Dactinomycin or Methotrexate in Treating Patients with Low-Risk Gestational Trophoblastic Neoplasia

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIITreatment18 and overGOG-0275
NCI-2012-00250, CDR0000725211, PGOG-0275_A08PAMDREVW01, NCT01535053

Trial Description

Summary

This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, 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. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

Further Study Information

PRIMARY OBJECTIVES:

I. To test the hypothesis that treatment with multi-day methotrexate is inferior to treatment with pulse actinomycin-D (dactinomycin) in patients with low-risk gestational trophoblastic disease with respect to complete response.

SECONDARY OBJECTIVES:

I. To describe the frequency of post protocol surgical treatment for each arm.

II. To describe the frequency of post protocol multi-agent chemotherapy treatment for each arm.

III. To compare multi-day methotrexate to actinomycin-D with respect to frequency and severity of adverse events in patients with low-risk gestational trophoblastic neoplasia.

IV. To investigate the impact of treatment on overall quality-of-life (QOL) and explore the influence of treatment on issues such as body image, sexual functioning, and patient-reported side effects and disruption.

V. To assess whether uterine artery pulsatility index (UAPI) can provide independent prognostic information predictive of single-drug resistance.

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

ARM I: Patients receive dactinomycin intravenously (IV) over 15 minutes on day 1.

ARM II: Patients receive methotrexate intramuscularly (IM) on days 1, 3, 5, and 7 and leucovorin calcium orally (PO) on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.

In both arms, treatment repeats every 14 days for up to 20 courses* in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 1 year and then every 3 months for 1 year.

NOTE: * Patients will be treated for three courses after human chorionic gonadotropin (hCG) < 5 mIU/mL or until evidence of treatment failure (biologic progression), disease progression, or unacceptable toxicity despite dose modifications. Upon normalization of hCG (< 5 mIU/mL), patients will be treated with three additional courses.

Eligibility Criteria

Inclusion Criteria:

Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:

Post molar GTN

  • For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:

*** A < 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml minimum) OR

*** A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml minimum) OR

*** A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum)

Choriocarcinoma

  • Histologically proven non-metastatic choriocarcinoma OR
  • Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung

Patients must have signed an approved informed consent and authorization permitting release of personal health information

Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy

Patients who have met the pre-entry requirements

Alkaline phosphatase =< 3 x institutional normal

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x institutional normal

Bilirubin =< 1.5 x institutional normal

Creatinine =< 2.0 mg/dcL

Platelets >= 100,000/mcL

Granulocytes >= 1,500/mcL

White blood cell count (WBC) >= 3,000 cells/mcL

Patients must be willing to practice effective contraception for the duration of the study

World Health Organization (WHO) risk score 0-6

Exclusion Criteria:

Patients who wish to breast-feed during treatment

Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up

Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy

Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4

Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)

Patients who have received prior pelvic radiation

Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study

Patients who do not have GTN

Patients with non-gestational choriocarcinoma

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • National Cancer Institute
Julian C. Schink, Principal Investigator

Trial Sites

U.S.A.

Arizona
Phoenix

Saint Joseph's Hospital and Medical Center

John Hall Farley
Ph: 301-319-2100

John Hall Farley
Principal Investigator

California
La Jolla

UC San Diego Moores Cancer Center

Michael T. McHale
Ph: 858-822-5354
Email: cancercto@ucsd.edu

Michael T. McHale
Principal Investigator

Loma Linda

Loma Linda University Medical Center

Yevgeniya Jane Mikhailovn Ioffe
Ph: 909-558-4050

Yevgeniya Jane Mikhailovn Ioffe
Principal Investigator

Los Angeles

Kaiser Permanente Los Angeles Medical Center

Scott E. Lentz
Ph: 626-564-3455

Scott E. Lentz
Principal Investigator

Georgia
Atlanta

Northside Hospital

Guilherme Henrique C. Cantuaria
Ph: 404-303-3355
Email: clinicaltrials@northside.com

Guilherme Henrique C. Cantuaria
Principal Investigator

Augusta

Georgia Regents University Medical Center

Sharad Anant Ghamande
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

Sharad Anant Ghamande
Principal Investigator

Cumming

Northside Hospital-Forsyth

Guilherme Henrique C. Cantuaria
Ph: 404-303-3355
Email: clinicaltrials@northside.com

Guilherme Henrique C. Cantuaria
Principal Investigator

Decatur

Dekalb Medical Center

Cyril O. Spann
Ph: 404-501-3279

Cyril O. Spann
Principal Investigator

Gainesville

Northeast Georgia Medical Center

Andrew Emmons Green
Ph: 770-219-8800
Email: cancerpatient.navigator@nghs.com

Andrew Emmons Green
Principal Investigator

Savannah

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

William Edward Richards
Ph: 800-622-6877

William Edward Richards
Principal Investigator

Low Country Cancer Care Associates PC

James Joseph Burke
Ph: 912-350-8568

James Joseph Burke
Principal Investigator

Memorial University Medical Center

James Joseph Burke
Ph: 912-350-8568

James Joseph Burke
Principal Investigator

Summit Cancer Care-Memorial

James Joseph Burke
Ph: 912-350-8568

James Joseph Burke
Principal Investigator

Idaho
Coeur D'Alene

Kootenai Medical Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Post Falls

Kootenai Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Sandpoint

Kootenai Cancer

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Illinois
Aurora

Rush - Copley Medical Center

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Principal Investigator

Chicago

Northwestern University

Emily Berry
Ph: 312-695-1301
Email: cancer@northwestern.edu

Emily Berry
Principal Investigator

University of Chicago Comprehensive Cancer Center

Meaghan Elizabeth Tenney
Ph: 773-834-7424

Meaghan Elizabeth Tenney
Principal Investigator

Danville

Carle on Vermilion

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Principal Investigator

Effingham

Carle Physician Group-Effingham

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Principal Investigator

Evanston

NorthShore University HealthSystem-Evanston Hospital

Jean A. Hurteau
Ph: 847-570-2109

Jean A. Hurteau
Principal Investigator

Glenview

NorthShore University HealthSystem-Glenbrook Hospital

Jean A. Hurteau
Ph: 847-570-2109

Jean A. Hurteau
Principal Investigator

Highland Park

NorthShore University HealthSystem-Highland Park Hospital

Jean A. Hurteau
Ph: 847-570-2109

Jean A. Hurteau
Principal Investigator

Hinsdale

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Sudarshan K. Sharma
Ph: 630-856-6757

Sudarshan K. Sharma
Principal Investigator

Mattoon

Carle Physician Group-Mattoon/Charleston

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Principal Investigator

New Lennox

UC Comprehensive Cancer Center at Silver Cross

Meaghan Elizabeth Tenney
Ph: 773-834-7424

Meaghan Elizabeth Tenney
Principal Investigator

Skokie

North Shore Medical Center

Jean A. Hurteau
Ph: 847-570-2109

Jean A. Hurteau
Principal Investigator

Urbana

Carle Cancer Center

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Principal Investigator

The Carle Foundation Hospital

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Principal Investigator

Yorkville

Rush-Copley Healthcare Center

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Principal Investigator

Indiana
Elkhart

Michiana Hematology Oncology PC-Elkhart

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

Indianapolis

Saint Vincent Oncology Center

Michael J. Callahan
Ph: 317-338-2194
Email: research@stvincent.org

Michael J. Callahan
Principal Investigator

Michigan City

Franciscan Saint Anthony Health-Michigan City

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Principal Investigator

Woodland Cancer Care Center

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Principal Investigator

Mishawaka

Michiana Hematology Oncology PC-Mishawaka

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

Saint Joseph Regional Medical Center-Mishawaka

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

Plymouth

Michiana Hematology Oncology PC-Plymouth

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

South Bend

Memorial Hospital of South Bend

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

Michiana Hematology Oncology PC-South Bend

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

Northern Indiana Cancer Research Consortium CCOP

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

Westville

Michiana Hematology Oncology PC-Westville

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

Iowa
Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088

Donald B. Wender
Principal Investigator

Kentucky
Edgewood

Saint Elizabeth Medical Center South

James Clifford Pavelka
Ph: 513-862-2230

James Clifford Pavelka
Principal Investigator

Maine
Scarborough

Maine Medical Center- Scarborough Campus

Christopher J. Darus
Ph: 207-885-7565

Christopher J. Darus
Principal Investigator

Maryland
Bethesda

Walter Reed National Military Medical Center

William J. Lowery
Ph: 301-319-2100

William J. Lowery
Principal Investigator

Massachusetts
Boston

Brigham and Women's Hospital

Neil Stuart Horowitz
Ph: 617-724-5200

Neil Stuart Horowitz
Principal Investigator

Dana-Farber Cancer Institute

Neil Stuart Horowitz
Ph: 617-724-5200

Neil Stuart Horowitz
Principal Investigator

Michigan
Battle Creek

Bronson Battle Creek

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Grand Rapids

Mercy Health Saint Mary's

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Spectrum Health at Butterworth Campus

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Kalamazoo

West Michigan Cancer Center

Sunil Nagpal
Ph: 269-373-7458

Sunil Nagpal
Principal Investigator

Muskegon

Mercy Health Mercy Campus

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Reed City

Spectrum Health Reed City Hospital

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Saint Joseph

Marie Yeager Cancer Center

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

St. Joseph

Lakeland Hospital

Michael W. Method
Ph: 574-237-1328

Michael W. Method
Principal Investigator

Traverse City

Munson Medical Center

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Minnesota
Burnsville

Fairview Ridges Hospital

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Coon Rapids

Mercy Hospital

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Edina

Fairview-Southdale Hospital

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Fridley

Unity Hospital

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Maplewood

Minnesota Oncology Hematology PA-Maplewood

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Saint John's Hospital - Healtheast

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Minneapolis

Abbott-Northwestern Hospital

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Health Partners Inc

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Hennepin County Medical Center

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

New Ulm

New Ulm Medical Center

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Robbinsdale

North Memorial Medical Health Center

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Saint Louis Park

Park Nicollet Clinic - Saint Louis Park

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Saint Paul

Regions Hospital

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

United Hospital

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Shakopee

Saint Francis Regional Medical Center

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Stillwater

Lakeview Hospital

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Waconia

Ridgeview Medical Center

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Willmar

Rice Memorial Hospital

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Woodbury

Minnesota Oncology and Hematology PA-Woodbury

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Missouri
Saint Louis

Washington University School of Medicine

David Gardner Mutch
Ph: 800-600-3606
Email: info@ccadmin.wustl.edu

David Gardner Mutch
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

Montana Cancer Consortium CCOP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Saint Vincent Healthcare

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

Butte

Saint James Community Hospital and Cancer Treatment Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Great Falls

Benefis Healthcare- Sletten Cancer Institute

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Helena

Saint Peter's Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Kalispell

Kalispell Regional Medical Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Missoula

Community Medical Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Saint Patrick Hospital - Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Nevada
Las Vegas

Women's Cancer Center of Nevada

Nicola M. Spirtos
Ph: 702-851-4672

Nicola M. Spirtos
Principal Investigator

New Mexico
Albuquerque

Southwest Gynecologic Oncology Associates Inc

Carolyn Y. Muller
Ph: 505-272-6972

Carolyn Y. Muller
Principal Investigator

University of New Mexico

Carolyn Y. Muller
Ph: 505-272-6972

Carolyn Y. Muller
Principal Investigator

New York
Brooklyn

State University of New York Downstate Medical Center

Ovadia Abulafia
Ph: 718-270-8216
Email: sima.terebelo@downstate.edu

Ovadia Abulafia
Principal Investigator

Ohio
Akron

Summa Akron City Hospital/Cooper Cancer Center

Stephen J. Andrews
Ph: 330-375-6101

Stephen J. Andrews
Principal Investigator

Belpre

Strecker Cancer Center-Belpre

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

John Philip Kuebler
Principal Investigator

Chillicothe

Adena Regional Medical Center

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

John Philip Kuebler
Principal Investigator

Cincinnati

Bethesda North Hospital

James Clifford Pavelka
Ph: 513-862-2230

James Clifford Pavelka
Principal Investigator

Good Samaritan Hospital - Cincinnati

James Clifford Pavelka
Ph: 513-862-2230

James Clifford Pavelka
Principal Investigator

Cleveland

Case Western Reserve University

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
Principal Investigator

Cleveland Clinic Cancer Center/Fairview Hospital

Peter G. Rose
Ph: 866-223-8100

Peter G. Rose
Principal Investigator

Cleveland Clinic Foundation

Peter G. Rose
Ph: 866-223-8100

Peter G. Rose
Principal Investigator

Columbus

Columbus Oncology and Hematology Associates Inc

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

John Philip Kuebler
Principal Investigator

Doctors Hospital

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

John Philip Kuebler
Principal Investigator

Grant Medical Center

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

John Philip Kuebler
Principal Investigator

Mount Carmel Health Center West

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

John Philip Kuebler
Principal Investigator

Ohio State University Comprehensive Cancer Center

David M. O'Malley
Ph: 800-293-5066
Email: Jamesline@osumc.edu

David M. O'Malley
Principal Investigator

Riverside Methodist Hospital

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

John Philip Kuebler
Principal Investigator

The Mark H Zangmeister Center

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

John Philip Kuebler
Principal Investigator

Delaware

Delaware Health Center-Grady Cancer Center

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

John Philip Kuebler
Principal Investigator

Delaware Radiation Oncology

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

John Philip Kuebler
Principal Investigator

Grady Memorial Hospital

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

John Philip Kuebler
Principal Investigator

Lancaster

Fairfield Medical Center

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

John Philip Kuebler
Principal Investigator

Marietta

Marietta Memorial Hospital

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

John Philip Kuebler
Principal Investigator

Mayfield Heights

Hillcrest Hospital Cancer Center

Peter G. Rose
Ph: 866-223-8100

Peter G. Rose
Principal Investigator

Mentor

Lake University Ireland Cancer Center

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
Principal Investigator

Mount Vernon

Knox Community Hospital

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

John Philip Kuebler
Principal Investigator

Newark

Licking Memorial Hospital

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

John Philip Kuebler
Principal Investigator

Newark Radiation Oncology

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

John Philip Kuebler
Principal Investigator

Portsmouth

Southern Ohio Medical Center

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

John Philip Kuebler
Principal Investigator

Westerville

Saint Ann's Hospital

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

John Philip Kuebler
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

Robert S. Mannel
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Robert S. Mannel
Principal Investigator

Tulsa

Tulsa Cancer Institute

Robert S. Mannel
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Robert S. Mannel
Principal Investigator

Pennsylvania
Abington

Abington Memorial Hospital

Parviz Hanjani
Ph: 215-481-2402

Parviz Hanjani
Principal Investigator

Beaver

UPMC-Heritage Valley Health System Beaver

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

Clairton

UPMC Cancer Center at Jefferson Regional Medical Center

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

Danville

Geisinger Medical Center

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Greensburg

UPMC Cancer Centers - Arnold Palmer Pavilion

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

Hazleton

Geisinger Medical Center-Cancer Center Hazleton

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Johnstown

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

McKeesport

UPMC Cancer Center at UPMC McKeesport

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

Moon Township

UPMC-Coraopolis/Heritage Valley Radiation Oncology

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

Pittsburgh

University of Pittsburgh Cancer Institute (UPCI)

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Magee Womens Hospital

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Passavant Hospital

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Presbyterian Hospital

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Saint Clair Hospital Cancer Center

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Saint Margaret

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

UPMC-Shadyside Hospital

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

Seneca

UPMC Cancer Center at UPMC Northwest

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

State College

Geisinger Medical Group

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Uniontown

UPMC Uniontown Hospital Radiation Oncology

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

Washington

UPMC Washington Hospital Radiation Oncology

Alexander Babatunde Olawaiye
Ph: 412-647-2811

Alexander Babatunde Olawaiye
Principal Investigator

West Reading

Reading Hospital

Bernice L. Robinson-Bennett
Ph: 610-988-9323

Bernice L. Robinson-Bennett
Principal Investigator

Wilkes-Barre

Geisinger Wyoming Valley/Henry Cancer Center

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Rhode Island
Providence

Women and Infants Hospital

Carolyn Kay McCourt
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Carolyn Kay McCourt
Principal Investigator

Tennessee
Knoxville

University of Tennessee - Knoxville

Larry Clinton Kilgore
Ph: 865-544-9773

Larry Clinton Kilgore
Principal Investigator

Texas
Austin

University Medical Center Brackenridge

Mark Allen Crozier
Ph: 512-324-7991

Mark Allen Crozier
Principal Investigator

Dallas

Parkland Memorial Hospital

David Scott Miller
Ph: 214-648-7097

David Scott Miller
Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

David Scott Miller
Ph: 214-648-7097

David Scott Miller
Principal Investigator

West Virginia
Morgantown

Monongalia Hospital

Jamie L. Lesnock
Ph: 888-823-5923
Email: ctsucontact@westat.com

Jamie L. Lesnock
Principal Investigator

Wisconsin
Burlington

Aurora Cancer Care-Burlington

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Elkhorn

Aurora Cancer Care-Southern Lakes

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Fond Du Lac

Aurora Health Center-Fond du Lac

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Grafton

Aurora Cancer Care-Grafton

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Green Bay

Aurora BayCare Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Kenosha

Aurora Cancer Care-Kenosha South

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Marinette

Vince Lombardi Cancer Clinic-Marinette

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Menomonee Falls

Aurora Advanced Healthcare Inc-Menomonee Falls

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Milwaukee

Aurora Cancer Care-Milwaukee

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Aurora Cancer Care-Milwaukee South

Ali Mahdavi
Ph: 414-649-5717
Email: ucstudy@uci.edu

Ali Mahdavi
Principal Investigator

Aurora Saint Luke's Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Aurora Sinai Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

New Richmond

Cancer Center of Western Wisconsin

Matthew P. Boente
Ph: 952-993-1517
Email: MMCCOP@parknicollet.com

Matthew P. Boente
Principal Investigator

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Racine

Aurora Cancer Care-Racine

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Sheboygan

Vince Lombardi Cancer Clinic-Sheboygan

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Summit

Aurora Medical Center in Summit

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Two Rivers

Vince Lombardi Cancer Clinic

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Waukesha

Aurora Cancer Care-Waukesha

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Wauwatosa

Aurora Cancer Care-Milwaukee West

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

West Allis

Aurora West Allis Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Wyoming
Cody

Big Horn Basin Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Billings Clinic-Cody

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Sheridan

Welch Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Canada

Ontario
Toronto

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Allan L. Covens
Ph: 416-480-5000

Allan L. Covens
Principal Investigator

Japan

Hiroshima City

Hiroshima University Hospital

Yoshiki Kudo
Ph: 82-424-6042

Yoshiki Kudo
Principal Investigator

Kagoshima City

Kagoshima City Hospital

Toshiaki Nakamura
Ph: 011 81 099 224 2101

Toshiaki Nakamura
Principal Investigator

Kure

Kure National Hospital

Takashi Sawasaki
Ph: (0823) 22-3111

Takashi Sawasaki
Principal Investigator

Morioka

Iwate Medical University School of Medicine

Toru Sugiyama
Ph: 019-651-5111

Toru Sugiyama
Principal Investigator

Nakagami-gun

University of the Ryukyus Hospital-Col Health Scnc

Yoichi Aoki
Ph: 888-823-5923
Email: ctsucontact@westat.com

Yoichi Aoki
Principal Investigator

Niigata City

Niigata University Medical and Dental Hospital

Takayuki Enomoto
Ph: 81-025-223-6161

Takayuki Enomoto
Principal Investigator

Osaka, Osaka

Kinki University

Masaki Mandai
Ph: 072-366-0221

Masaki Mandai
Principal Investigator

Saitama

Saitama Medical University International Medical Center

Keiichi Fujiwara
Ph: 81-49-276-2028

Keiichi Fujiwara
Principal Investigator

Sapporo

Hokkaido University Hospital

Noriaki Sakuragi
Email: hassi@med.hokudai.ac.jp

Noriaki Sakuragi
Principal Investigator

Sendai

Tohoku University School of Medicine

Nobuo Yaegashi
Email: med-som@bureau.tohoku.ac.jp

Nobuo Yaegashi
Principal Investigator

Tottori

Tottori University

Hiroaki Itamochi
Ph: 0857-31-5007

Hiroaki Itamochi
Principal Investigator

Republic of Korea

Seongnam City

Seoul National University Bundang Hospital

Jae Hong No
Ph: 888-823-5923
Email: ctsucontact@westat.com

Jae Hong No
Principal Investigator

Seoul

Catholic University of Korea-Seoul Saint Mary's Hospital

Keun Ho Lee
Ph: 2258-5745-6

Keun Ho Lee
Principal Investigator

Gangnam Severance Hospital

Jae-Hoon Kim
Email: clinical.trial@bms.com

Jae-Hoon Kim
Principal Investigator

Korea Cancer Center Hospital

Moon-Hong Kim
Ph: 011-82-02-9702-114

Moon-Hong Kim
Principal Investigator

Samsung Medical Center

Joo-Hyun Nam
Ph: 011-82-760-2384

Joo-Hyun Nam
Principal Investigator

United Kingdom

Sheffield

Weston Park Hospital

Matthew Christopher Winter
Ph: 888-823-5923
Email: ctsucontact@westat.com

Matthew Christopher Winter
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01535053

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.