Cisplatin and Radiation Therapy with or without Carboplatin and Paclitaxel in Patients with Locally Advanced Cervical Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIISupportive care, TreatmentActive18 and overANZGOG-0902-GOG-0274
NCI-2011-02978, CDR0000706698, GOG-0274, RTOG-1174, ANZGOG-0902, ANZGOG-0902-GOG-0274/RTOG-1174, 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 cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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: 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 treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria:

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

Federation of Gynecology and Obstetrics (FIGO) 2008 stage IB1 & node positive, IB2, IIA, IIB, IIIB, or IVA disease

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

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

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

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

Platelet count >= 100 x 10^9/L

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

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN (if both tests are done, both results need to be =< 2.5 x ULN)

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

Written informed consent

Exclusion Criteria:

Any previous pelvic radiotherapy

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])

FIGO 2008 stage IIIA disease

Patients assessed at presentation as requiring interstitial brachytherapy treatment

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

Previous chemotherapy for this tumor

Evidence of distant metastases

Prior diagnosis of Crohn's disease or ulcerative colitis

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

Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy

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

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

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

Patients who are known to be human immunodeficiency virus (HIV) positive

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • 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

Benjamin Buckner Bridges
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Benjamin Buckner Bridges
Principal Investigator

Providence Alaska Medical Center

Benjamin Buckner Bridges
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Benjamin Buckner Bridges
Principal Investigator

Arizona
Phoenix

Gynecologic Oncology Group of Arizona

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

Kathleen N. Moore
Principal Investigator

University of Arizona Cancer Center at Saint Joseph's

John Hall Farley
Ph: 877-602-4111

John Hall Farley
Principal Investigator

Tucson

Arizona Oncology Associates-West Orange Grove

Michael A. Bookman
Ph: 520-269-3821

Michael A. Bookman
Principal Investigator

Arizona Oncology Associates-Wilmot

Michael A. Bookman
Ph: 520-269-3821

Michael A. Bookman
Principal Investigator

Arkansas
Little Rock

University of Arkansas for Medical Sciences

Kristin Kelley Zorn
Ph: 501-686-8274

Kristin Kelley Zorn
Principal Investigator

California
Auburn

Sutter Auburn Faith Hospital

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Sutter Cancer Centers Radiation Oncology Services-Auburn

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Berkeley

Alta Bates Summit Medical Center-Herrick Campus

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Burlingame

Mills - Peninsula Hospitals

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Cameron Park

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Concord

John Muir Medical Center-Concord Campus

Babak Edraki
Ph: 925-674-2580

Babak Edraki
Principal Investigator

Davis

Sutter Davis Hospital

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Fremont

Kaiser Permanente-Fremont

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Modesto

Memorial Medical Center

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Mountain View

Palo Alto Medical Foundation-Camino Division

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Palo Alto Medical Foundation-Gynecologic Oncology

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
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

Palo Alto

Palo Alto Medical Foundation Health Care

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Roseville

Kaiser Permanente-Roseville

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Sutter Cancer Centers Radiation Oncology Services-Roseville

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Sutter Roseville Medical Center

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Sacramento

Mercy Medical Group

Kevin Scott Elliott
Ph: 916-556-3200

Kevin Scott Elliott
Principal Investigator

Sutter General Hospital

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

University of California Davis Comprehensive Cancer Center

Vanessa A. Kennedy
Ph: 916-734-3089

Vanessa A. Kennedy
Principal Investigator

San Francisco

California Pacific Medical Center-Pacific Campus

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Kaiser Permanente-San Francisco

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

San Rafael

Kaiser Permanente-San Rafael

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Santa Clara

Kaiser Permanente Medical Center - Santa Clara

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Santa Cruz

Palo Alto Medical Foundation-Santa Cruz

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Santa Rosa

Sutter Pacific Medical Foundation

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

South San Francisco

Kaiser Permanente-South San Francisco

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Sunnyvale

Palo Alto Medical Foundation-Sunnyvale

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Sylmar

Olive View-University of California Los Angeles Medical Center

Christine H. Holschneider
Ph: 888-798-0719

Christine H. Holschneider
Principal Investigator

Vacaville

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
Principal Investigator

Vallejo

Kaiser Permanente-Vallejo

Tatjana Kolevska
Ph: 626-564-3455

Tatjana Kolevska
Principal Investigator

Sutter Solano Medical Center/Cancer Center

Stacy D. D'Andre
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Stacy D. D'Andre
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: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Boulder

Rocky Mountain Cancer Centers-Boulder

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Colorado Springs

Penrose-Saint Francis Healthcare

Mehmet Sitki Copur
Ph: 800-998-2119

Mehmet Sitki Copur
Principal Investigator

Denver

Colorado Blood Cancer Institute

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Colorado Cancer Research Program NCORP

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Midtown

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Rocky Mountain Cancer Centers-Rose

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

SCL Health Saint Joseph Hospital

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Englewood

Comprehensive Cancer Care and Research Institute of Colorado LLC

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Swedish Medical Center

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Greeley

North Colorado Medical Center

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Littleton

Rocky Mountain Cancer Centers-Littleton

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Lone Tree

Rocky Mountain Cancer Centers-Sky Ridge

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Loveland

McKee Medical Center

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Wheat Ridge

SCL Health Lutheran Medical Center

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Connecticut
Hartford

Hartford Hospital

Amy Kirkpatrick Brown
Ph: 860-545-5363

Amy Kirkpatrick Brown
Principal Investigator

New Britain

The Hospital of Central Connecticut

Amy Kirkpatrick Brown
Ph: 860-545-5363

Amy Kirkpatrick Brown
Principal Investigator

New Haven

Yale University

Peter Edward Schwartz
Ph: 203-785-5702

Peter Edward Schwartz
Principal Investigator

Florida
Deerfield Beach

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Aaron H. Wolfson
Ph: 305-243-2647

Aaron H. Wolfson
Principal Investigator

Miami

Jackson Memorial Hospital-Holtz Children's Hospital

Aaron H. Wolfson
Ph: 305-243-2647

Aaron H. Wolfson
Principal Investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

Aaron H. Wolfson
Ph: 305-243-2647

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 Hospital Midtown

Joseph William Shelton
Ph: 404-778-1868

Joseph William Shelton
Principal Investigator

Emory University/Winship Cancer Institute

Joseph William Shelton
Ph: 404-778-1868

Joseph William Shelton
Principal Investigator

Grady Health System

Joseph William Shelton
Ph: 404-778-1868

Joseph William Shelton
Principal Investigator

Northside Hospital

Daniel Shasha
Ph: 404-303-3355

Daniel Shasha
Principal Investigator

Gainesville

Northeast Georgia Medical Center-Gainesville

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

Andrew Emmons Green
Principal Investigator

Hawaii
Ewa Beach

The Cancer Center of Hawaii-Leeward

Michael Ethan Carney
Ph: 808-983-6090

Michael Ethan Carney
Principal Investigator

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

The Cancer Center of Hawaii-Liliha

Michael Ethan Carney
Ph: 808-983-6090

Michael Ethan Carney
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

J. Rebecca Liu
Ph: 734-712-3456

J. Rebecca Liu
Principal Investigator

Saint Luke's Mountain States Tumor Institute

Benjamin Buckner Bridges
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Benjamin Buckner Bridges
Principal Investigator

Coeur D'Alene

Kootenai Medical Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Fruitland

Saint Luke's Mountain States Tumor Institute - Fruitland

Benjamin Buckner Bridges
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Benjamin Buckner Bridges
Principal Investigator

Meridian

Saint Luke's Mountain States Tumor Institute - Meridian

Benjamin Buckner Bridges
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Benjamin Buckner Bridges
Principal Investigator

Nampa

Saint Luke's Mountain States Tumor Institute - Nampa

Benjamin Buckner Bridges
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Benjamin Buckner Bridges
Principal Investigator

Post Falls

Kootenai Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Sandpoint

Kootenai Cancer Clinic

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Twin Falls

Saint Luke's Mountain States Tumor Institute-Twin Falls

Benjamin Buckner Bridges
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Benjamin Buckner Bridges
Principal Investigator

Illinois
Bloomington

Illinois CancerCare-Bloomington

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

Centralia

Centralia Oncology Clinic

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

Rush University Medical Center

Alfred S. Guirguis
Ph: 312-942-5498
Email: clinical_trials@rush.edu

Alfred S. Guirguis
Principal Investigator

University of Chicago Comprehensive Cancer Center

John William Moroney
Email: jmoroney@bsd.uchicago.edu

John William Moroney
Principal Investigator

Decatur

Cancer Care Center of Decatur

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

James Lloyd Wade
Principal Investigator

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

Eureka

Illinois CancerCare-Eureka

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

James Lloyd Wade
Principal Investigator

Evanston

NorthShore University HealthSystem-Evanston Hospital

Elena S. Diaz-Moore
Ph: 847-570-2109

Elena S. Diaz-Moore
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

Geneva

Northwestern Medicine Cancer Center Delnor

LaToya J. Perry
Ph: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org

LaToya J. Perry
Principal Investigator

Glenview

NorthShore University HealthSystem-Glenbrook Hospital

Elena S. Diaz-Moore
Ph: 847-570-2109

Elena S. Diaz-Moore
Principal Investigator

Highland Park

NorthShore University HealthSystem-Highland Park Hospital

Elena S. Diaz-Moore
Ph: 847-570-2109

Elena S. Diaz-Moore
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

Ottawa

Illinois CancerCare-Ottawa Clinic

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

James Lloyd Wade
Principal Investigator

Pekin

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

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

James Lloyd Wade
Principal Investigator

Peoria

Illinois CancerCare-Peoria

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

James Lloyd Wade
Principal Investigator

Methodist Medical Center of Illinois

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

James Lloyd Wade
Principal Investigator

OSF Saint Francis Medical Center

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

James Lloyd Wade
Principal Investigator

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

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

James Lloyd Wade
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

Springfield

Memorial Medical Center

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

James Lloyd Wade
Principal Investigator

Southern Illinois University School of Medicine

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

James Lloyd Wade
Principal Investigator

Springfield Clinic

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

James Lloyd Wade
Principal Investigator

Warrenville

Northwestern Medicine Cancer Center Warrenville

LaToya J. Perry
Ph: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org

LaToya J. Perry
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 Hospital and Health Care 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

Munster

The Community Hospital

Mohamad Kassar
Ph: 219-836-3349

Mohamad Kassar
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

Louisville

Norton Hospital Pavilion and Medical Campus

Mary Evelyn Gordinier
Ph: 502-629-2500

Mary Evelyn Gordinier
Principal Investigator

Louisiana
Baton Rouge

Woman's Hospital

M. Giles Fort
Ph: 225-231-5296
Email: Ericka.Seidemann@womans.org

M. Giles Fort
Principal Investigator

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

University Medical Center New Orleans

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

Augusto C. Ochoa
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
Springfield

Baystate Medical Center

Tashanna Keisha Nicole Myers
Ph: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

Tashanna Keisha Nicole Myers
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

J. Rebecca Liu
Ph: 734-712-3456

J. Rebecca Liu
Principal Investigator

Battle Creek

Bronson Battle Creek

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
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

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Spectrum Health at Butterworth Campus

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Kalamazoo

West Michigan Cancer Center

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Lansing

Sparrow Hospital

J. Rebecca Liu
Ph: 734-712-3456

J. Rebecca Liu
Principal Investigator

Royal Oak

William Beaumont Hospital-Royal Oak

Jayson Bert Field
Ph: 248-551-7695

Jayson Bert Field
Principal Investigator

Traverse City

Munson Medical Center

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Minnesota
Minneapolis

University of Minnesota/Masonic Cancer Center

Peter Alexander Argenta
Ph: 612-624-2620

Peter Alexander Argenta
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

Bozeman

Bozeman Deaconess Hospital

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

Nebraska
Omaha

Nebraska Methodist Hospital

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

Peter Craig Morris
Principal Investigator

University of Nebraska Medical Center

Kerry Julene Rodabaugh
Ph: 402-559-6941
Email: unmcrsa@unmc.edu

Kerry Julene Rodabaugh
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

Neptune

Jersey Shore Medical Center

Karim Samir ElSahwi
Ph: 732-776-4240

Karim Samir ElSahwi
Principal Investigator

Voorhees

MD Anderson Cancer Center at Cooper-Voorhees

David Philip Warshal
Ph: 856-325-6757

David Philip Warshal
Principal Investigator

New Mexico
Albuquerque

Lovelace Radiation Oncology

Teresa L. Rutledge
Ph: 505-925-0366
Email: LByatt@nmcca.org

Teresa L. Rutledge
Principal Investigator

Southwest Gynecologic Oncology Associates Inc

Teresa L. Rutledge
Ph: 505-925-0366
Email: LByatt@nmcca.org

Teresa L. Rutledge
Principal Investigator

University of New Mexico Cancer Center

Teresa L. Rutledge
Ph: 505-925-0366
Email: LByatt@nmcca.org

Teresa L. Rutledge
Principal Investigator

Las Cruces

Memorial Medical Center - Las Cruces

Teresa L. Rutledge
Ph: 505-925-0366
Email: LByatt@nmcca.org

Teresa L. Rutledge
Principal Investigator

New York
Brooklyn

New York-Presbyterian/Brooklyn Methodist Hospital

Katherine Economos
Ph: 718-780-3677
Email: Adg9003@nyp.org

Katherine Economos
Principal Investigator

Manhasset

North Shore University Hospital

Veena Susan John
Ph: 516-734-8954

Veena Susan John
Principal Investigator

New Hyde Park

Long Island Jewish Medical Center

Veena Susan John
Ph: 516-734-8954

Veena Susan John
Principal Investigator

North Shore-LIJ Health System/Center for Advanced Medicine

Veena Susan John
Ph: 516-734-8954

Veena Susan John
Principal Investigator

New York

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Leslie R. Boyd
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

Leslie R. Boyd
Principal Investigator

Memorial Sloan-Kettering Cancer Center

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

Rochester

Highland Hospital

Richard G. Moore
Ph: 585-275-5830

Richard G. Moore
Principal Investigator

University of Rochester

Richard G. Moore
Ph: 585-275-5830

Richard G. Moore
Principal Investigator

North Carolina
Burlington

Cone Health Cancer Center at Alamance Regional

Janak Kantilal Choksi
Ph: 336-538-7725

Janak Kantilal Choksi
Principal Investigator

Chapel Hill

UNC Lineberger Comprehensive Cancer Center

Linda Van Le
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Linda Van Le
Principal Investigator

Ohio
Akron

Summa Akron City Hospital/Cooper Cancer Center

Stephen J. Andrews
Ph: 330-375-6101

Stephen J. Andrews
Principal Investigator

Cincinnati

University of Cincinnati/Barrett Cancer Center

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

Eric Lawrence Eisenhauer
Principal Investigator

Cleveland

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
Email: som_dcop@wright.edu

Howard M. Gross
Principal Investigator

Kettering

Kettering Medical Center

Howard M. Gross
Ph: 937-775-1350
Email: som_dcop@wright.edu

Howard M. Gross
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Robert S. Mannel
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Robert S. Mannel
Principal Investigator

Tulsa

Oklahoma Cancer Specialists and Research Institute-Tulsa

Robert S. Mannel
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Robert S. Mannel
Principal Investigator

Oregon
Portland

Providence Portland Medical Center

Benjamin Buckner Bridges
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Benjamin Buckner Bridges
Principal Investigator

Pennsylvania
Abington

Abington Memorial Hospital

Joel I. Sorosky
Ph: 215-481-2402

Joel I. Sorosky
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 Penn Hospital

Thomas Carl Krivak
Ph: 412-578-5000

Thomas Carl Krivak
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

Gaffney

Gibbs Cancer Center-Gaffney

David Griffin
Ph: 864-512-1000

David Griffin
Principal Investigator

Greenville

Saint Francis Hospital

David Griffin
Ph: 864-512-1000

David Griffin
Principal Investigator

Greer

Gibbs Cancer Center-Pelham

David Griffin
Ph: 864-512-1000

David Griffin
Principal Investigator

Spartanburg

Spartanburg Medical Center

David Griffin
Ph: 864-512-1000

David Griffin
Principal Investigator

Union

MGC Hematology Oncology-Union

David Griffin
Ph: 864-512-1000

David Griffin
Principal Investigator

South Dakota
Rapid City

Rapid City Regional Hospital

Michael O. Robinson
Ph: 605-716-3982
Email: research@rcrh.org

Michael O. Robinson
Principal Investigator

Texas
Austin

Texas Oncology - Central Austin Cancer Center

Michael A. Bookman
Ph: 520-269-3821

Michael A. Bookman
Principal Investigator

Texas Oncology - South Austin Cancer Center

Michael A. Bookman
Ph: 520-269-3821

Michael A. Bookman
Principal Investigator

Texas Oncology-Austin Midtown

Michael A. Bookman
Ph: 520-269-3821

Michael A. Bookman
Principal Investigator

Bedford

Texas Oncology Bedford

Michael A. Bookman
Ph: 520-269-3821

Michael A. Bookman
Principal Investigator

Dallas

Texas Oncology at Baylor Charles A Sammons Cancer Center

Michael A. Bookman
Ph: 520-269-3821

Michael A. Bookman
Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

David Scott Miller
Ph: 214-648-7097

David Scott Miller
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

The Methodist Hospital System

Aparna A. Kamat
Ph: 713-790-2700

Aparna A. Kamat
Principal Investigator

Odessa

West Texas Cancer Center

Michael A. Bookman
Ph: 520-269-3821

Michael A. Bookman
Principal Investigator

Sugar Land

Houston Methodist Sugar Land Hospital

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: 434-243-6322
Email: JME3D@hscmail.mcc.virginia.edu

Susan Carnall Modesitt
Principal Investigator

Richmond

Virginia Commonwealth University/Massey Cancer Center

Emma Charlotte Fields
Ph: 804-628-1939

Emma Charlotte Fields
Principal Investigator

Roanoke

Carilion Clinic Gynecological Oncology

Janet L. Osborne
Ph: 540-985-8510

Janet L. Osborne
Principal Investigator

Washington
Auburn

MultiCare Auburn Medical Center

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

Gig Harbor

MultiCare Gig Harbor Medical Park

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

Puyallup

MultiCare Good Samaritan Hospital

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

Tacoma

MultiCare Tacoma General Hospital

John A. Keech
Ph: 253-403-2394

John A. Keech
Principal Investigator

Wisconsin
Green Bay

Aurora BayCare Medical Center

Ali Mahdavi
Ph: 800-928-1103

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: 800-928-1103

Ali Mahdavi
Principal Investigator

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Ali Mahdavi
Ph: 800-928-1103

Ali Mahdavi
Principal Investigator

West Allis

Aurora West Allis Medical Center

Ali Mahdavi
Ph: 800-928-1103

Ali Mahdavi
Principal Investigator

Wyoming
Cheyenne

Cheyenne Regional Medical Center-West

Keren Sturtz
Ph: 303-777-2663
Email: ccrp@co-cancerresearch.org

Keren Sturtz
Principal Investigator

Cody

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
Hamilton

Juravinski Cancer Centre at Hamilton Health Sciences

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

Lorraine (Laurie) M. Elit
Principal Investigator

London

London Regional Cancer Program

David Paul D'Souza
Ph: 519-685-8600

David Paul D'Souza
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

McGill University Department of Oncology

Joanne Alfieri
Ph: 514-934-1934extn42953
Email: evelyn.ortega@muhc.mcgill.ca

Joanne Alfieri
Principal Investigator

The Research Institute of the McGill University Health Centre (MUHC)

Joanne Alfieri
Ph: 514-934-1934ext42953
Email: evelyn.ortega@muhc.mcgill.ca

Joanne Alfieri
Principal Investigator

Saskatchewan
Regina

Allan Blair Cancer Centre

Evgeny Sadikov
Ph: 306-766-2213

Evgeny Sadikov
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier 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.