Radiation Therapy with or without Cisplatin in Treating Patients with Recurrent Endometrial Cancer

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IITreatmentNot specifiedGOG-0238
NCI-2009-00603, CDR0000550975, NCT00492778

Trial Description

Summary

This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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 giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina.

SECONDARY OBJECTIVES:

I. To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma.

II. To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin.

III. To estimate the prognostic significance of the location (central pelvis versus vagina) and size of the recurrence, in addition to the prognostic significance in the salvage setting of the histological subtype, grade, patient age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy.

IV. To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population.

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

ARM I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy* or low-dose rate interstitial brachytherapy*.

ARM II: Patients undergo EBRT as in Arm I and receive cisplatin intravenously (IV) over 1-2 hours on days 1, 8, 15, 22, and 29. Patients then undergo brachytherapy* as in Arm I.

NOTE: *IMRT boost is allowed for patients who are not candidates for brachytherapy. IMRT may also be used for the entire course of therapy for the treatment of the whole pelvis and/or the boost in patients not undergoing brachytherapy. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

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:

Patients must have a biopsy with histologically confirmed diagnosis of recurrent endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic disease

Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1

Alkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)

Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry

Patients must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies

Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2

Absolute neutrophil count (ANC) >= 1,500/mm^3 , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 3.0) grade 1

Patients who have met the pre-entry requirements

Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)

Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)

Patients must have an estimated survival greater or equal to 3 months

Platelets >= 100,000/mm^3, equivalent to CTCAE v 3.0 grade 0-1

Patients must have no evidence of extrapelvic disease; complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease; this should include: computed tomography (CT) scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast performed using multi-detector CT and equal or less than 5 mm slice thickness; if the patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV gadolinium should be performed; a chest x-ray should be done first, and if abnormal, then a CT scan of the chest should be done

All patients must have undergone complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy for their uterine carcinoma

Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Primary surgical debulking before protocol therapy is permissible; this would include removal of gross symptomatic disease in the pelvis and/or vagina

Exenterative surgery is not permissible; patients with complete resection of gross recurrent disease are eligible

Patients may have received prior hormone therapy and/or systemic chemotherapy; such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present recurrent disease

Creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0; NOTE: if creatinine > ULN, creatinine clearance must be > 50 mL/min

Exclusion Criteria:

Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes

Patients with septicemia or severe infection

Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields

Patients who received chemotherapy directed at the present recurrence

Patients who have received previous vaginal, pelvic, or abdominal irradiation

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 who have circumstances that will not permit completion of this study or the required follow-up

Patients who have undergone complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT or MRI imaging, following resection

Patients with history of active collagen vascular disease

Patients with GOG performance grade of 3 or 4

Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within 6 months of registration

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • National Cancer Institute
Jonathan Michael Feddock, Principal Investigator

Trial Sites

U.S.A.

California
Auburn

Sutter Auburn Faith Hospital

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

John K. Chan
Principal Investigator

Sutter Cancer Centers Radiation Oncology Services-Auburn

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

John K. Chan
Principal Investigator

Berkeley

Alta Bates Summit Medical Center-Herrick Campus

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

John K. Chan
Principal Investigator

Burbank

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Alison Katherine Conlin
Ph: 503-215-6412

Alison Katherine Conlin
Principal Investigator

Burlingame

Mills - Peninsula Hospitals

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

John K. Chan
Principal Investigator

Cameron Park

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

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

John K. Chan
Principal Investigator

Castro Valley

Eden Hospital Medical Center

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

John K. Chan
Principal Investigator

Davis

Sutter Davis Hospital

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

John K. Chan
Principal Investigator

La Jolla

UC San Diego Moores Cancer Center

Higinia Rosa Cardenes Perera

Higinia Rosa Cardenes Perera
Principal Investigator

Los Angeles

Kaiser Permanente Los Angeles Medical Center

Scott E. Lentz
Ph: 626-564-3455

Scott E. Lentz
Principal Investigator

Modesto

Memorial Medical Center

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

John K. Chan
Principal Investigator

Mountain View

Palo Alto Medical Foundation-Camino Division

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

John K. Chan
Principal Investigator

Palo Alto Medical Foundation-Gynecologic Oncology

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

John K. Chan
Principal Investigator

Novato

Sutter Cancer Research Consortium

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

John K. Chan
Principal Investigator

Palo Alto

Palo Alto Medical Foundation Health Care

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

John K. Chan
Principal Investigator

Roseville

Sutter Cancer Centers Radiation Oncology Services-Roseville

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

John K. Chan
Principal Investigator

Sutter Roseville Medical Center

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

John K. Chan
Principal Investigator

Sacramento

Sutter General Hospital

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

John K. Chan
Principal Investigator

San Francisco

California Pacific Medical Center-Pacific Campus

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

John K. Chan
Principal Investigator

Santa Cruz

Palo Alto Medical Foundation-Santa Cruz

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

John K. Chan
Principal Investigator

Santa Rosa

Sutter Pacific Medical Foundation

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

John K. Chan
Principal Investigator

Sunnyvale

Palo Atlo Medical Foundation-Sunnyvale

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

John K. Chan
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

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

John K. Chan
Principal Investigator

Vallejo

Sutter Solano Medical Center/Cancer Center

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

John K. Chan
Principal Investigator

Connecticut
Hartford

Hartford Hospital

James S. Hoffman
Ph: 860-224-5660

James S. Hoffman
Principal Investigator

Saint Francis Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

New Britain

The Hospital of Central Connecticut

James S. Hoffman
Ph: 860-224-5660

James S. Hoffman
Principal Investigator

Delaware
Lewes

Beebe Medical Center

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

Newark

Christiana Care Health System-Christiana Hospital

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

Christiana Gynecologic Oncology LLC

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

Delaware Clinical and Laboratory Physicians PA

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

Helen F Graham Cancer Center

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

Medical Oncology Hematology Consultants PA

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

Regional Hematology and Oncology PA

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

Rehoboth Beach

Beebe Health Campus

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

Seaford

Nanticoke Memorial Hospital

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

Wilmington

Christiana Care Health System-Wilmington Hospital

Mark Eliot Borowsky
Ph: 302-733-6227

Mark Eliot Borowsky
Principal Investigator

District of Columbia
Washington

Sibley Memorial Hospital

Mildred R. Chernofsky
Ph: 202-243-2373

Mildred R. Chernofsky
Principal Investigator

Florida
Sarasota

Sarasota Memorial Hospital

James Vincent Fiorica
Ph: 941-917-2225

James Vincent Fiorica
Principal Investigator

Georgia
Atlanta

Northside Hospital

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

Guilherme Henrique C. Cantuaria
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

Memorial University Medical Center

James Joseph Burke
Ph: 912-350-8568

James Joseph Burke
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Illinois
Chicago

Northwestern University

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

Emily Berry
Principal Investigator

Evanston

NorthShore University HealthSystem-Evanston Hospital

Jean A. Hurteau
Ph: 847-570-2109

Jean A. Hurteau
Principal Investigator

Galesburg

Illinois CancerCare-Galesburg Cottage Plaza Office

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Hinsdale

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Sudarshan K. Sharma
Ph: 630-856-6757

Sudarshan K. Sharma
Principal Investigator

Moline

Garneau, Stewart C MD (UIA Investigator)

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Spector, David MD (UIA Investigator)

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Trinity Medical Center

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Warrenville

Cadence Cancer Center in Warrenville

LaToya J. Perry
Ph: 630-208-4563
Email: kevin.tomczyk@delnor.com

LaToya J. Perry
Principal Investigator

Iowa
Bettendorf

Constantinou, Costas L MD (UIA Investigator)

David Martens Spector
Ph: 309-779-4200

David Martens Spector
Principal Investigator

Iowa City

University of Iowa/Holden Comprehensive Cancer Center

David Paul Bender
Ph: 800-237-1225

David Paul Bender
Principal Investigator

Sioux City

Siouxland Regional Cancer Center

Donald B. Wender
Ph: 712-252-0088

Donald B. Wender
Principal Investigator

Kansas
Chanute

Cancer Center of Kansas - Chanute

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Dodge City

Cancer Center of Kansas - Dodge City

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

El Dorado

Cancer Center of Kansas - El Dorado

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Fort Scott

Cancer Center of Kansas - Fort Scott

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Independence

Cancer Center of Kansas-Independence

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Kingman

Cancer Center of Kansas-Kingman

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Lawrence

Lawrence Memorial Hospital

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Liberal

Cancer Center of Kansas-Liberal

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Newton

Cancer Center of Kansas - Newton

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Overland Park

Menorah Medical Center

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Saint Luke's South Hospital

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Parsons

Cancer Center of Kansas - Parsons

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Pratt

Cancer Center of Kansas - Pratt

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Salina

Cancer Center of Kansas - Salina

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wellington

Cancer Center of Kansas - Wellington

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wichita

Associates In Womens Health

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas - Main Office

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Cancer Center of Kansas-Wichita Medical Arts Tower

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Via Christi Regional Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Wesley Medical Center

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Winfield

Cancer Center of Kansas - Winfield

Shaker R. Dakhil
Ph: 316-262-4467

Shaker R. Dakhil
Principal Investigator

Kentucky
Edgewood

Saint Elizabeth Medical Center South

Jack B. Basil
Ph: 513-862-2230

Jack B. Basil
Principal Investigator

Louisiana
Baton Rouge

Woman's Hospital

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

Giles Fort
Principal Investigator

Maine
Portland

Maine Medical Center-Bramhall Campus

Christopher J. Darus
Ph: 207-885-7565

Christopher J. Darus
Principal Investigator

Scarborough

Maine Medical Center- Scarborough Campus

Christopher J. Darus
Ph: 207-885-7565

Christopher J. Darus
Principal Investigator

Maryland
Baltimore

Greater Baltimore Medical Center

Paul Celano
Ph: 443-849-3706

Paul Celano
Principal Investigator

Michigan
Ann Arbor

Saint Joseph Mercy Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Dearborn

Oakwood Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Wayne State University/Karmanos Cancer Institute

Robert Thomas Morris
Ph: 313-576-9363

Robert Thomas Morris
Principal Investigator

Farmington Hills

Weisberg Cancer Treatment Center

Robert Thomas Morris
Ph: 313-576-9363

Robert Thomas Morris
Principal Investigator

Flint

Genesys Hurley Cancer Institute

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Hurley Medical Center

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Jackson

Allegiance Health

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Kalamazoo

Borgess Medical Center

Raymond Sterling Lord
Ph: 269-373-7458

Raymond Sterling Lord
Principal Investigator

Bronson Methodist Hospital

Raymond Sterling Lord
Ph: 269-373-7458

Raymond Sterling Lord
Principal Investigator

West Michigan Cancer Center

Raymond Sterling Lord
Ph: 269-373-7458

Raymond Sterling Lord
Principal Investigator

Lansing

Sparrow Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Livonia

Saint Mary Mercy Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Pontiac

Saint Joseph Mercy Oakland

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Port Huron

Saint Joseph Mercy Port Huron

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Saginaw

Saint Mary's of Michigan

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Warren

Saint John Macomb-Oakland Hospital

Philip J. Stella
Ph: 734-712-4673

Philip J. Stella
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

James Tate Thigpen
Ph: 601-815-6700

James Tate Thigpen
Principal Investigator

Pascagoula

Singing River Hospital

James E. Clarkson
Ph: 228-809-5292

James E. Clarkson
Principal Investigator

Missouri
Columbia

University of Missouri - Ellis Fischel

Akm Mosharraf Hossain
Ph: 573-882-7440

Akm Mosharraf Hossain
Principal Investigator

Independence

Centerpoint Medical Center LLC

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Kansas City

Heartland Hematology and Oncology Associates Incorporated

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Research Medical Center

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Saint Luke's Hospital of Kansas City

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Lee's Summit

Saint Luke's East - Lee's Summit

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Liberty

Liberty Radiation Oncology Center

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

Saint Joseph

Heartland Regional Medical Center

Rakesh Gaur
Ph: 816-932-2677
Email: SLCIResearch1@saint-lukes.org

Rakesh Gaur
Principal Investigator

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

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
Henderson

21st Century Oncology - Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Southeast Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas Cancer Center-Henderson

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas

21st Century Oncology

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

21st Century Oncology - Fort Apache

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

21st Century Oncology - Vegas Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Fort Apache

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Shadow

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer and Blood Specialists-Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Cancer Therapy and Integrative Medicine

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Central Valley

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada - Northwest

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Comprehensive Cancer Centers of Nevada-Summerlin

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-San Martin

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Las Vegas Cancer Center-Medical Center

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Central

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Radiation Oncology Centers of Nevada Southeast

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

University Medical Center of Southern Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

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

Lebanon

Dartmouth Hitchcock Medical Center

Leslie R. DeMars
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Leslie R. DeMars
Principal Investigator

New Jersey
Camden

Cooper Hospital University Medical Center

David Philip Warshal
Ph: 856-325-6757

David Philip Warshal
Principal Investigator

Mount Holly

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Randolph Bruce Deger
Ph: 888-847-8823

Randolph Bruce Deger
Principal Investigator

Paramus

The Valley Hospital-Luckow Pavilion

Noah A. Goldman
Ph: 201-634-5792

Noah A. Goldman
Principal Investigator

Phillipsburg

The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery

David Foster Silver
Ph: 718-765-2500

David Foster Silver
Principal Investigator

Voorhees

MD Anderson Cancer Center at Cooper-Voorhees

David Philip Warshal
Ph: 856-325-6757

David Philip Warshal
Principal Investigator

Virtua West Jersey Hospital Voorhees

Randolph Bruce Deger
Ph: 888-847-8823

Randolph Bruce Deger
Principal Investigator

Westwood

Oncology Hematology and Internal Medicine

Noah A. Goldman
Ph: 201-634-5792

Noah A. Goldman
Principal Investigator

New Mexico
Albuquerque

University of New Mexico

Higinia Rosa Cardenes Perera

Higinia Rosa Cardenes Perera
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

Manhasset

North Shore University Hospital

Veena Susan John
Ph: 516-562-3467

Veena Susan John
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

Stony Brook

Stony Brook University Medical Center

Michael L. Pearl
Ph: 800-862-2215

Michael L. Pearl
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Mary Jadhon Cunningham
Ph: 315-464-5476

Mary Jadhon Cunningham
Principal Investigator

North Carolina
Charlotte

Novant Health Presbyterian Medical Center

John Matthew McDonald
Ph: 704-384-5369

John Matthew McDonald
Principal Investigator

Clinton

Southeastern Medical Oncology Center-Clinton

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Goldsboro

Southeastern Medical Oncology Center-Goldsboro

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Wayne Memorial Hospital

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Jacksonville

Southeastern Medical Oncology Center-Jacksonville

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Wilson

Southeastern Medical Oncology Center-Wilson

James N. Atkins
Ph: 919-580-0000

James N. Atkins
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Samuel Smith Lentz
Ph: 336-713-6771

Samuel Smith Lentz
Principal Investigator

Ohio
Beachwood

UHHS-Chagrin Highlands Medical Center

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
Principal Investigator

Belpre

Strecker Cancer Center-Belpre

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Canton

Aultman Health Foundation

Michael P. Hopkins
Ph: 330-363-6891

Michael P. Hopkins
Principal Investigator

Chillicothe

Adena Regional Medical Center

John Philip Kuebler
Ph: 614-566-3275

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

University of Cincinnati

Thomas J. A. Reid
Ph: 937-298-3399

Thomas J. A. Reid
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: 614-566-3275

John Philip Kuebler
Principal Investigator

Doctors Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Grant Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Mount Carmel East Hospital

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: 614-566-3275

John Philip Kuebler
Principal Investigator

Ohio State University Comprehensive Cancer Center

Higinia Rosa Cardenes Perera

Higinia Rosa Cardenes Perera
Principal Investigator

Riverside Methodist Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

The Mark H Zangmeister Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Delaware

Delaware Health Center-Grady Cancer Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Delaware Radiation Oncology

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Grady Memorial Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Lancaster

Fairfield Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Marietta

Marietta Memorial Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Marion

OneHealth Marion General 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

Ireland Cancer Center Landerbrook Health Center

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
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: 614-566-3275

John Philip Kuebler
Principal Investigator

Newark

Licking Memorial Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Newark Radiation Oncology

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Portsmouth

Southern Ohio Medical Center

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Springfield

Springfield Regional Medical Center

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

John Philip Kuebler
Principal Investigator

Sylvania

Flower Hospital

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Toledo

Toledo Community Hospital Oncology Program CCOP

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

University of Toledo

Rex B. Mowat
Ph: 800-444-3561

Rex B. Mowat
Principal Investigator

Wadsworth

University Hospitals Sharon Health Center

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
Principal Investigator

Westerville

Saint Ann's Hospital

John Philip Kuebler
Ph: 614-566-3275

John Philip Kuebler
Principal Investigator

Westlake

UHHS-Westlake Medical Center

Steven E. Waggoner
Ph: 800-641-2422

Steven E. Waggoner
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

Danville

Geisinger Medical Center

Radhika P. Gogoi
Ph: 570-271-5251

Radhika P. Gogoi
Principal Investigator

Gettysburg

Adams Cancer Center

Mark A. Miller
Ph: 877-441-7957

Mark A. Miller
Principal Investigator

Hanover

Cherry Tree Cancer Center

Mark A. Miller
Ph: 877-441-7957

Mark A. Miller
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

Wynnewood

Lankenau Medical Center

Paul B. Gilman
Ph: 484-476-2649
Email: wellenbachj@mlhs.org

Paul B. Gilman
Principal Investigator

York

WellSpan Health-York Cancer Center

Mark A. Miller
Ph: 877-441-7957

Mark A. Miller
Principal Investigator

WellSpan Health-York Hospital

Mark A. Miller
Ph: 877-441-7957

Mark A. Miller
Principal Investigator

South Carolina
Easley

Greenville Health System Cancer Institute-Easley

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

Greenville

Greenville Health System Cancer Institute-Andrews

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

Greenville Health System Cancer Institute-Butternut

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

Greenville Health System Cancer Institute-Eastside

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

Greenville Health System Cancer Institute-Faris

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

Greenville Memorial Hospital

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

Greer

Greenville Health System Cancer Institute-Greer

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

Seneca

Greenville Health System Cancer Institute-Seneca

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

Spartanburg

Greenville Health System Cancer Institute-Spartanburg

Jeffrey W. Elder
Ph: 864-679-3966

Jeffrey W. Elder
Principal Investigator

South Dakota
Sioux Falls

Avera Cancer Institute

Luis A. Rojas-Espaillat
Ph: 800-657-4377
Email: Jan.Healy@avera.org

Luis A. Rojas-Espaillat
Principal Investigator

Tennessee
Knoxville

University of Tennessee - Knoxville

Larry Clinton Kilgore
Ph: 865-544-9773

Larry Clinton Kilgore
Principal Investigator

Texas
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

Houston

The Methodist Hospital System

Daniel E. Lehane
Ph: 713-790-2700

Daniel E. Lehane
Principal Investigator

Sugar Land

Houston Methodist Sugar Land Hospital

Daniel E. Lehane
Ph: 713-790-2700

Daniel E. Lehane
Principal Investigator

Utah
Salt Lake City

Huntsman Cancer Institute/University of Utah

Andrew Patrick Soisson
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Andrew Patrick Soisson
Principal Investigator

Vermont
Burlington

University of Vermont Medical Center

Cheung Wong
Ph: 802-656-8990

Cheung Wong
Principal Investigator

Wisconsin
Green Bay

Green Bay Oncology at Saint Vincent Hospital

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Green Bay Oncology Limited at Saint Mary's Hospital

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Saint Mary's Hospital

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

Saint Vincent Hospital

Jonathan Edward Tammela
Ph: 920-433-8889

Jonathan Edward Tammela
Principal Investigator

La Crosse

Gundersen Lutheran Medical Center

Kurt Oettel
Ph: 608-775-2385
Email: cancerctr@gundluth.org

Kurt Oettel
Principal Investigator

Madison

University of Wisconsin Hospital and Clinics

David M. Kushner
Ph: 877-405-6866

David M. Kushner
Principal Investigator

Milwaukee

Aurora Saint Luke's Medical Center

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
Sheridan

Welch Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00492778

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.