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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCI, OtherGOG-0275
NCI-2012-00250, CDR0000725211, 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 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 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 human chorionic gonadotropin (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 times institutional normal
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 times institutional normal
  • Alkaline phosphatase =< 3 times institutional normal
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • No patients with non-gestational choriocarcinoma
  • No 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
  • No patients who have received prior pelvic radiation
  • No patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
  • No 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
  • No patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
  • No patients who wish to breast-feed during treatment

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Julian SchinkPrincipal Investigator

Trial Sites

U.S.A.
Arizona
  Phoenix
 GOG of Arizona, PC
 Julian C. Schink Ph: 312-472-4684
  Email: jschink@nmff.org
 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
  Email: uchealthnews@uc.edu
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
  Email: julie-traylor@ouhsc.edu
  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
  Email: julie-traylor@ouhsc.edu
  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
 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
Kentucky
  Edgewood
 St. Elizabeth Medical Center
 James C Pavelka Ph: 513-862-2230
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
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Gilbert D Padula Ph: 616-685-5225
 Lacks Cancer Center at Saint Mary's Health Care
 Gilbert D Padula Ph: 616-685-5225
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Sunil Nagpal Ph: 269-373-7458
  Muskegon
 Mercy General Health Partners
 Gilbert D Padula Ph: 616-685-5225
  Niles
 Lakeland Hospital - Niles
 Michael W. Method Ph: 574-237-1328
  Reed City
 Spectrum Health Reed City Hospital
 Gilbert D Padula Ph: 616-685-5225
  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
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
 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
 CCOP - Metro-Minnesota
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 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
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
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
  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: 866-627-7616
  Email: osu@emergingmed.com
 CCOP - Columbus
 J. Philip Kuebler Ph: 614-566-3275
 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
 Oklahoma University Cancer Institute
 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
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Radhika P Gogoi Ph: 570-271-5251
  Email: wellenbachj@mlhs.org
  Hazleton
 Geisinger Hazleton Cancer Center
 Radhika P Gogoi Ph: 570-271-5251
  Email: wellenbachj@mlhs.org
  Philadelphia
 Temple Cancer Center at Temple University Hospital
 Enrique Hernandez Ph: 215-728-2983
  Pittsburgh
 UPMC Cancer Centers
 Alexander B Olawaiye Ph: 412-647-2811
  State College
 Geisinger Medical Group - Scenery Park
 Radhika P Gogoi Ph: 570-271-5251
  Email: wellenbachj@mlhs.org
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Radhika P Gogoi Ph: 570-271-5251
  Email: wellenbachj@mlhs.org
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: 412-647-2811
Wisconsin
  Burlington
 Aurora Cancer Care-Burlington
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Elkhorn
 Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Grafton
 Aurora Cancer Care-Grafton
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Green Bay
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Kenosha
 Oncology Alliance - Kenosha South
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Marinette
 Vince Lombardi Cancer Clinic - Marinette
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Menomonee Falls
 Aurora Advanced Healthcare Inc-Menomonee Falls
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Milwaukee
 Aurora Cancer Care-Milwaukee
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
 Aurora Sinai Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
 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
  Email: ucstudy@uci.edu
  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
  Email: ucstudy@uci.edu
  Racine
 Aurora Health Center - Racine
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Sheboygan
 Vince Lombardi Cancer Clinic - Sheboygan
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Summit
 Aurora Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Waukesha
 Aurora Cancer Care-Waukesha
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Wauwatosa
 Oncology Alliance, SC - Milwaukee - West
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
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
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
 Gangnam Severance Hospital
 Jae-Hoon Kim
  Email: clinical.trial@bms.com
 Korea Cancer Center Hospital
 Moon-Hong Kim Ph: 011-82-02-9702-114
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 Identifer NCT01535053
ClinicalTrials.gov processed this data on August 01, 2014

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.

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