Last updated on August 2018

Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer


Brief description of study

This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. (Phase II-R) II. To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS). (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate treated metastasis control according to tumor receptor status (estrogen receptor [ER], progesterone receptor [PR], human epidermal growth factor receptor [HER]-2), use of chemotherapy, surgery vs. ablative therapy, and solitary metastasis vs. 2 metastasis (may expand to >= 2 to =< 4 following completion of a Phase I trial).

II. To evaluate whether the addition of ablative metastasis directed therapy significantly reduces the number of distant recurrences (new metastases) in patients who progress according to tumor receptor status (ER, PR, HER-2); use of chemotherapy, and solitary metastasis vs. 2 metastases (may expand to >= 2 to =< 4 following completion of the Phase I NRG-BR001 trial).

III. To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy alone.

IV. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout the radiation therapy processes, including imaging, simulation, target and critical structure definition, treatment planning, image guidance, and delivery.

TERTIARY OBJECTIVES:

I. To determine whether < 5 circulating tumor cells (CTCs) (per 7.5 ml of blood) is an independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast cancer.

II. To determine whether < 5 CTCs (per 7.5 ml of blood) is an independent predictive (response to therapy) marker for improved PFS and OS in oligometastatic breast cancer.

III. To determine whether eliminating CTCs (0/7.5 ml of blood in patients with at least 2 CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS.

IV. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS.

V. To store material for retrospective analysis of circulating tumor deoxyribonucleic acid (ctDNA).

VI. To store material for retrospective analysis of circulating micro-ribonucleic acid (RNA).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician.

ARM 2: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician. Patients also undergo stereotactic radiosurgery in 1, 3, or 5 fractions within 3 weeks and/or surgery at the discretion of the treating physician.

ARM 1: Patients are followed every 3 months from randomization to 2 years. ARM 2: Patients are followed 25-35 days post-ablation, every 3 months from randomization to 2 years, and then yearly thereafter.

Clinical Study Identifier: NCT02364557

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Jennifer F. De Los Santos

University of Alabama at Birmingham Cancer Center
Birmingham, AL United States
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Arizona Center for Cancer Care-Peoria
Peoria, AZ United States
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Victor J. Gonzalez

University of Arizona Cancer Center-Orange Grove Campus
Tucson, AZ United States
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Victor J. Gonzalez

The University of Arizona Medical Center-University Campus
Tucson, AZ United States
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UC San Diego Moores Cancer Center
La Jolla, CA United States
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Jason C. Ye

USC / Norris Comprehensive Cancer Center
Los Angeles, CA United States
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Parima Daroui

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, CA United States
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Samantha A. Seaward

The Permanente Medical Group-Roseville Radiation Oncology
Roseville, CA United States
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Oleg I. Krijanovski

Sutter Medical Center Sacramento
Sacramento, CA United States
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Megan E. Daly

University of California Davis Comprehensive Cancer Center
Sacramento, CA United States
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Harvey B. Wilds

Naval Medical Center -San Diego
San Diego, CA United States
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Samantha A. Seaward

Kaiser Permanente Cancer Treatment Center
South San Francisco, CA United States
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Rachel A. Rabinovitch

University of Colorado Hospital
Aurora, CO United States
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Mehmet S. Copur

Penrose-Saint Francis Healthcare
Colorado Springs, CO United States
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Rachel A. Rabinovitch

Poudre Valley Hospital
Fort Collins, CO United States
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Keren Sturtz

McKee Medical Center
Loveland, CO United States
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University of Florida Health Science Center - Gainesville
Gainesville, FL United States
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Srinath Sundararaman

Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, FL United States
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Patrick Kelly

UF Cancer Center at Orlando Health
Orlando, FL United States
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Srinath Sundararaman

Memorial Hospital West
Pembroke Pines, FL United States
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Shannon T. Kahn

Emory University Hospital Midtown
Atlanta, GA United States
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Piedmont Hospital
Atlanta, GA United States
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Shannon T. Kahn

Emory University Hospital/Winship Cancer Institute
Atlanta, GA United States
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Shannon T. Kahn

Emory Saint Joseph's Hospital
Atlanta, GA United States
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Kenneth N. Sumida

Queen's Medical Center
Honolulu, HI United States
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Jonathan B. Strauss

Northwestern University
Chicago, IL United States
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Parul N. Barry

Rush University Medical Center
Chicago, IL United States
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Kent F. Hoskins

University of Illinois
Chicago, IL United States
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Bryan A. Faller

Decatur Memorial Hospital
Decatur, IL United States
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Loyola University Medical Center
Maywood, IL United States
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Bryan A. Faller

Memorial Medical Center
Springfield, IL United States
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Sinisa Stanic

Carle Cancer Center
Urbana, IL United States
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Christy M. Kesslering

Northwestern Medicine Cancer Center Warrenville
Warrenville, IL United States
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Alexander M. Yeh

Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, IN United States
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Brian K. Chang

Parkview Hospital Randallia
Fort Wayne, IN United States
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David A. Hornback

Memorial Hospital of South Bend
South Bend, IN United States
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Shaker R. Dakhil

Via Christi Regional Medical Center
Wichita, KS United States
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Owensboro Health Mitchell Memorial Cancer Center
Owensboro, KY United States
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Matthew D. Cheney

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, ME United States
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Matthew D. Cheney

Maine Medical Center-Bramhall Campus
Portland, ME United States
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Matthew D. Cheney

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, ME United States
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Matthew D. Cheney

Maine Medical Center- Scarborough Campus
Scarborough, ME United States
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Sally B. Cheston

University of Maryland/Greenebaum Cancer Center
Baltimore, MD United States
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Mark V. Mishra

Upper Chesapeake Medical Center
Bel Air, MD United States
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Sally B. Cheston

Central Maryland Radiation Oncology in Howard County
Columbia, MD United States
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Andrea B. McKee

Lahey Hospital and Medical Center
Burlington, MA United States
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Reshma Jagsi

University of Michigan Comprehensive Cancer Center
Ann Arbor, MI United States
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Eleanor M. Walker

Henry Ford Cancer Institute?Downriver
Brownstown, MI United States
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Eleanor M. Walker

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, MI United States
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Eleanor M. Walker

Henry Ford Hospital
Detroit, MI United States
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Samir Narayan

Saint Joseph Mercy Oakland
Pontiac, MI United States
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Peter Y. Chen

William Beaumont Hospital-Royal Oak
Royal Oak, MI United States
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Eleanor M. Walker

Henry Ford West Bloomfield Hospital
West Bloomfield, MI United States
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Steven R. Bonin

Saint Luke's Hospital of Duluth
Duluth, MN United States
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Kimberly S. Corbin

Mayo Clinic
Rochester, MN United States
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Imran Zoberi

Washington University School of Medicine
Saint Louis, MO United States
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Bryan A. Faller

Missouri Baptist Medical Center
Saint Louis, MO United States
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University of Nebraska Medical Center
Omaha, NE United States
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Michael C. Hardacre

Renown Regional Medical Center
Reno, NV United States
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Dartmouth Hitchcock Medical Center
Lebanon, NH United States
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Virtua Memorial
Mount Holly, NJ United States
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David J. D'Ambrosio

Community Medical Center
Toms River, NJ United States
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Virtua Voorhees
Voorhees, NJ United States
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Gregory N. Gan

University of New Mexico Cancer Center
Albuquerque, NM United States
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Gregory N. Gan

New Mexico Oncology Hematology Consultants
Albuquerque, NM United States
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Montefiore Medical Center - Moses Campus
Bronx, NY United States
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Eileen P. Connolly

Columbia University/Herbert Irving Cancer Center
New York, NY United States
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Yuhchyau Chen

University of Rochester
Rochester, NY United States
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Dickstein Cancer Treatment Center
White Plains, NY United States
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Achilles J. Fakiris

Rex Hematology Oncology Associates-Cary
Cary, NC United States
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, NC United States
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Joseph K. Salama

Duke University Medical Center
Durham, NC United States
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Achilles J. Fakiris

Rex Hematology Oncology Associates-Garner
Garner, NC United States
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Achilles J. Fakiris

Rex Cancer Center
Raleigh, NC United States
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Achilles J. Fakiris

Rex Hematology Oncology Associates-Blue Ridge
Raleigh, NC United States
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Doris R. Brown

Wake Forest University Health Sciences
Winston-Salem, NC United States
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Sanford Bismarck Medical Center
Bismarck, ND United States
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Case Western Reserve University
Cleveland, OH United States
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Jose G. Bazan

Ohio State University Comprehensive Cancer Center
Columbus, OH United States
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J. S. Thompson

University of Oklahoma Health Sciences Center
Oklahoma City, OK United States
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Dwight E. Heron

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, PA United States
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University of Pennsylvania/Abramson Cancer Center
Philadelphia, PA United States
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Mark G. Trombetta

Allegheny General Hospital
Pittsburgh, PA United States
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Terrence P. Cescon

Reading Hospital
West Reading, PA United States
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Jennifer L. Harper

Self Regional Healthcare
Greenwood, SC United States
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Steven W. Corso

Spartanburg Medical Center
Spartanburg, SC United States
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Texas Oncology-Austin Midtown
Austin, TX United States
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Asal S. Rahimi

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, TX United States
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Wendy A. Woodward

M D Anderson Cancer Center
Houston, TX United States
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Brandon J. Fisher

Ogden Regional Medical Center
Ogden, UT United States
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Huntsman Cancer Institute/University of Utah
Salt Lake City, UT United States
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Ashish K. Chawla

Inova Fairfax Hospital
Falls Church, VA United States
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William J. Irvin

Bon Secours Saint Mary's Hospital
Richmond, VA United States
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Maria R. Tria Tirona

Edwards Comprehensive Cancer Center
Huntington, WV United States
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Geraldine M. Jacobson

West Virginia University Healthcare
Morgantown, WV United States
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Matthew L. Ryan

Saint Vincent Hospital Cancer Center Green Bay
Green Bay, WI United States
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Matthew L. Ryan

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, WI United States
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Collin D. Driscoll

Gundersen Lutheran Medical Center
La Crosse, WI United States
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Carmen R. Bergom

Froedtert and the Medical College of Wisconsin
Milwaukee, WI United States
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Carmen R. Bergom

The Alyce and Elmore Kraemer Cancer Care Center
West Bend, WI United States
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Tien Phan

Tom Baker Cancer Centre
Calgary, AB Canada
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Zsolt Gabos

Cross Cancer Institute
Edmonton, AB Canada
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London Regional Cancer Program
London, ON Canada
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Jean-Michel Caudrelier

Ottawa Hospital and Cancer Center-General Campus
Ottawa, ON Canada
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Giuseppina L. Masucci

CHUM - Hopital Notre-Dame
Montreal, QC Canada
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Tarek Hijal

McGill University Department of Oncology
Montreal, QC Canada
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CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, QC Canada
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Tarek Hijal

The Research Institute of the McGill University Health Centre (MUHC)
Montreal, QC Canada
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Jewish General Hospital
Montreal, QC Canada
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Noha T. Jastaniyah

King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia
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Megan E. Daly

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, CA United States
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UCHealth Memorial Hospital Central
Colorado Springs, CO United States
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Gregory A. Masters

Helen F Graham Cancer Center
Newark, DE United States
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Josh D. Simmons

Lewis Hall Singletary Oncology Center
Thomasville, GA United States
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Steven J. Chmura

University of Chicago Comprehensive Cancer Center
Chicago, IL United States
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Matthew S. Katz

Lowell General Hospital
Lowell, MA United States
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Paul W. Sperduto

Mercy Hospital
Coon Rapids, MN United States
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Benjamin T. Marchello

Kalispell Regional Medical Center
Kalispell, MT United States
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Arul Mahadevan

Wentworth-Douglass Hospital
Dover, NH United States
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Gregory N. Gan

Lovelace Medical Center-Saint Joseph Square
Albuquerque, NM United States
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Lovelace Radiation Oncology
Albuquerque, NM United States
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Achilles J. Fakiris

Rex Cancer Center of Wakefield
Raleigh, NC United States
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Mitchel L. Fromm

Cleveland Clinic Akron General
Akron, OH United States
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Steven W. Corso

Gibbs Cancer Center-Pelham
Greer, SC United States
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Yong Bae Kim

Yonsei University Health System-Severance Hospital
Seoul, Korea, Republic of
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Oleg I. Krijanovski

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, CA United States
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Mitchell R. Kamrava

Cedars Sinai Medical Center
Los Angeles, CA United States
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Kimberly S. Corbin

Mayo Clinic in Florida
Jacksonville, FL United States
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Bryan A. Faller

Southwest Illinois Health Services LLP
Swansea, IL United States
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Frank A. Vicini

21st Century Oncology MHP - Clarkston
Clarkston, MI United States
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Frank A. Vicini

21st Century Oncology MHP - Farmington
Farmington Hills, MI United States
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Frank A. Vicini

21st Century Oncology MHP - Troy
Troy, MI United States
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Paul W. Sperduto

Regions Hospital
Saint Paul, MN United States
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Gregory N. Gan

Christus Saint Vincent Regional Cancer Center
Santa Fe, NM United States
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Andrew Y. Kee

Legacy Good Samaritan Hospital and Medical Center
Portland, OR United States
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Benjamin B. Bridges

Providence Portland Medical Center
Portland, OR United States
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