Radiation Therapy, Paclitaxel, and Carboplatin with or without Trastuzumab in Treating Patients with Esophageal Cancer

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Tissue collection/Repository, Treatment18 and overRTOG 1010
NCI-2011-02601, CDR0000683717, NCT01196390

Trial Description

Summary

This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may block tumor growth by targeting certain tumor cells and causing them to die. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.

Further Study Information

PRIMARY OBJECTIVES:

l. To determine if trastuzumab increases disease-free survival when combined with trimodality treatment (radiation plus chemotherapy followed by surgery) for patients with human epidermal growth factor receptor 2 (HER2)-overexpressing esophageal adenocarcinoma.

SECONDARY OBJECTIVES:

I. To evaluate if the addition of trastuzumab to trimodality treatment increases the pathologic complete response rate and overall survival for patients with HER2-overexpressing esophageal adenocarcinoma.

II. To develop a tissue bank of tumor tissue from patients with non-metastatic esophageal adenocarcinoma.

III. To determine molecular correlates of complete pathologic response, disease-free survival, and overall survival for patients with HER2-overexpressing esophageal adenocarcinoma treated with neoadjuvant and maintenance trastuzumab.

IV. To evaluate predictors of cardiotoxicity in patients with esophageal cancer treated with trastuzumab and chemoradiation.

V. To evaluate adverse events associated with the addition of trastuzumab to trimodality treatment for patients with non-metastatic esophageal adenocarcinoma.

TERTIARY OBJECTIVES:

I. To determine if the addition of trastuzumab to trimodality treatment improves the patient-reported Functional Assessment of Cancer Therapy for Esophageal Cancer (FACT-E) Esophageal Cancer Subscale (ECS) score.

II. To determine if an improvement in the FACT-E ECS score at 6-8 weeks post completion of neoadjuvant chemoradiation correlates with pathologic complete response.

III. To determine if pathologic complete response correlates with the FACT-E ECS score at 1 year and/or 2 years from the start of chemoradiation.

IV. To determine if the addition of trastuzumab to trimodality treatment improves the Swallow Index and Eating Index Subscale scores of the FACT-E.

V. To determine if the addition of trastuzumab to paclitaxel, carboplatin, and radiation impacts quality-adjusted survival.

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

ARM I: Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel intravenously (IV) over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36, and trastuzumab IV over 30-90 minutes on days 1, 8, 15, 22, 29, 36, and 57. Beginning 21-56 days after surgery, patients receive trastuzumab IV over 30-90 minutes. Treatment repeats every 21 days for 13 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Patients also receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36.

Within 5-8 weeks after completion of radiotherapy, all patients undergo surgery.

After completion of study therapy, patients are followed up every 4 months for 2 years and then yearly thereafter.

Eligibility Criteria

Inclusion Criteria:

Pathologically confirmed primary adenocarcinoma of the esophagus that involves the mid (up to 25 cm), distal, or esophagogastric junction; the cancer may involve the stomach up to 5 cm

PRIOR TO STEP 1 REGISTRATION BUT WITHIN 56 DAYS PRIOR TO STEP 2 REGISTRATION

Platelets >=100,000 cells/mm³

HER2 expressing adenocarcinoma of the esophagus centrally

Surgical consultation to confirm that patient will be able to undergo curative resection after completion of chemoradiation within 56 days prior to step 2 registration

Zubrod performance status 0-2 within 14 days prior to step 2 registration

Radiation oncology consultation to confirm that disease can be encompassed in a radiotherapy field within 56 days prior to step 2 registration

Consultation with a medical oncologist within 56 days prior to step 2 registration

Endoscopy with biopsy

Intent to submit tissue for central HER2 testing

For women of childbearing potential, a negative serum pregnancy test within 14 days prior to step 2 registration

Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by cardiac echocardiogram (echo) or multi gated acquisition (MUGA) scan within 56 days prior to step 2 registration

Absolute neutrophil count (ANC) >= 1,500 cells/mm³

Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)

Creatinine =< 2 times upper limit of normal

Zubrod performance status 0-2

Stage T1N1-2, T2-3N0-2, according to the American Joint Committee on Cancer (AJCC) 7th edition staging, based on the following minimum diagnostic work-up:

Chest/abdominal/pelvic computed tomography (CT) or whole-body positron emission tomography (PET)/CT (NOTE: if CT is performed at this time point, whole-body PET/CT will be required prior to step 2 registration; PET/CT of skull base to mid-thigh is acceptable) (NOTE: if adenopathy is noted on CT or whole-body PET/CT scan, an endoscopic ultrasound is not required prior to STEP 2 registration as long as adequate tissue has been obtained for central HER2 testing)

Patients may have regional adenopathy including para-esophageal, gastric, gastrohepatic and celiac nodes; if celiac adenopathy is present, it must be =< 2 cm

Patients with tumors at the level of the carina or above must undergo bronchoscopy to exclude fistula

Women of childbearing potential and sexually active male participants must agree to practice adequate contraception while on study and for at least 60 days following the last dose of chemotherapy or trastuzumab

Bilirubin =< 1.5 times upper limit of normal

Aspartate aminotransferase (AST) =< 3.0 times upper limit of normal

For women of childbearing potential, a negative serum or urine pregnancy test

Patients must sign a study-specific informed consent prior to study entry

CONDITIONS FOR PATIENT ELIGIBILITY PRIOR TO STEP 2 REGISTRATION (HER2-POSITIVE PATIENTS ONLY)

Stage T1N1-2, T2-3N0-2, according to the AJCC 7th edition staging, based upon the following minimum diagnostic work-up:

History/physical examination, with documentation of the patient’s weight, within 14 days prior to step 2 registration

Whole-body PET/CT scan within 56 days prior to step 2 registration (if only CT performed prior to step 1 registration)

Endoscopic ultrasound within 56 days prior to step 2 registration, unless the patient is found to have adenopathy per CT or whole-body PET/CT scan

Electrocardiogram (EKG) within 56 days prior to step 2 registration

Serum creatinine =< 2 x the upper limit or normal within 14 days prior to step 2 registration

Exclusion Criteria:

Severe, active comorbidity, defined as follows:

Unstable angina in the last 6 months

Transmural myocardial infarction within the last 6 months

Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immunocompromised patients

Medical contraindications to esophagectomy

Prior therapy with trastuzumab

Patients with cervical esophageal carcinoma

Patients with T1N0 disease, T4 disease, and proximal esophageal cancers (15-24 cm)

Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable

Prior allergic reaction to the study drugs involved in this protocol or to a monoclonal antibody

Previous history of congestive heart failure

Pregnant or nursing women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Prior radiation therapy for esophageal cancer or prior chest radiotherapy

Prior anthracycline or taxane

Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi

Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are permissible)

Prior therapy with any agent targeting the HER2 pathway or human epidermal growth factor receptor 1 (HER1) (epidermal growth factor receptor [EGFR]) pathway

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Howard Safran, Principal Investigator

Trial Sites

U.S.A.

California
Burlingame

Mills - Peninsula Hospitals

Christopher Uwe Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Christopher Uwe Jones
Principal Investigator

Chico

Enloe Medical Center

Grace E. Yuh
Ph: 530-332-3808

Grace E. Yuh
Principal Investigator

Duarte

City of Hope Comprehensive Cancer Center

Joseph Chao
Ph: 800-826-4673
Email: becomingapatient@coh.org

Joseph Chao
Principal Investigator

Fresno

Fresno Cancer Center

Samantha Andrews Seaward
Ph: 626-564-3455

Samantha Andrews Seaward
Principal Investigator

Greenbrae

Marin General Hospital

Lloyd T. Miyawaki
Ph: 415-925-7325

Lloyd T. Miyawaki
Principal Investigator

Los Angeles

Cedars-Sinai Medical Center

Richard Tuli
Ph: 310-423-8965

Richard Tuli
Principal Investigator

Los Angeles County-USC Medical Center

Heinz-Josef Lenz
Ph: 323-865-0451

Heinz-Josef Lenz
Principal Investigator

USC / Norris Comprehensive Cancer Center

Heinz-Josef Lenz
Ph: 323-865-0451

Heinz-Josef Lenz
Principal Investigator

Modesto

Memorial Medical Center

Christopher Uwe Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Christopher Uwe Jones
Principal Investigator

Oakland

Kaiser Permanente Oakland-Broadway

Samantha Andrews Seaward
Ph: 626-564-3455

Samantha Andrews Seaward
Principal Investigator

Orange

UC Irvine Health/Chao Family Comprehensive Cancer Center

Chaitali S. Nangia
Ph: 877-827-8839
Email: ucstudy@uci.edu

Chaitali S. Nangia
Principal Investigator

Palo Alto

Stanford Cancer Institute

Daniel T. Chang
Ph: 650-498-7061
Email: ccto-office@stanford.edu

Daniel T. Chang
Principal Investigator

Rancho Cordova

Kaiser Permanente-Rancho Cordova Cancer Center

Samantha Andrews Seaward
Ph: 626-564-3455

Samantha Andrews Seaward
Principal Investigator

Rohnert Park

Rohnert Park Cancer Center

Samantha Andrews Seaward
Ph: 626-564-3455

Samantha Andrews Seaward
Principal Investigator

Roseville

Sutter Cancer Centers Radiation Oncology Services-Roseville

Christopher Uwe Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Christopher Uwe Jones
Principal Investigator

The Permanente Medical Group-Roseville Radiation Oncology

Samantha Andrews Seaward
Ph: 626-564-3455

Samantha Andrews Seaward
Principal Investigator

Sacramento

South Sacramento Cancer Center

Samantha Andrews Seaward
Ph: 626-564-3455

Samantha Andrews Seaward
Principal Investigator

Sutter General Hospital

Christopher Uwe Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Christopher Uwe Jones
Principal Investigator

Saint Helena

Saint Helena Hospital

David John Tate
Ph: 707-967-3698

David John Tate
Principal Investigator

Santa Clara

Kaiser Permanente Medical Center - Santa Clara

Samantha Andrews Seaward
Ph: 626-564-3455

Samantha Andrews Seaward
Principal Investigator

South San Francisco

Kaiser Permanente Cancer Treatment Center

Samantha Andrews Seaward
Ph: 626-564-3455

Samantha Andrews Seaward
Principal Investigator

Vallejo

Sutter Solano Medical Center/Cancer Center

Christopher Uwe Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Christopher Uwe Jones
Principal Investigator

Colorado
Aurora

Rocky Mountain Cancer Centers-Aurora

Eduardo R. Pajon
Ph: 888-336-8262

Eduardo R. Pajon
Principal Investigator

Boulder

Rocky Mountain Cancer Centers-Boulder

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Colorado Springs

Penrose-Saint Francis Healthcare

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Denver

Porter Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Englewood

Swedish Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Fort Collins

Poudre Valley Hospital

Joshua Henry Petit
Ph: 970-482-3328

Joshua Henry Petit
Principal Investigator

Greeley

North Colorado Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Longmont

Longmont United Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Loveland

McKee Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Parker

Parker Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Thornton

Rocky Mountain Cancer Centers-Thornton

Eduardo R. Pajon
Ph: 888-336-8262

Eduardo R. Pajon
Principal Investigator

Wheat Ridge

Exempla Lutheran Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Connecticut
Hartford

Hartford Hospital

Andrew L. Salner
Ph: 860-545-5363

Andrew L. Salner
Principal Investigator

Saint Francis Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Meriden

Midstate Medical Center

Andrew L. Salner
Ph: 860-545-5363

Andrew L. Salner
Principal Investigator

Middletown

Middlesex Hospital

Susanna Hong
Ph: 860-358-2058

Susanna Hong
Principal Investigator

New Haven

Yale University

Kimberly Lauren Johung
Ph: 203-785-5702

Kimberly Lauren Johung
Principal Investigator

Delaware
Newark

Christiana Care Health System-Christiana Hospital

Adam Raben
Ph: 302-733-6227

Adam Raben
Principal Investigator

Helen F Graham Cancer Center

Adam Raben
Ph: 302-733-6227

Adam Raben
Principal Investigator

Florida
Stuart

Robert and Carol Weissman Cancer Center at Martin Health

Guillermo Abesada-Terk
Ph: 772-288-5858ext4

Guillermo Abesada-Terk
Principal Investigator

Georgia
Atlanta

Piedmont Hospital

Adam Wayne Nowlan
Ph: 404-425-7943
Email: ORS@piedmont.org

Adam Wayne Nowlan
Principal Investigator

Gainesville

Northeast Georgia Medical Center

Frank Greer Lake
Ph: 770-219-8800
Email: cancerpatient.navigator@nghs.com

Frank Greer Lake
Principal Investigator

Savannah

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

John A. Pablo
Ph: 800-622-6877

John A. Pablo
Principal Investigator

Memorial University Medical Center

Aaron Watson Pederson
Ph: 912-350-8568

Aaron Watson Pederson
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Illinois
Arlington Heights

Northwest Community Hospital

Stephen Schaeffer Nigh
Ph: 847-618-4968

Stephen Schaeffer Nigh
Principal Investigator

Chicago

University of Illinois

Neeta Kiran Venepalli
Ph: 312-355-3046

Neeta Kiran Venepalli
Principal Investigator

Weiss Memorial Hospital

Stuart A. Krauss
Ph: 773-564-5044

Stuart A. Krauss
Principal Investigator

Decatur

Decatur Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Harvey

Ingalls Memorial Hospital

Sulochana D. Yalavarthi
Ph: 708-915-4673
Email: clinicaltrials@ingalls.org

Sulochana D. Yalavarthi
Principal Investigator

Maywood

Loyola University Medical Center

William Small
Ph: 708-226-4357

William Small
Principal Investigator

Rockford

SwedishAmerican Regional Cancer Center/ACT

Harvey E. Einhorn
Ph: 779-696-9400
Email: cancercare@swedishamerican.org

Harvey E. Einhorn
Principal Investigator

Springfield

Memorial Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Indiana
Elkhart

Michiana Hematology Oncology PC-Elkhart

Binh Nguyen Tran
Ph: 574-237-1328

Binh Nguyen Tran
Principal Investigator

Fort Wayne

Parkview Hospital Randallia

Brian K. Chang
Ph: 260-373-8888
Email: parkviewresearch@parkview.com

Brian K. Chang
Principal Investigator

Radiation Oncology Associates PC

Brian K. Chang
Ph: 260-373-8888
Email: parkviewresearch@parkview.com

Brian K. Chang
Principal Investigator

Indianapolis

Franciscan Saint Francis Health-Indianapolis

Stephen Eric Rubenstein
Ph: 317-851-2555

Stephen Eric Rubenstein
Principal Investigator

Mishawaka

Michiana Hematology Oncology PC-Mishawaka

David Alan Hornback
Ph: 800-284-7370

David Alan Hornback
Principal Investigator

Muncie

IU Health Ball Memorial Hospital

Yunjie Xie Lin
Ph: 765-751-5850

Yunjie Xie Lin
Principal Investigator

South Bend

Memorial Hospital of South Bend

David Alan Hornback
Ph: 800-284-7370

David Alan Hornback
Principal Investigator

Iowa
Ames

McFarland Clinic PC-William R Bliss Cancer Center

Joseph James Merchant
Ph: 515-239-2621

Joseph James Merchant
Principal Investigator

Clive

Mercy Cancer Center-West Lakes

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Des Moines

Iowa Methodist Medical Center

Robert J. Behrens
Ph: 515-282-2921

Robert J. Behrens
Principal Investigator

Mercy Medical Center - Des Moines

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Mark Charles Smith
Ph: 800-237-1225

Mark Charles Smith
Principal Investigator

Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088

Donald B. Wender
Principal Investigator

Kansas
Kansas City

University of Kansas Cancer Center

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Overland Park

Kansas City Cancer Centers-Southwest

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Salina

Salina Regional Health Center

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Louisiana
New Orleans

Ochsner Medical Center Jefferson

Jyotsna Fuloria
Ph: 888-562-4763

Jyotsna Fuloria
Principal Investigator

Maine
Scarborough

Maine Medical Center- Scarborough Campus

Ian Jared Bristol
Ph: 207-396-8090
Email: wrighd@mmc.org

Ian Jared Bristol
Principal Investigator

Maryland
Baltimore

Greater Baltimore Medical Center

Marshall A. Levine
Ph: 443-849-3706

Marshall A. Levine
Principal Investigator

University of Maryland/Greenebaum Cancer Center

Mohan Suntharalingam
Ph: 800-888-8823

Mohan Suntharalingam
Principal Investigator

Bel Air

Upper Chesapeake Medical Center

Mohan Suntharalingam
Ph: 800-888-8823

Mohan Suntharalingam
Principal Investigator

Salisbury

Peninsula Regional Medical Center

John Romeo Mansueti
Ph: 866-922-6237

John Romeo Mansueti
Principal Investigator

Massachusetts
Boston

Boston Medical Center

Lisa A. Kachnic
Ph: 617-638-8265

Lisa A. Kachnic
Principal Investigator

Burlington

Lahey Hospital and Medical Center

Asa Joel Nixon
Ph: 781-744-8027

Asa Joel Nixon
Principal Investigator

Pittsfield

Berkshire Hematology Oncology PC

Harvey Zimbler
Ph: 413-496-8205
Email: ggero@bhs1.org

Harvey Zimbler
Principal Investigator

Springfield

Baystate Medical Center

Seth A. Kaufman
Ph: 413-794-9338

Seth A. Kaufman
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

University of Michigan Comprehensive Cancer Center

Howard Safran
Ph: 401-793-2224
Email: hsafran@lifespan.org

Howard Safran
Principal Investigator

Detroit

Henry Ford Hospital

Eleanor M. Walker
Ph: 313-916-1784

Eleanor M. Walker
Principal Investigator

Saint John Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Flint

Genesys Hurley Cancer Institute

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Kalamazoo

West Michigan Cancer Center

Sunil Nagpal
Ph: 269-373-7458

Sunil Nagpal
Principal Investigator

Livonia

Saint Mary Mercy Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Pontiac

Saint Joseph Mercy Oakland

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Southfield

Providence Hospital

Michael J. Kraut
Ph: 248-849-5337
Email: jaswinder.grewal@stjohn.org

Michael J. Kraut
Principal Investigator

Warren

Saint John Macomb-Oakland Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Minnesota
Coon Rapids

Mercy Hospital

Paul W. Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Paul W. Sperduto
Principal Investigator

Duluth

Miller-Dwan Hospital

Bret E.B. Friday
Ph: 888-203-7267

Bret E.B. Friday
Principal Investigator

Edina

Fairview-Southdale Hospital

Paul W. Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Paul W. Sperduto
Principal Investigator

Fridley

Unity Hospital

Paul W. Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Paul W. Sperduto
Principal Investigator

Maplewood

Minnesota Oncology Hematology PA-Maplewood

Paul W. Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Paul W. Sperduto
Principal Investigator

Minneapolis

Abbott-Northwestern Hospital

Paul W. Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Paul W. Sperduto
Principal Investigator

Robbinsdale

North Memorial Medical Health Center

Paul W. Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Paul W. Sperduto
Principal Investigator

Rochester

Mayo Clinic

Michael G. Haddock
Ph: 507-538-7623

Michael G. Haddock
Principal Investigator

Saint Cloud

Coborn Cancer Center at Saint Cloud Hospital

Barbi L. Kaplan-Frenkel
Ph: 877-229-4907
Email: coborncancercenter@centracare.com

Barbi L. Kaplan-Frenkel
Principal Investigator

Saint Paul

Regions Hospital

Paul W. Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Paul W. Sperduto
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

Pierre Edouard De Delva
Ph: 601-815-6700

Pierre Edouard De Delva
Principal Investigator

Pascagoula

Singing River Hospital

James E. Clarkson
Ph: 228-809-5292

James E. Clarkson
Principal Investigator

Missouri
Cape Girardeau

Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Chesterfield

Saint Luke's Hospital

Donald F. Busiek
Ph: 314-205-6936

Donald F. Busiek
Principal Investigator

Kansas City

Kansas City Cancer Center - South

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Kansas City Cancer Centers - North

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

North Kansas City Hospital

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Lee's Summit

Kansas City Cancer Center-Lee's Summit

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Rolla

Phelps County Regional Medical Center

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Saint Louis

Mercy Hospital Saint Louis

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Missouri Baptist Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Saint Anthony's Medical Center

Minxiang (Michael) Gu
Ph: 888-823-5923
Email: ctsucontact@westat.com

Minxiang (Michael) Gu
Principal Investigator

Washington University School of Medicine

Clifford G Robinson
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Clifford G Robinson
Principal Investigator

Springfield

CoxHealth South Hospital

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Mercy Hospital Springfield

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Montana
Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Bozeman

Bozeman Deaconess Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Nebraska
Grand Island

CHI Health Saint Francis

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Kearney

CHI Health Good Samaritan

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Omaha

Alegent Health Bergan Mercy Medical Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Nebraska Methodist Hospital

Tien-Shew William Huang
Ph: 402-354-5144

Tien-Shew William Huang
Principal Investigator

Nevada
Henderson

Comprehensive Cancer Centers of Nevada - Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas

Comprehensive Cancer Centers of Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Central Valley

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Northwest

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Summerlin

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Central

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Reno

Renown Regional Medical Center

Michael Chandler Hardacre
Ph: 775-982-4400

Michael Chandler Hardacre
Principal Investigator

New Hampshire
Concord

Concord Hospital

Su K. Metcalfe
Ph: 800-441-1138

Su K. Metcalfe
Principal Investigator

Dover

Wentworth-Douglass Hospital

Taylor M. Ortiz
Ph: 603-740-2150

Taylor M. Ortiz
Principal Investigator

Lebanon

Dartmouth Hitchcock Medical Center

Bassem Isaac Zaki
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Bassem Isaac Zaki
Principal Investigator

New Jersey
Basking Ridge

Memorial Sloan Kettering Cancer Center at Basking Ridge

Abraham Jing-Ching Wu
Ph: 212-639-7202

Abraham Jing-Ching Wu
Principal Investigator

Camden

Cooper Hospital University Medical Center

Sucha Order Asbell
Ph: 856-325-6757

Sucha Order Asbell
Principal Investigator

Morristown

Morristown Medical Center

Mona Karim
Ph: 973-971-5900

Mona Karim
Principal Investigator

Mount Holly

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Lemuel S. Ariaratnam
Ph: 888-847-8823

Lemuel S. Ariaratnam
Principal Investigator

Newark

UMDNJ - New Jersey Medical School

Sabin Bhagwan Motwani
Ph: 732-235-8675

Sabin Bhagwan Motwani
Principal Investigator

Pennington

Capital Health Medical Center-Hopewell

Shirnett Karean Williamson
Ph: 800-255-3440

Shirnett Karean Williamson
Principal Investigator

Sparta

Sparta Cancer Treatment Center

Voichita Bar Ad
Ph: 215-955-6084

Voichita Bar Ad
Principal Investigator

Voorhees

MD Anderson Cancer Center at Cooper-Voorhees

Sucha Order Asbell
Ph: 856-325-6757

Sucha Order Asbell
Principal Investigator

New Mexico
Albuquerque

University of New Mexico

Howard Safran
Ph: 401-793-2224
Email: hsafran@lifespan.org

Howard Safran
Principal Investigator

University of New Mexico Cancer Center

Fa-Chyi Lee
Ph: 505-272-6972

Fa-Chyi Lee
Principal Investigator

New York
Bronx

Montefiore Medical Center - Moses Campus

Lakshmi Rajdev
Ph: 718-904-2730
Email: aecc@aecom.yu.edu

Lakshmi Rajdev
Principal Investigator

Commack

Memorial Sloan Kettering Cancer Center Commack

Abraham Jing-Ching Wu
Ph: 212-639-7202

Abraham Jing-Ching Wu
Principal Investigator

New York

Columbia University Medical Center

Naiyer Abbas Rizvi
Ph: 212-305-8615

Naiyer Abbas Rizvi
Principal Investigator

Memorial Sloan-Kettering Cancer Center

Abraham Jing-Ching Wu
Ph: 212-639-7202

Abraham Jing-Ching Wu
Principal Investigator

Rochester

Highland Hospital

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

University of Rochester

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

Rockville Centre

Memorial Sloan-Kettering Cancer Center Rockville Centre

Abraham Jing-Ching Wu
Ph: 212-639-7202

Abraham Jing-Ching Wu
Principal Investigator

Sleepy Hollow

Memorial Sloan-Kettering Cancer Center Sleepy Hollow

Abraham Jing-Ching Wu
Ph: 212-639-7202

Abraham Jing-Ching Wu
Principal Investigator

North Carolina
Charlotte

Carolinas Medical Center/Levine Cancer Institute

Jonathan C. Salo
Ph: 704-355-2884

Jonathan C. Salo
Principal Investigator

Novant Health Presbyterian Medical Center

Justin Peter Favaro
Ph: 704-384-5369

Justin Peter Favaro
Principal Investigator

Concord

Carolinas HealthCare System NorthEast

Jonathan C. Salo
Ph: 704-355-2884

Jonathan C. Salo
Principal Investigator

Kinston

Kinston Medical Specialists PA

Peter Robins Watson
Ph: 252-559-2200

Peter Robins Watson
Principal Investigator

Monroe

Carolinas HealthCare System Union

Jonathan C. Salo
Ph: 704-355-2884

Jonathan C. Salo
Principal Investigator

Raleigh

Rex Cancer Center

Oludamilola Abidemi Olajide
Ph: 919-784-7209

Oludamilola Abidemi Olajide
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Arthur William Blackstock
Ph: 336-713-6771

Arthur William Blackstock
Principal Investigator

North Dakota
Minot

Trinity Cancer Care Center

Kevin B. Collins
Ph: 888-823-5923
Email: ctsucontact@westat.com

Kevin B. Collins
Principal Investigator

Ohio
Akron

Summa Akron City Hospital/Cooper Cancer Center

Charles Andrew Kunos
Ph: 330-375-6101

Charles Andrew Kunos
Principal Investigator

Barberton

Summa Barberton Hospital

Charles Andrew Kunos
Ph: 330-375-6101

Charles Andrew Kunos
Principal Investigator

Beachwood

UHHS-Chagrin Highlands Medical Center

Jennifer Anne Dorth
Ph: 800-641-2422

Jennifer Anne Dorth
Principal Investigator

Chardon

Geaugra Hospital

Jennifer Anne Dorth
Ph: 800-641-2422

Jennifer Anne Dorth
Principal Investigator

Cincinnati

University of Cincinnati

Kevin Patrick Redmond
Ph: 513-558-4553
Email: uchealthnews@uc.edu

Kevin Patrick Redmond
Principal Investigator

Cleveland

Case Western Reserve University

Jennifer Anne Dorth
Ph: 800-641-2422

Jennifer Anne Dorth
Principal Investigator

MetroHealth Medical Center

Bruce J. Averbook
Ph: 216-778-8526
Email: kbauchens@metrohealth.org

Bruce J. Averbook
Principal Investigator

Columbus

Ohio State University Comprehensive Cancer Center

Howard Safran
Ph: 401-793-2224
Email: hsafran@lifespan.org

Howard Safran
Principal Investigator

The Mark H Zangmeister Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Dayton

Good Samaritan Hospital - Dayton

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Miami Valley Hospital

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Elyria

Mercy Cancer Center-Elyria

Jennifer Anne Dorth
Ph: 800-641-2422

Jennifer Anne Dorth
Principal Investigator

Greenville

Wayne Hospital

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Kettering

Kettering Medical Center

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

Medina

Summa Health Center at Lake Medina

Charles Andrew Kunos
Ph: 330-375-6101

Charles Andrew Kunos
Principal Investigator

Mentor

Lake University Ireland Cancer Center

Jennifer Anne Dorth
Ph: 800-641-2422

Jennifer Anne Dorth
Principal Investigator

Middleburg Heights

Southwest General Health Center Ireland Cancer Center

Jennifer Anne Dorth
Ph: 800-641-2422

Jennifer Anne Dorth
Principal Investigator

Oregon

Saint Charles Hospital

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Parma

University Hospitals Parma Medical Center

Jennifer Anne Dorth
Ph: 800-641-2422

Jennifer Anne Dorth
Principal Investigator

Portsmouth

Southern Ohio Medical Center

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Sylvania

Flower Hospital

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Toledo

Mercy Saint Anne Hospital

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Troy

Upper Valley Medical Center

Howard M. Gross
Ph: 937-775-1350

Howard M. Gross
Principal Investigator

West Chester

University Pointe

Kevin Patrick Redmond
Ph: 513-558-4553
Email: uchealthnews@uc.edu

Kevin Patrick Redmond
Principal Investigator

Westlake

UHHS-Westlake Medical Center

Jennifer Anne Dorth
Ph: 800-641-2422

Jennifer Anne Dorth
Principal Investigator

Zanesville

Genesis HealthCare System

John Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

John Philip Kuebler
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Terence S. Herman
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Terence S. Herman
Principal Investigator

Oregon
Clackamas

Clackamas Radiation Oncology Center

Matthew C. Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Matthew C. Solhjem
Principal Investigator

Portland

Providence Portland Medical Center

Matthew C. Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Matthew C. Solhjem
Principal Investigator

Providence Saint Vincent Medical Center

Matthew C. Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Matthew C. Solhjem
Principal Investigator

Salem

Salem Hospital

John Strother
Ph: 503-561-2618

John Strother
Principal Investigator

Pennsylvania
Bryn Mawr

Bryn Mawr Hospital

Albert S. DeNittis
Ph: 866-225-5654

Albert S. DeNittis
Principal Investigator

Danville

Geisinger Medical Center

Thomas James Gergel
Ph: 570-271-5251

Thomas James Gergel
Principal Investigator

Drexel Hill

Delaware County Memorial Hospital

Rachelle M. Lanciano
Ph: 610-284-8237
Email: jolene.garney@crozer.org

Rachelle M. Lanciano
Principal Investigator

Dunmore

Northeast Radiation Oncology Center

Voichita Bar Ad
Ph: 215-955-6084

Voichita Bar Ad
Principal Investigator

Paoli

Paoli Memorial Hospital

Albert S. DeNittis
Ph: 866-225-5654

Albert S. DeNittis
Principal Investigator

Philadelphia

American College of Radiology Imaging Network

Howard Safran
Email: hsafran@lifespan.org

Howard Safran
Principal Investigator

Aria Health-Torresdale Campus

Voichita Bar Ad
Ph: 215-955-6084

Voichita Bar Ad
Principal Investigator

Fox Chase Cancer Center

Joshua E. Meyer
Ph: 215-728-4790

Joshua E. Meyer
Principal Investigator

Pittsburgh

UPMC-Shadyside Hospital

Dwight Earl Heron
Ph: 412-647-8073

Dwight Earl Heron
Principal Investigator

West Reading

Reading Hospital

Albert Yuen
Ph: 610-988-9323

Albert Yuen
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Thomas James Gergel
Ph: 570-271-5251

Thomas James Gergel
Principal Investigator

Wynnewood

Lankenau Medical Center

Albert S. DeNittis
Ph: 866-225-5654

Albert S. DeNittis
Principal Investigator

Rhode Island
Providence

Radiation Oncology Associates Incorporated

Howard Safran
Ph: 401-444-1488

Howard Safran
Principal Investigator

Rhode Island Hospital

Howard Safran
Ph: 401-444-1488

Howard Safran
Principal Investigator

South Carolina
Anderson

AnMed Health Cancer Center

John Eric Doster
Ph: 864-512-1000

John Eric Doster
Principal Investigator

Charleston

Medical University of South Carolina

Steve H. Chin
Ph: 843-792-9321

Steve H. Chin
Principal Investigator

Greenville

Greenville Health System Cancer Institute-Andrews

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Eastside

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Faris

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greer

Greenville Health System Cancer Institute-Greer

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Seneca

Greenville Health System Cancer Institute-Seneca

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Spartanburg

Greenville Health System Cancer Institute-Spartanburg

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Texas
Galveston

University of Texas Medical Branch

Todd Allen Swanson
Ph: 409-772-1950
Email: clinical.research@utmb.edu

Todd Allen Swanson
Principal Investigator

League City

UTMB Cancer Center at Victory Lakes

Todd Allen Swanson
Ph: 409-772-1950
Email: clinical.research@utmb.edu

Todd Allen Swanson
Principal Investigator

Lubbock

Covenant Medical Center-Lakeside

Paul J. Anderson
Ph: 806-725-8000
Email: jaccresearch@covhs.org

Paul J. Anderson
Principal Investigator

Utah
Murray

Intermountain Medical Center

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Saint George

Dixie Medical Center Regional Cancer Center

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Salt Lake City

Utah Cancer Specialists-Salt Lake City

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Vermont
Saint Johnsbury

Norris Cotton Cancer Center-North

Bassem Isaac Zaki
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Bassem Isaac Zaki
Principal Investigator

Washington
Bellingham

PeaceHealth Saint Joseph Medical Center

Michael Andre Taylor
Ph: 360-788-8223
Email: cpatz@peacehealth.org

Michael Andre Taylor
Principal Investigator

Bremerton

Harrison Medical Center

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Longview

Saint John Medical Center

Matthew C. Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Matthew C. Solhjem
Principal Investigator

Mount Vernon

Skagit Valley Hospital

George E. Laramore
Ph: 206-616-8289

George E. Laramore
Principal Investigator

Seattle

Seattle Cancer Care Alliance

George E. Laramore
Ph: 206-616-8289

George E. Laramore
Principal Investigator

Swedish Medical Center-First Hill

Gary E. Goodman
Ph: 206-386-2323
Email: patra.grevstad@swedish.org

Gary E. Goodman
Principal Investigator

Vancouver

PeaceHealth Southwest Medical Center

Matthew C. Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Matthew C. Solhjem
Principal Investigator

West Virginia
Charleston

West Virginia University Charleston

Steven James Jubelirer
Ph: 304-344-3457

Steven James Jubelirer
Principal Investigator

Wheeling

Wheeling Hospital/Schiffler Cancer Center

Jondavid Pollock
Ph: 304-243-6442

Jondavid Pollock
Principal Investigator

Wisconsin
Eau Claire

Sacred Heart Hospital

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Green Bay

Aurora BayCare Medical Center

Ellen L. Ziaja
Ph: 800-252-2990

Ellen L. Ziaja
Principal Investigator

Saint Mary's Hospital

James L. Leenstra
Ph: 920-433-8889

James L. Leenstra
Principal Investigator

Saint Vincent Hospital

James L. Leenstra
Ph: 920-433-8889

James L. Leenstra
Principal Investigator

La Crosse

Gundersen Lutheran Medical Center

Collin D. Driscoll
Ph: 608-775-2385
Email: cancerctr@gundluth.org

Collin D. Driscoll
Principal Investigator

Marinette

Bay Area Medical Center

James L. Leenstra
Ph: 920-433-8889

James L. Leenstra
Principal Investigator

Vince Lombardi Cancer Clinic-Marinette

Ellen L. Ziaja
Ph: 800-252-2990

Ellen L. Ziaja
Principal Investigator

Marshfield

Saint Joseph's Hospital

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Milwaukee

Aurora Saint Luke's Medical Center

Ellen L. Ziaja
Ph: 800-252-2990

Ellen L. Ziaja
Principal Investigator

Froedtert and the Medical College of Wisconsin

Candice Aitken Johnstone
Ph: 414-805-4380

Candice Aitken Johnstone
Principal Investigator

Zablocki Veterans Administration Medical Center

Elizabeth M. Gore
Ph: 414-805-4380

Elizabeth M. Gore
Principal Investigator

Minocqua

Marshfield Clinic-Minocqua Center

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

New Richmond

Cancer Center of Western Wisconsin

Paul W. Sperduto
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Paul W. Sperduto
Principal Investigator

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Ellen L. Ziaja
Ph: 800-252-2990

Ellen L. Ziaja
Principal Investigator

Rice Lake

Marshfield Clinic-Rice Lake Center

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Stevens Point

Saint Michael's Hospital

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Sturgeon Bay

Door County Cancer Center

James L. Leenstra
Ph: 920-433-8889

James L. Leenstra
Principal Investigator

Summit

Aurora Medical Center in Summit

Ellen L. Ziaja
Ph: 800-252-2990

Ellen L. Ziaja
Principal Investigator

West Bend

The Alyce and Elmore Kraemer Cancer Care Center

Candice Aitken Johnstone
Ph: 414-805-4380

Candice Aitken Johnstone
Principal Investigator

Weston

Diagnostic and Treatment Center

Rezwan Islam
Ph: 715-393-1400

Rezwan Islam
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01196390

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.