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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCI, OtherGOG-0275
NCI-2012-00250, CDR0000725211, U10CA180868, U10CA027469, NCT01535053

Trial Description

Summary

This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

Further Study Information

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

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

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

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

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

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

ARM II: Patients receive dactinomycin IV over 15 minutes on day 1.

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

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

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

Eligibility Criteria

Inclusion Criteria:

  • Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:
  • Post molar GTN
  • For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:
  • A < 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3weeks (> 50 mIU/ml minimum) OR
  • A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml minimum) OR
  • A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum)
  • Choriocarcinoma
  • Histologically proven non-metastatic choriocarcinoma OR
  • Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung
  • World Health Organization (WHO) risk score 0-6
  • Patients must be willing to practice effective contraception for the duration of the study
  • White blood cell count (WBC) >= 3,000 cells/mcL
  • Granulocytes >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Creatinine =< 2.0 mg/dcL
  • Bilirubin =< 1.5 x institutional normal
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x institutional normal
  • Alkaline phosphatase =< 3 x institutional normal
  • Patients who have met the pre-entry requirements
  • Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

  • Patients who do not have GTN
  • Patients with non-gestational choriocarcinoma
  • Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study
  • Patients who have received prior pelvic radiation
  • Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
  • Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4
  • 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 whose circumstances at the time of study entry do not permit completion of the study or required follow-up
  • Patients who wish to breast-feed during treatment

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

  • National Cancer Institute
Julian Schink, Principal Investigator

Trial Sites

U.S.A.

Arizona
Phoenix

St. Joseph's Hospital and Medical Center

John H Farley
Ph: 877-602-4111

California
La Jolla

Rebecca and John Moores UCSD Cancer Center

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

Los Angeles

Kaiser Permanente Medical Center - Los Angeles

Scott E. Lentz
Ph: 626-564-3455

Connecticut
Hartford

Helen and Harry Gray Cancer Center at Hartford Hospital

James S. Hoffman
Ph: 860-224-5660

New Britain

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

James S. Hoffman
Ph: 860-224-5660

Georgia
Augusta

Medical College of Georgia Cancer Center

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

Decatur

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Cyril O Spann
Ph: 404-501-3279

Gainesville

Northeast Georgia Medical Center

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

Savannah

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

James J Burke
Ph: 912-350-8568

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

William Edward Richards
Ph: 800-622-6877

Idaho
Post Falls

Kootenai Cancer Center - Post Falls

Benjamin Thomas Marchello
Ph: 800-648-6274

Illinois
Aurora

Rush-Copley Cancer Care Center

Kendrith M. Rowland
Ph: 800-446-5532

Chicago

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

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

University of Chicago Cancer Research Center

Meaghan E Tenney
Ph: 773-834-7424

Danville

Carle on Vermilion

Kendrith M. Rowland
Ph: 800-446-5532

Effingham

Carle Physician Group-Effingham

Kendrith M. Rowland
Ph: 800-446-5532

Hinsdale

Gynecologic Oncology

Sudarshan K. Sharma
Ph: 630-856-6757

Mattoon

Carle Physician Group-Mattoon/Charleston

Kendrith M. Rowland
Ph: 800-446-5532

New Lennox

Silver Cross Hospital

Meaghan E Tenney
Ph: 773-834-7424

Urbana

Carle Cancer Center at Carle Foundation Hospital

Kendrith M. Rowland
Ph: 800-446-5532

Kendrith M. Rowland
Ph: 800-446-5532

Yorkville

Rush-Copley Healthcare Center

Kendrith M. Rowland
Ph: 800-446-5532

Indiana
Elkhart

Elkhart Clinic, LLC

Michael W. Method
Ph: 574-237-1328

Michiana Hematology-Oncology, PC - Elkhart

Michael W. Method
Ph: 574-237-1328

Indianapolis

St. Vincent Oncology Center

Gregory P. Sutton
Ph: 317-338-2194

Michigan City

Saint Anthony Memorial Health Centers

Kendrith M. Rowland
Ph: 800-446-5532

Woodland Cancer Care Center

Kendrith M. Rowland
Ph: 800-446-5532

Mishawaka

Michiana Hematology-Oncology, PC - Mishawaka

Michael W. Method
Ph: 574-237-1328

Saint Joseph's Medical Center

Michael W. Method
Ph: 574-237-1328

Plymouth

Michiana Hematology Oncology PC - Plymouth

Michael W. Method
Ph: 574-237-1328

South Bend

CCOP - Northern Indiana CR Consortium

Michael W. Method
Ph: 574-237-1328

Memorial Hospital of South Bend

Michael W. Method
Ph: 574-237-1328

Michiana Hematology-Oncology, PC - South Bend

Michael W. Method
Ph: 574-237-1328

Westville

Michiana Hematology Oncology-PC Westville

Michael W. Method
Ph: 574-237-1328

Iowa
Sioux City

Siouxland Hematology-Oncology Associates, LLP

Donald Bruce Wender
Ph: 712-252-0088

Maine
Portland

Maine Medical Center - Bramhall Campus

Christopher J Darus
Ph: 207-885-7565

Scarborough

Maine Medical Center- Scarborough Campus

Christopher J Darus
Ph: 207-885-7565

Maryland
Bethesda

National Naval Medical Center

Michael P Stany
Ph: 301-319-2100

Massachusetts
Boston

Dana-Farber/Brigham and Women's Cancer Center

Neil S Horowitz
Ph: 617-724-5200

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Neil S Horowitz
Ph: 617-724-5200

Michigan
Battle Creek

Battle Creek Health System Cancer Care Center

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

Grand Rapids

Butterworth Hospital at Spectrum Health

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

Lacks Cancer Center at Saint Mary's Health Care

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

Kalamazoo

West Michigan Cancer Center

Sunil Nagpal
Ph: 269-373-7458

Muskegon

Mercy General Health Partners

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

Reed City

Spectrum Health Reed City Hospital

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

Saint Joseph

Lakeside Cancer Specialists, PLLC

Michael W. Method
Ph: 574-237-1328

St. Joseph

Lakeland Regional Cancer Care Center - St. Joseph

Michael W. Method
Ph: 574-237-1328

Traverse City

Munson Medical Center

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

Minnesota
Burnsville

Fairview Ridges Hospital

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

Coon Rapids

Mercy and Unity Cancer Center at Mercy Hospital

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

Edina

Fairview Southdale Hospital

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

Fridley

Mercy and Unity Cancer Center at Unity Hospital

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

Hutchinson

Hutchinson Area Health Care

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

Maplewood

HealthEast Cancer Care at St. John's Hospital

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

Minnesota Oncology - Maplewood

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

Minneapolis

Health Partners Inc

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

Hennepin County Medical Center - Minneapolis

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

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

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

New Ulm

New Ulm Medical Center

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

Robbinsdale

Humphrey Cancer Center at North Memorial Outpatient Center

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

Saint Louis Park

Park Nicollet Cancer Center

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

Saint Paul

Regions Hospital Cancer Care Center

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

United Hospital

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

Shakopee

St. Francis Cancer Center at St. Francis Medical Center

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

Stillwater

Lakeview Hospital

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

Waconia

Ridgeview Medical Center

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

Willmar

Willmar Cancer Center at Rice Memorial Hospital

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

Woodbury

Minnesota Oncology - Woodbury

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

Missouri
Saint Louis

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

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

Springfield

Hulston Cancer Center at Cox Medical Center South

Jay W Carlson
Ph: 800-821-7532

St. John's Regional Health Center

Jay W Carlson
Ph: 800-821-7532

Montana
Billings

Billings Clinic Cancer Center - 801 N 29th Street

Benjamin Thomas Marchello
Ph: 800-648-6274

CCOP - Montana Cancer Consortium

Benjamin Thomas Marchello
Ph: 800-648-6274

St. Vincent Healthcare Cancer Care Services

Benjamin Thomas Marchello
Ph: 800-648-6274

Bozeman

Bozeman Deaconess Cancer Center

Benjamin Thomas Marchello
Ph: 800-648-6274

Butte

St. James Healthcare Cancer Care

Benjamin Thomas Marchello
Ph: 800-648-6274

Great Falls

Benefis Sletten Cancer Institute

Benjamin Thomas Marchello
Ph: 800-648-6274

Helena

St. Peter's Hospital

Benjamin Thomas Marchello
Ph: 800-648-6274

Kalispell

Kalispell Regional Medical Center

Benjamin Thomas Marchello
Ph: 800-648-6274

Missoula

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Benjamin Thomas Marchello
Ph: 800-648-6274

Nevada
Las Vegas

Women's Cancer Center - La Canada

Nick M. Spirtos
Ph: 702-851-4672

New York
Brooklyn

SUNY Downstate Medical Center

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

New York

Memorial Sloan-Kettering Cancer Center

Elizabeth L Jewell
Ph: 212-639-7202

North Carolina
Winston-Salem

Wake Forest University Comprehensive Cancer Center

Samuel S. Lentz
Ph: 336-713-6771

Ohio
Akron

Summa Center for Cancer Care at Akron City Hospital

Vivian von Gruenigen
Ph: 330-375-6101

Belpre

Strecker Cancer Center-Belpre

J. Philip Kuebler
Ph: 614-566-3275

Chillicothe

Adena Regional Medical Center

J. Philip Kuebler
Ph: 614-566-3275

Cincinnati

Bethesda North Hospital

James C Pavelka
Ph: 513-862-2230

Good Samaritan Hospital Cancer Treatment Center

James C Pavelka
Ph: 513-862-2230

Cleveland

Case Comprehensive Cancer Center

Steven E. Waggoner
Ph: 800-641-2422

Cleveland Clinic Cancer Center at Fairview Hospital

Peter Graham Rose
Ph: 866-223-8100

Cleveland Clinic Taussig Cancer Center

Peter Graham Rose
Ph: 866-223-8100

Columbus

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

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

Columbus Oncology Associates, Incorporated

J. Philip Kuebler
Ph: 614-566-3275

Doctors Hospital at Ohio Health

J. Philip Kuebler
Ph: 614-566-3275

Grant Medical Center Cancer Care

J. Philip Kuebler
Ph: 614-566-3275

Mount Carmel Health - West Hospital

J. Philip Kuebler
Ph: 614-566-3275

Riverside Methodist Hospital Cancer Care

J. Philip Kuebler
Ph: 614-566-3275

Zangmeister Center

J. Philip Kuebler
Ph: 614-566-3275

Delaware

Delaware Health Center

J. Philip Kuebler
Ph: 614-566-3275

Delaware Radiation Oncology

J. Philip Kuebler
Ph: 614-566-3275

Grady Memorial Hospital

J. Philip Kuebler
Ph: 614-566-3275

Lancaster

Fairfield Medical Center

J. Philip Kuebler
Ph: 614-566-3275

Marietta

Strecker Cancer Center at Marietta Memorial Hospital

J. Philip Kuebler
Ph: 614-566-3275

Mayfield Heights

Hillcrest Cancer Center at Hillcrest Hospital

Peter Graham Rose
Ph: 866-223-8100

Mentor

Lake/University Ireland Cancer Center

Steven E. Waggoner
Ph: 800-641-2422

Mount Vernon

Knox Community Hospital

J. Philip Kuebler
Ph: 614-566-3275

Newark

Licking Memorial Cancer Care Program at Licking Memorial Hospital

J. Philip Kuebler
Ph: 614-566-3275

Newark Radiation Oncology

J. Philip Kuebler
Ph: 614-566-3275

Portsmouth

Southern Ohio Medical Center Cancer Center

J. Philip Kuebler
Ph: 614-566-3275

Springfield

Community Hospital of Springfield and Clark County

J. Philip Kuebler
Ph: 614-566-3275

Westerville

Mount Carmel St. Ann's Cancer Center

J. Philip Kuebler
Ph: 614-566-3275

Zanesville

Genesis - Good Samaritan Hospital

J. Philip Kuebler
Ph: 614-566-3275

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

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

Tulsa

Cancer Care Associates-Yale

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

Pennsylvania
Abington

Rosenfeld Cancer Center at Abington Memorial Hospital

Parviz Hanjani
Ph: 215-481-2402

Beaver

UPMC Cancer Center at Beaver Medical Center

Alexander B Olawaiye
Ph: 412-647-2811

Clairton

UPMC Cancer Center at Jefferson Regional Medical Center

Alexander B Olawaiye
Ph: 412-647-2811

Danville

Geisinger Cancer Institute at Geisinger Health

Radhika P Gogoi
Ph: 570-271-5251

Greensburg

UPMC Cancer Center - Arnold Palmer Pavilion

Alexander B Olawaiye
Ph: 412-647-2811

Hazleton

Geisinger Hazleton Cancer Center

Radhika P Gogoi
Ph: 570-271-5251

Johnstown

UPMC Cancer Center at the John P. Murtha Pavilion

Alexander B Olawaiye
Ph: 412-647-2811

McKeesport

UPMC Cancer Center at UPMC McKeesport

Alexander B Olawaiye
Ph: 412-647-2811

Moon Township

UPMC - Moon

Alexander B Olawaiye
Ph: 412-647-2811

Philadelphia

Temple Cancer Center at Temple University Hospital

Enrique Hernandez
Ph: 215-728-2983

Pittsburgh

St. Clair Memorial Hospital Cancer Center

Alexander B Olawaiye
Ph: 412-647-2811

UPMC - Shadyside

Alexander B Olawaiye
Ph: 412-647-2811

UPMC Cancer Center at Magee-Womens Hospital

Alexander B Olawaiye
Ph: 412-647-2811

UPMC Cancer Center at UPMC Passavant

Alexander B Olawaiye
Ph: 412-647-2811

UPMC Cancer Center at UPMC Presbyterian

Alexander B Olawaiye
Ph: 412-647-2811

UPMC Cancer Center at UPMC St. Margaret

Alexander B Olawaiye
Ph: 412-647-2811

UPMC Cancer Centers

Alexander B Olawaiye
Ph: 412-647-2811

Seneca

UPMC Cancer Center at UPMC Northwest

Alexander B Olawaiye
Ph: 412-647-2811

State College

Geisinger Medical Group - Scenery Park

Radhika P Gogoi
Ph: 570-271-5251

Uniontown

UPMC Cancer Center - Uniontown

Alexander B Olawaiye
Ph: 412-647-2811

Washington

Washington Hospital Cancer Center

Alexander B Olawaiye
Ph: 412-647-2811

West Reading

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

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

Wilkes-Barre

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Radhika P Gogoi
Ph: 570-271-5251

Rhode Island
Providence

Women and Infants Hospital of Rhode Island

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

Tennessee
Knoxville

U.T. Medical Center Cancer Institute

Larry C Kilgore
Ph: 865-544-9773

Texas
Austin

University Medical Center Brackenridge

Mark A Crozier
Ph: 512-324-7991

Dallas

Parkland Memorial Hospital

David Scott Miller
Ph: 214-648-7097

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

David Scott Miller
Ph: 214-648-7097

West Virginia
Morgantown

Monongalia General Hospital

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

Wisconsin
Burlington

Aurora Cancer Care-Burlington

Ali Mahdavi
Ph: 414-649-5717

Elkhorn

Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn

Ali Mahdavi
Ph: 414-649-5717

Grafton

Aurora Cancer Care-Grafton

Ali Mahdavi
Ph: 414-649-5717

Green Bay

Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

Ali Mahdavi
Ph: 414-649-5717

Kenosha

Oncology Alliance - Kenosha South

Ali Mahdavi
Ph: 414-649-5717

Marinette

Vince Lombardi Cancer Clinic - Marinette

Ali Mahdavi
Ph: 414-649-5717

Menomonee Falls

Aurora Advanced Healthcare Inc-Menomonee Falls

Ali Mahdavi
Ph: 414-649-5717

Milwaukee

Aurora Cancer Care-Milwaukee

Ali Mahdavi
Ph: 414-649-5717

Aurora Sinai Medical Center

Ali Mahdavi
Ph: 414-649-5717

Oncology Alliance, SC - Milwaukee - South

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

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Ali Mahdavi
Ph: 414-649-5717

New Richmond

Cancer Center of Western Wisconsin

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

Oshkosh

Vince Lombardi Cancer Clinic - Oshkosh

Ali Mahdavi
Ph: 414-649-5717

Racine

Aurora Health Center - Racine

Ali Mahdavi
Ph: 414-649-5717

Sheboygan

Vince Lombardi Cancer Clinic - Sheboygan

Ali Mahdavi
Ph: 414-649-5717

Summit

Aurora Medical Center

Ali Mahdavi
Ph: 414-649-5717

Two Rivers

Vince Lombardi Cancer Clinic - Two Rivers

Ali Mahdavi
Ph: 414-649-5717

Waukesha

Aurora Cancer Care-Waukesha

Ali Mahdavi
Ph: 414-649-5717

Wauwatosa

Oncology Alliance, SC - Milwaukee - West

Ali Mahdavi
Ph: 414-649-5717

West Allis

Aurora Women's Pavilion of West Allis Memorial Hospital

Ali Mahdavi
Ph: 414-649-5717

Wyoming
Sheridan

Welch Cancer Center at Sheridan Memorial Hospital

Benjamin Thomas Marchello
Ph: 800-648-6274

Canada

Ontario
Toronto

Odette Cancer Centre at Sunnybrook

Allan Covens
Ph: 416-480-5000

Japan

Kagoshima City, Kagoshima

Kagoshima City Hospital

Toshiaki Nakamura
Ph: 011 81 099 224 2101

Osaka, Osaka

Kinki University School of Medicine

Masaki Mandai
Ph: 072-366-0221

Saitama

Saitama Medical University International Medical Center

Keiichi Fujiwara
Ph: 81-49-276-2028

Tottori

Tottori University Hospital

Hiroaki Itamochi
Ph: 0857-31-5007

Aoba-ku
Sendai

Tohoku University Graduate School of Medicine

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

Hiroshima
Kure

National Hospital Organization - Medical Center of Kure

Takashi Sawasaki
Ph: (0823) 22-3111

Hokkaido
Sapporo

Hokkaido University Hospital

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

Niigata
Niigata City

Niigata University Medical and Dental Hospital

Takayuki Enomoto
Ph: 81-025-223-6161

Okinawa
Nakagami-gun

Graduate School of Medical Science at the University of Ryukyu

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

Republic of Korea

Seoul

Asan Medical Center - University of Ulsan College of Medicine

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

Seoul National University Hospital

Hyun H Chung
Ph: 011-82-760-2384

KOREA
Seoul

Catholic University of Korea College of Medicine

Keun H Lee
Ph: 2258-5745-6

Samsung Medical Center

Jeong-Won Lee
Ph: 011-82-1599-3114

Kyeonggi-do
Seongnam City

Seoul National University Bundang Hospital

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

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01535053
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.