Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIISupportive care, Treatment18 and overANZGOG-0902/GOG-0274/RTOG-1174
NCI-2011-02978, ANZGOG-0902, CDR0000706698, GOG-0274, RTOG-1174, ANZGOG-0902-GOG-0274, NCT01414608

Trial Description

Summary

This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves overall survival.

SECONDARY OBJECTIVES:

I. To determine the progression-free survival rates.

II. To determine acute and long-term toxicities.

III. To determine patterns of disease recurrence.

IV. To determine the association between radiation protocol compliance and outcomes.

V. To determine patient quality of life, including psycho-sexual health.

TERTIARY OBJECTIVES:

I. To determine the association between the results of a follow-up positron emission tomography (PET) scan performed 4–6 months post completion of chemoradiation and outcomes for all patients in the trial.

II. To determine the biological predictors of patients' outcomes based on translational laboratory studies of blood and tissue specimens.

OUTLINE: This is a multicenter study. Patients are stratified according to pelvic or common iliac nodal involvement (yes vs no), requirement for extended-field radiotherapy treatment (yes vs no), International Federation of Gynecology and Obstetrics (FIGO) stage (IB/IIA vs IIB vs IIIB/IVA), age (< 60 years of age vs >= 60 years of age), and hospital/site. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy.

ARM II: Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo baseline tumor biopsy and blood collection for future correlative studies.

Patients complete the European Organization for Research and Treatment of Cancer (EORTC) Core questionnaire (QLQ-C30), the EORTC cervix cancer module (CX24), the ovarian cancer module (OV28), and the Sexual function-Vaginal Changes Questionnaire (SVQ) questionnaires at baseline, during, and after completion of study treatment.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria:

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN

Platelet count >= 100 x 10^9/L

Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix

Creatinine =< ULN (Common Toxicity Criteria [CTC] Grade 0) OR calculated creatinine clearance (Cockcroft-Gault Formula) >= 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance

Bilirubin =< 1.5 times upper limit of normal (ULN)

Written informed consent

Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to:

Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix

FIGO 2008 stage IB1 & node positive, IB2, II, IIIB, or IVA disease

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

White blood cells (WBC) >= 3.0 x 10^9/L

Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

Exclusion Criteria:

Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years

Patients who are pregnant or lactating

Previous chemotherapy for this tumor

Evidence of distant metastases

Prior diagnosis of Crohn disease or ulcerative colitis

Any previous pelvic radiotherapy

Human immunodeficiency virus (HIV) positive

Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] v. 4)

Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria

Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

FIGO 2008 stage IIIA disease

Patients assessed at presentation as requiring interstitial brachytherapy treatment

Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy

Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy

Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive, or >= 15 mm short-axis diameter on computed tomography [CT])

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Gynecologic Oncology Group

  • National Cancer Institute
Kathleen N. Moore, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

University of Alabama at Birmingham Cancer Center

Warner King Huh
Ph: 205-934-0309

Warner King Huh
Principal Investigator

Mobile

University of South Alabama Mitchell Cancer Institute

Rodney Paul Rocconi
Ph: 251-445-9870
Email: pfrancisco@usouthal.edu

Rodney Paul Rocconi
Principal Investigator

Alaska
Anchorage

Alaska Women's Cancer Care

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

Matthew C. Solhjem
Principal Investigator

Providence Alaska Medical Center

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

Matthew C. Solhjem
Principal Investigator

Arizona
Phoenix

Arizona Oncology Associates-Biltmore Cancer Center

Michael A. Bookman
Ph: 520-626-9008

Michael A. Bookman
Principal Investigator

Gynecologic Oncology Group of Arizona

Kathleen N. Moore
Ph: 405-271-8707
Email: lreese@gog.org

Kathleen N. Moore
Principal Investigator

Saint Joseph's Hospital and Medical Center

John Hall Farley
Ph: 301-319-2100

John Hall Farley
Principal Investigator

Arkansas
Little Rock

University of Arkansas for Medical Sciences

Kristin Kelley Zorn
Ph: 501-686-8274

Kristin Kelley Zorn
Principal Investigator

California
Concord

John Muir Medical Center-Concord Campus

Babak Edraki
Ph: 925-674-2580

Babak Edraki
Principal Investigator

Fremont

Kaiser Permanente-Fremont

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Mountain View

Palo Alto Medical Foundation-Gynecologic Oncology

John K. Chan
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

John K. Chan
Principal Investigator

Oakland

Kaiser Permanente-Oakland

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Orange

Saint Joseph Hospital - Orange

Michael L. Berman
Ph: 877-827-8839
Email: ucstudy@uci.edu

Michael L. Berman
Principal Investigator

UC Irvine Health/Chao Family Comprehensive Cancer Center

Krishnansu Sujata Tewari
Ph: 714-456-6191
Email: awallick@uci.edu

Krishnansu Sujata Tewari
Principal Investigator

Roseville

Kaiser Permanente-Roseville

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Sacramento

University of California Davis Comprehensive Cancer Center

Gary S. Leiserowitz
Ph: 916-734-3089

Gary S. Leiserowitz
Principal Investigator

San Francisco

Kaiser Permanente-San Francisco

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Sylmar

Olive View-University of California Los Angeles Medical Center

Christine H. Holschneider
Ph: 888-798-0719

Christine H. Holschneider
Principal Investigator

Vallejo

Kaiser Permanente-Vallejo

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Walnut Creek

John Muir Medical Center-Walnut Creek

Babak Edraki
Ph: 925-674-2580

Babak Edraki
Principal Investigator

Colorado
Aurora

Rocky Mountain Cancer Centers-Aurora

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

The Medical Center of Aurora

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Saketh Ram Guntupalli
Ph: 720-848-0650

Saketh Ram Guntupalli
Principal Investigator

Boulder

Boulder Community Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Boulder

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Colorado Springs

Rocky Mountain Cancer Centers-Penrose

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Denver

Colorado Blood Cancer Institute

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Colorado Cancer Research Program CCOP

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Exempla Saint Joseph Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Porter Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Presbyterian - Saint Lukes Medical Center - Health One

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Midtown

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Rose

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rose Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Durango

Southwest Oncology PC

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Englewood

Comprehensive Cancer Care and Research Institute of Colorado LLC

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Swedish Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Greeley

North Colorado Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Greenwood Village

Rocky Mountain Cancer Centers-Greenwood Village

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Lakewood

Rocky Mountain Cancer Centers-Lakewood

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Saint Anthony Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Littleton

Littleton Adventist Hospital

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Littleton

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Lone Tree

Rocky Mountain Cancer Centers-Sky Ridge

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Sky Ridge 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

Rocky Mountain Cancer Centers-Longmont

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

Rocky Mountain Cancer Centers-Parker

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Pueblo

Rocky Mountain Cancer Centers - Pueblo

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Saint Mary Corwin Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Thornton

Rocky Mountain Cancer Centers-Thornton

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Wheat Ridge

Exempla Lutheran Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Connecticut
Hartford

Hartford Hospital

James S. Hoffman
Ph: 860-224-5660

James S. Hoffman
Principal Investigator

New Britain

The Hospital of Central Connecticut

James S. Hoffman
Ph: 860-224-5660

James S. Hoffman
Principal Investigator

New Haven

Yale University

Peter Edward Schwartz
Ph: 203-785-5702

Peter Edward Schwartz
Principal Investigator

Florida
Deerfield Beach

University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

Aaron H. Wolfson
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Aaron H. Wolfson
Principal Investigator

Miami

Jackson Memorial Hospital-Holtz Children's Hospital

Aaron H. Wolfson
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Aaron H. Wolfson
Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

Aaron H. Wolfson
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Aaron H. Wolfson
Principal Investigator

Orlando

UF Cancer Center at Orlando Health

Kathleen N. Moore
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Kathleen N. Moore
Principal Investigator

Georgia
Atlanta

Emory University/Winship Cancer Institute

Joseph William Shelton
Ph: 404-489-9164

Joseph William Shelton
Principal Investigator

Grady Health System

Joseph William Shelton
Ph: 404-489-9164

Joseph William Shelton
Principal Investigator

Northside Hospital

Sahar Esther Rosenbaum
Ph: 404-303-3355

Sahar Esther Rosenbaum
Principal Investigator

Gainesville

Northeast Georgia Medical Center

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

Andrew Emmons Green
Principal Investigator

Hawaii
Honolulu

Kaiser Permanente Moanalua Medical Center

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Kapiolani Medical Center for Women and Children

Michael Ethan Carney
Ph: 808-983-6090

Michael Ethan Carney
Principal Investigator

Queen's Medical Center

Michael Ethan Carney
Ph: 808-983-6090

Michael Ethan Carney
Principal Investigator

University of Hawaii Cancer Center

Michael Ethan Carney
Ph: 808-983-6090

Michael Ethan Carney
Principal Investigator

Illinois
Bloomington

Illinois CancerCare-Bloomington

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

James Lloyd Wade
Principal Investigator

Saint Joseph Medical Center

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

James Lloyd Wade
Principal Investigator

Canton

Illinois CancerCare-Canton

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

James Lloyd Wade
Principal Investigator

Carthage

Illinois CancerCare-Carthage

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

James Lloyd Wade
Principal Investigator

Chicago

John H Stroger Jr Hospital of Cook County

Thomas E. Lad
Ph: 312-864-6000

Thomas E. Lad
Principal Investigator

Northwestern University

Eric D. Donnelly
Ph: 312-695-1301
Email: cancer@northwestern.edu

Eric D. Donnelly
Principal Investigator

University of Chicago Comprehensive Cancer Center

Meaghan Elizabeth Tenney
Ph: 773-834-7424

Meaghan Elizabeth Tenney
Principal Investigator

Eureka

Illinois CancerCare-Eureka

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

James Lloyd Wade
Principal Investigator

Galesburg

Illinois CancerCare Galesburg

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

James Lloyd Wade
Principal Investigator

Western Illinois Cancer Treatment Center

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

James Lloyd Wade
Principal Investigator

Hinsdale

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Sudarshan K. Sharma
Ph: 630-856-6757

Sudarshan K. Sharma
Principal Investigator

Kewanee

Illinois CancerCare-Kewanee Clinic

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

James Lloyd Wade
Principal Investigator

Macomb

Illinois CancerCare-Macomb

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

James Lloyd Wade
Principal Investigator

Maywood

Loyola University Medical Center

William Small
Ph: 708-226-4357

William Small
Principal Investigator

Ottawa

Illinois CancerCare-Ottawa Clinic

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

James Lloyd Wade
Principal Investigator

Pekin

Pekin Cancer Treatment Center

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Peoria

Illinois CancerCare-Peoria

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Methodist Medical Center of Illinois

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

OSF Saint Francis Medical Center

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC

Nguyet Anh Le-Lindqwister
Ph: 800-793-2262

Nguyet Anh Le-Lindqwister
Principal Investigator

Peru

Illinois CancerCare-Peru

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

James Lloyd Wade
Principal Investigator

Valley Radiation Oncology

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

James Lloyd Wade
Principal Investigator

Princeton

Illinois CancerCare-Princeton

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

James Lloyd Wade
Principal Investigator

Indiana
Elkhart

Michiana Hematology Oncology PC-Elkhart

Kathleen N. Moore
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Kathleen N. Moore
Principal Investigator

Indianapolis

Saint Vincent Oncology Center

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

Michael J. Callahan
Principal Investigator

Mishawaka

Saint Joseph Regional Medical Center-Mishawaka

Kathleen N. Moore
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Kathleen N. Moore
Principal Investigator

Iowa
Iowa City

University of Iowa/Holden Comprehensive Cancer Center

David Paul Bender
Ph: 800-237-1225

David Paul Bender
Principal Investigator

Kansas
Kansas City

University of Kansas Cancer Center

Julia Ann Chapman
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Julia Ann Chapman
Principal Investigator

Kentucky
Lexington

Baptist Health Lexington

Hope McClain Cottrill
Ph: 859-260-6425

Hope McClain Cottrill
Principal Investigator

University of Kentucky/Markey Cancer Center

Frederick Rand Ueland
Ph: 859-257-3379

Frederick Rand Ueland
Principal Investigator

Louisiana
New Orleans

Louisiana State University Health Science Center

Augusto C. Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

Augusto C. Ochoa
Principal Investigator

Ochsner Medical Center Jefferson

Richard Carl Kline
Ph: 888-562-4763

Richard Carl Kline
Principal Investigator

Tulane University Health Sciences Center

William Russell Robinson
Ph: 504-988-6121

William Russell Robinson
Principal Investigator

Maryland
Baltimore

University of Maryland/Greenebaum Cancer Center

Gautam Gorantla Rao
Ph: 800-888-8823

Gautam Gorantla Rao
Principal Investigator

Bethesda

Walter Reed National Military Medical Center

Michael P. Stany
Ph: 301-319-2100

Michael P. Stany
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

Detroit

Henry Ford Hospital

Thomas E. Buekers
Ph: 313-916-1784

Thomas E. Buekers
Principal Investigator

Wayne State University/Karmanos Cancer Institute

Robert Thomas Morris
Ph: 313-576-9363

Robert Thomas Morris
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

Royal Oak

William Beaumont Hospital-Royal Oak

Jayson B. Field
Ph: 248-551-7695

Jayson B. Field
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
Minneapolis

University of Minnesota Medical Center-Fairview

Peter Alexander Argenta
Ph: 612-624-2620

Peter Alexander Argenta
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

Mississippi
Jackson

University of Mississippi Medical Center

James Tate Thigpen
Ph: 601-815-6700

James Tate Thigpen
Principal Investigator

Missouri
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

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

Saint Patrick Hospital - Community Hospital

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Nebraska
Omaha

Nebraska Methodist Hospital

Peter Craig Morris
Ph: 402-354-7939
Email: kathryn.bartz@nmhs.org

Peter Craig Morris
Principal Investigator

Nevada
Las Vegas

Women's Cancer Center of Nevada

Nicola M. Spirtos
Ph: 702-851-4672

Nicola M. Spirtos
Principal Investigator

New Hampshire
Dover

Wentworth-Douglass Hospital

John Orland Schorge
Ph: 877-726-5130

John Orland Schorge
Principal Investigator

New Jersey
Camden

Cooper Hospital University Medical Center

David Philip Warshal
Ph: 856-325-6757

David Philip Warshal
Principal Investigator

Hackensack

Hackensack University Medical Center

Donna Trauth McNamara
Ph: 201-996-2879

Donna Trauth McNamara
Principal Investigator

Morristown

Morristown Medical Center

Yana Pavel Goldberg
Ph: 973-971-5900

Yana Pavel Goldberg
Principal Investigator

Neptune

Jersey Shore Medical Center

Karim Samir ElSahwi
Ph: 732-776-4240

Karim Samir ElSahwi
Principal Investigator

New Brunswick

Rutgers Cancer Institute of New Jersey

Darlene Grace Gibbon
Ph: 732-235-8675

Darlene Grace Gibbon
Principal Investigator

New Mexico
Albuquerque

Southwest Gynecologic Oncology Associates Inc

Teresa L. Rutledge
Ph: 505-272-6972

Teresa L. Rutledge
Principal Investigator

University of New Mexico

Kathleen N. Moore
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Kathleen N. Moore
Principal Investigator

University of New Mexico Cancer Center

Teresa L. Rutledge
Ph: 505-272-6972

Teresa L. Rutledge
Principal Investigator

New York
Brooklyn

The New York Methodist Hospital

Katherine Economos
Ph: 718-780-5240

Katherine Economos
Principal Investigator

Buffalo

Roswell Park Cancer Institute

Peter Jonathan Frederick
Ph: 877-275-7724

Peter Jonathan Frederick
Principal Investigator

Manhasset

North Shore University Hospital

Veena Susan John
Ph: 516-562-3467

Veena Susan John
Principal Investigator

Mineola

Winthrop University Hospital

Eva Chalas
Ph: 866-946-8476

Eva Chalas
Principal Investigator

New Hyde Park

Long Island Jewish Medical Center

Veena Susan John
Ph: 516-562-3467

Veena Susan John
Principal Investigator

North Shore-LIJ Health System/Center for Advanced Medicine

Veena Susan John
Ph: 516-562-3467

Veena Susan John
Principal Investigator

New York

Laura and Issac Perlmutter Cancer Center at NYU Langone

Stephanie V. Blank
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

Stephanie V. Blank
Principal Investigator

Memorial Sloan-Kettering Cancer Center

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

Stony Brook

Stony Brook University Medical Center

Michael L. Pearl
Ph: 800-862-2215

Michael L. Pearl
Principal Investigator

West Harrison

Memorial Sloan-Kettering Cancer Center West Harrison

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

North Carolina
Burlington

Cone Health Cancer Center at Alamance Regional

Janak Kantilal Choksi
Ph: 336-538-7725

Janak Kantilal Choksi
Principal Investigator

Charlotte

Carolinas Medical Center/Levine Cancer Institute

Robert Victor Higgins
Ph: 704-355-2884

Robert Victor Higgins
Principal Investigator

Concord

Carolinas HealthCare System NorthEast

Robert Victor Higgins
Ph: 704-355-2884

Robert Victor Higgins
Principal Investigator

Ohio
Akron

Summa Akron City Hospital/Cooper Cancer Center

Vivian E. von Gruenigen
Ph: 330-375-6101

Vivian E. von Gruenigen
Principal Investigator

Cincinnati

University of Cincinnati

Eric Lawrence Eisenhauer
Ph: 513-558-4553
Email: uchealthnews@uc.edu

Eric Lawrence Eisenhauer
Principal Investigator

Cleveland

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

MetroHealth Medical Center

Peter G. Rose
Ph: 866-223-8100

Peter G. Rose
Principal Investigator

Columbus

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

Dayton

Miami Valley 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

Mayfield Heights

Hillcrest Hospital Cancer Center

Peter G. Rose
Ph: 866-223-8100

Peter G. Rose
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

Oregon
Portland

Providence Portland Medical Center

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

Matthew C. Solhjem
Principal Investigator

Pennsylvania
Abington

Abington Memorial Hospital

Parviz Hanjani
Ph: 215-481-2402

Parviz Hanjani
Principal Investigator

Bethlehem

Saint Luke's University Hospital-Bethlehem Campus

Nicholas P. Taylor
Ph: 610-954-3582
Email: infolink@slhn.org

Nicholas P. Taylor
Principal Investigator

Philadelphia

Drexel University School of Medicine

Scott Daniel Richard
Ph: 866-884-4484

Scott Daniel Richard
Principal Investigator

Gynecologic Oncology Group

Philip J. DiSaia
Ph: 215-854-0770
Email: lreese@gog.org

Kathleen N. Moore
Principal Investigator

Thomas Jefferson University Hospital

Pramila Rani Anne
Ph: 215-955-6084

Pramila Rani Anne
Principal Investigator

Pittsburgh

UPMC-Magee Womens Hospital

Dwight Earl Heron
Ph: 412-647-8073

Dwight Earl Heron
Principal Investigator

UPMC-Shadyside Hospital

Dwight Earl Heron
Ph: 412-647-8073

Dwight Earl Heron
Principal Investigator

West Reading

Reading Hospital

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

Bernice L. Robinson-Bennett
Principal Investigator

Rhode Island
Providence

Women and Infants Hospital

Paul A. DiSilvestro
Ph: 401-274-1122

Paul A. DiSilvestro
Principal Investigator

South Carolina
Anderson

AnMed Health Cancer Center

David Griffin
Ph: 864-512-1000

David Griffin
Principal Investigator

Charleston

Medical University of South Carolina

Jennifer L. Young Pierce
Ph: 843-792-9321

Jennifer L. Young Pierce
Principal Investigator

Greenville

Saint Francis Hospital

David Griffin
Ph: 864-512-1000

David Griffin
Principal Investigator

Spartanburg

Spartanburg Medical Center

David Griffin
Ph: 864-512-1000

David Griffin
Principal Investigator

South Dakota
Rapid City

Black Hills Obstetrics and Gynecology

Helen L. Frederickson
Ph: 605-343-9224

Helen L. Frederickson
Principal Investigator

Rapid City Regional Hospital

Helen L. Frederickson
Ph: 605-343-9224

Helen L. Frederickson
Principal Investigator

Texas
Austin

Texas Oncology - Central Austin Cancer Center

Michael A. Bookman
Ph: 520-626-9008

Michael A. Bookman
Principal Investigator

Texas Oncology - South Austin Cancer Center

Michael A. Bookman
Ph: 520-626-9008

Michael A. Bookman
Principal Investigator

Texas Oncology-Austin Midtown

Michael A. Bookman
Ph: 520-626-9008

Michael A. Bookman
Principal Investigator

Bedford

Texas Oncology Bedford

Michael A. Bookman
Ph: 520-626-9008

Michael A. Bookman
Principal Investigator

Dallas

Texas Oncology at Baylor Charles A Sammons Cancer Center

Michael A. Bookman
Ph: 520-626-9008

Michael A. Bookman
Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

David Scott Miller
Ph: 214-648-7097

David Scott Miller
Principal Investigator

Fort Worth

Texas Oncology Fort Worth at 12th Avenue

Michael A. Bookman
Ph: 520-626-9008

Michael A. Bookman
Principal Investigator

Houston

Lyndon Baines Johnson General Hospital

Lois M. Ramondetta
Ph: 713-792-3245

Lois M. Ramondetta
Principal Investigator

M D Anderson Cancer Center

Lois M. Ramondetta
Ph: 713-792-3245

Lois M. Ramondetta
Principal Investigator

Lois M. Ramondetta
Email: lramonde@mdanderson.org

Lois M. Ramondetta
Principal Investigator

The Methodist Hospital System

Aparna A. Kamat
Ph: 713-790-2700

Aparna A. Kamat
Principal Investigator

Utah
Salt Lake City

Huntsman Cancer Institute/University of Utah

Matthew M. Poppe
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Matthew M. Poppe
Principal Investigator

Virginia
Charlottesville

University of Virginia Cancer Center

Susan Carnall Modesitt
Ph: 434-243-6143

Susan Carnall Modesitt
Principal Investigator

Richmond

Virginia Commonwealth University/Massey Cancer Center

Weldon E. Chafe
Ph: 804-628-1939

Weldon E. Chafe
Principal Investigator

Roanoke

Carilion Clinic Gynecological Oncology

Janet L. Osborne
Ph: 540-985-8510

Janet L. Osborne
Principal Investigator

Wisconsin
Green Bay

Aurora BayCare Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Madison

University of Wisconsin Hospital and Clinics

Kristin A. Bradley
Ph: 877-405-6866

Kristin A. Bradley
Principal Investigator

Milwaukee

Aurora Saint Luke's Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Froedtert and the Medical College of Wisconsin

William H. Bradley
Ph: 414-805-4380

William H. Bradley
Principal Investigator

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Wyoming
Cheyenne

Cheyenne Regional Medical Center-West

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Sheridan

Welch Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Canada

Ontario
Hamilton

Juravinski Cancer Centre at Hamilton Health Sciences

Lorraine (Laurie) M. Elit
Ph: 905-387-9495

Lorraine (Laurie) M. Elit
Principal Investigator

Toronto

University Health Network-Princess Margaret Hospital

Anthony William Fyles
Ph: 416-946-4501
Email: clinical.trials@uhn.on.ca

Anthony William Fyles
Principal Investigator

Quebec
Montreal

CHUM - Hopital Notre-Dame

Maroie Barkati
Ph: 514-890-8000ext23611
Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

Maroie Barkati
Principal Investigator

Saskatchewan
Regina

Allan Blair Cancer Centre

Evgeny Sadikov
Ph: 306-766-2213

Evgeny Sadikov
Principal Investigator

Saudi Arabia

Riyadh

King Faisal Specialist Hospital and Research Centre

Hamed Homoud Al-Husaini
Ph: 011-966-1-464-7272 ext 38005

Hamed Homoud Al-Husaini
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01414608

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.