Name: Sanford Cancer Center Oncology Clinic

Address:
City: Sioux Falls
Zip: 57104
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 605-312-3320
Email: OncologyClinicTrialsSF@sanfordhealth.org

Investigator:
Last name: Daniel Almquist
Email: Principal Investigator

Facility:
Name: Sanford USD Medical Center - Sioux Falls

Address:
City: Sioux Falls
Zip: 57117-5134
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Investigator:
Last name: Daniel Almquist
Email: Principal Investigator

Facility:
Name: Baptist Memorial Hospital and Cancer Center-Memphis

Address:
City: Memphis
Zip: 38120
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Investigator:
Last name: Aleksandar Jankov
Email: Principal Investigator

Facility:
Name: Vanderbilt University/Ingram Cancer Center

Address:
City: Nashville
Zip: 37232
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-811-8480

Investigator:
Last name: Chandrasekhar Padmanabhan
Email: Principal Investigator

Facility:
Name: University of Texas Health Science Center at San Antonio

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu

Investigator:
Last name: Neil Newman
Email: Principal Investigator

Facility:
Name: Huntsman Cancer Institute/University of Utah

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Investigator:
Last name: Shane Lloyd
Email: Principal Investigator

Facility:
Name: Valley Medical Center

Address:
City: Renton
Zip: 98055
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 425-228-3440
Email: research@valleymed.org

Investigator:
Last name: John A. Ellerton
Email: Principal Investigator

Facility:
Name: Langlade Hospital and Cancer Center

Address:
City: Antigo
Zip: 54409
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 715-623-9869
Email: Juli.Alford@aspirus.org

Investigator:
Last name: Andrew J. Huang
Email: Principal Investigator

Facility:
Name: Medical College of Wisconsin

Address:
City: Milwaukee
Zip: 53226
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 414-805-3666

Investigator:
Last name: William A. Hall
Email: Principal Investigator

Facility:
Name: Ascension Saint Mary's Hospital

Address:
City: Rhinelander
Zip: 54501
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 715-847-2353
Email: Beth.Knetter@aspirus.org

Investigator:
Last name: Andrew J. Huang
Email: Principal Investigator

Facility:
Name: Ascension Saint Michael's Hospital

Address:
City: Stevens Point
Zip: 54481
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 715-847-2353
Email: Beth.Knetter@aspirus.org

Investigator:
Last name: Andrew J. Huang
Email: Principal Investigator

Facility:
Name: Aspirus Cancer Care - Wisconsin Rapids

Address:
City: Wisconsin Rapids
Zip: 54494
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 715-422-7718

Investigator:
Last name: Andrew J. Huang
Email: Principal Investigator

Start date: January 10, 2023

Completion date: August 12, 2032

Lead sponsor:
Agency: Alliance for Clinical Trials in Oncology
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Alliance for Clinical Trials in Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05673148

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