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

PHASE3CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

June 18, 2012

Primary Completion Date

May 31, 2018

Study Completion Date

July 17, 2020

Conditions
ChoriocarcinomaFIGO Stage I Gestational Trophoblastic TumorFIGO Stage II Gestational Trophoblastic TumorFIGO Stage III Gestational Trophoblastic TumorHydatidiform Mole
Interventions
BIOLOGICAL

Dactinomycin

Given IV

DRUG

Leucovorin Calcium

Given PO

DRUG

Methotrexate

Given IV and IM

OTHER

Quality-of-Life Assessment

Ancillary studies

Trial Locations (289)

737

Kure National Hospital, Kure

10065

Memorial Sloan Kettering Cancer Center, New York

11203

State University of New York Downstate Medical Center, Brooklyn

15009

UPMC-Heritage Valley Health System Beaver, Beaver

15108

UPMC-Coraopolis/Heritage Valley Radiation Oncology, Moon Township

15132

UPMC Cancer Center at UPMC McKeesport, McKeesport

15213

UPMC-Magee Womens Hospital, Pittsburgh

UPMC-Presbyterian Hospital, Pittsburgh

15215

UPMC-Saint Margaret, Pittsburgh

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

UPMC-Shadyside Hospital, Pittsburgh

15236

UPMC Jefferson Regional Radiation Oncology, Pittsburgh

15237

UPMC-Passavant Hospital, Pittsburgh

15243

UPMC-Saint Clair Hospital Cancer Center, Pittsburgh

15301

UPMC Washington Hospital Radiation Oncology, Washington

15401

UPMC Uniontown Hospital Radiation Oncology, Uniontown

15601

UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg

15901

UPMC-Johnstown/John P. Murtha Regional Cancer Center, Johnstown

16346

UPMC Cancer Center at UPMC Northwest, Seneca

16801

Geisinger Medical Group, State College

17822

Geisinger Medical Center, Danville

18201

Geisinger Medical Center-Cancer Center Hazleton, Hazleton

18711

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

19001

Jefferson Abington Hospital, Abington

19140

Temple University Hospital, Philadelphia

19611

Reading Hospital, West Reading

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

26505

Monongalia Hospital, Morgantown

27157

Wake Forest University Health Sciences, Winston-Salem

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

29601

Saint Francis Hospital, Greenville

29607

Saint Francis Cancer Center, Greenville

30033

Dekalb Medical Center, Decatur

30041

Northside Hospital-Forsyth, Cumming

30342

Northside Hospital, Atlanta

30501

Northeast Georgia Medical Center-Gainesville, Gainesville

30912

Augusta University Medical Center, Augusta

31404

Low Country Cancer Care, Savannah

Memorial Health University Medical Center, Savannah

Summit Cancer Care-Memorial, Savannah

31405

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah

37920

University of Tennessee - Knoxville, Knoxville

41017

Saint Elizabeth Healthcare Edgewood, Edgewood

43015

Delaware Health Center-Grady Cancer Center, Delaware

Delaware Radiation Oncology, Delaware

Grady Memorial Hospital, Delaware

43050

Knox Community Hospital, Mount Vernon

43055

Licking Memorial Hospital, Newark

Newark Radiation Oncology, Newark

43081

Saint Ann's Hospital, Westerville

43130

Fairfield Medical Center, Lancaster

Lancaster Radiation Oncology, Lancaster

43210

Ohio State University Comprehensive Cancer Center, Columbus

43214

Columbus Oncology and Hematology Associates Inc, Columbus

Riverside Methodist Hospital, Columbus

43215

Columbus NCI Community Oncology Research Program, Columbus

Grant Medical Center, Columbus

43219

The Mark H Zangmeister Center, Columbus

43222

Mount Carmel Health Center West, Columbus

43228

Doctors Hospital, Columbus

43560

ProMedica Flower Hospital, Sylvania

43701

Genesis Healthcare System Cancer Care Center, Zanesville

44060

UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor

44106

Case Western Reserve University, Cleveland

44111

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland

44124

Hillcrest Hospital Cancer Center, Mayfield Heights

44195

Cleveland Clinic Foundation, Cleveland

44304

Summa Health System - Akron Campus, Akron

45220

Good Samaritan Hospital - Cincinnati, Cincinnati

45242

Bethesda North Hospital, Cincinnati

45505

Springfield Regional Medical Center, Springfield

45601

Adena Regional Medical Center, Chillicothe

45662

Southern Ohio Medical Center, Portsmouth

45714

Strecker Cancer Center-Belpre, Belpre

45750

Marietta Memorial Hospital, Marietta

46260

Saint Vincent Hospital and Health Care Center, Indianapolis

46350

IU Health La Porte Hospital, La Porte

46360

Franciscan Saint Anthony Health-Michigan City, Michigan City

Woodland Cancer Care Center, Michigan City

46391

Michiana Hematology Oncology PC-Westville, Westville

46514

Michiana Hematology Oncology PC-Elkhart, Elkhart

46515

Elkhart General Hospital, Elkhart

46545

Cancer Care Partners LLC, Mishawaka

Memorial Regional Cancer Center Day Road, Mishawaka

Michiana Hematology Oncology PC-Mishawaka, Mishawaka

Saint Joseph Regional Medical Center-Mishawaka, Mishawaka

46563

Michiana Hematology Oncology PC-Plymouth, Plymouth

46601

Memorial Hospital of South Bend, South Bend

Michiana Hematology Oncology PC-South Bend, South Bend

46617

South Bend Clinic, South Bend

46628

Northern Indiana Cancer Research Consortium, South Bend

46904

Community Howard Regional Health, Kokomo

48162

Monroe Cancer Center, Monroe

49007

Bronson Methodist Hospital, Kalamazoo

West Michigan Cancer Center, Kalamazoo

49017

Bronson Battle Creek, Battle Creek

49048

Borgess Medical Center, Kalamazoo

49085

Lakeland Medical Center Saint Joseph, Saint Joseph

Marie Yeager Cancer Center, Saint Joseph

49120

Lakeland Hospital Niles, Niles

49444

Mercy Health Mercy Campus, Muskegon

49503

Cancer Research Consortium of West Michigan NCORP, Grand Rapids

Mercy Health Saint Mary's, Grand Rapids

Spectrum Health at Butterworth Campus, Grand Rapids

49519

Metro Health Hospital, Wyoming

49677

Spectrum Health Reed City Hospital, Reed City

49684

Munson Medical Center, Traverse City

51101

Siouxland Regional Cancer Center, Sioux City

51102

Mercy Medical Center-Sioux City, Sioux City

51104

Saint Luke's Regional Medical Center, Sioux City

53022

Aurora Health Care Germantown Health Center, Germantown

53024

Aurora Cancer Care-Grafton, Grafton

53066

Aurora Medical Center in Summit, Summit

53081

Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan

53105

Aurora Cancer Care-Southern Lakes VLCC, Burlington

53142

Aurora Cancer Care-Kenosha South, Kenosha

53188

Aurora Cancer Care-Waukesha, Waukesha

53209

Aurora Cancer Care-Milwaukee, Milwaukee

53215

Aurora Saint Luke's Medical Center, Milwaukee

53226

Aurora Cancer Care-Milwaukee West, Wauwatosa

53227

Aurora West Allis Medical Center, West Allis

53233

Aurora Sinai Medical Center, Milwaukee

53406

Aurora Cancer Care-Racine, Racine

54017

Cancer Center of Western Wisconsin, New Richmond

54143

Aurora Bay Area Medical Group-Marinette, Marinette

Bay Area Medical Center, Marinette

54241

Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers

54311

Aurora BayCare Medical Center, Green Bay

54904

Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh

54937

Aurora Health Center-Fond du Lac, Fond du Lac

55082

Lakeview Hospital, Stillwater

55101

Regions Hospital, Saint Paul

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

Saint John's Hospital - Healtheast, Maplewood

55125

Minnesota Oncology Hematology PA-Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55350

Hutchinson Area Health Care, Hutchinson

55379

Saint Francis Regional Medical Center, Shakopee

55387

Ridgeview Medical Center, Waconia

55407

Abbott-Northwestern Hospital, Minneapolis

55415

Hennepin County Medical Center, Minneapolis

55416

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55422

North Memorial Medical Health Center, Robbinsdale

55432

Unity Hospital, Fridley

55433

Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55454

Health Partners Inc, Minneapolis

56073

New Ulm Medical Center, New Ulm

56201

Rice Memorial Hospital, Willmar

59101

Billings Clinic Cancer Center, Billings

Saint Vincent Healthcare, Billings

59102

Montana Cancer Consortium NCORP, Billings

59405

Benefis Healthcare- Sletten Cancer Institute, Great Falls

Great Falls Clinic, Great Falls

59601

Saint Peter's Community Hospital, Helena

59701

Saint James Community Hospital and Cancer Treatment Center, Butte

59711

Community Hospital of Anaconda, Anaconda

59715

Bozeman Deaconess Hospital, Bozeman

59802

Montana Cancer Specialists, Missoula

Saint Patrick Hospital - Community Hospital, Missoula

59804

Community Medical Hospital, Missoula

59901

Kalispell Regional Medical Center, Kalispell

60026

NorthShore University HealthSystem-Glenbrook Hospital, Glenview

60035

NorthShore University HealthSystem-Highland Park Hospital, Highland Park

60076

North Shore Medical Center, Skokie

60201

NorthShore University HealthSystem-Evanston Hospital, Evanston

60451

UC Comprehensive Cancer Center at Silver Cross, New Lenox

60504

Rush - Copley Medical Center, Aurora

60521

Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale

60560

Rush-Copley Healthcare Center, Yorkville

60611

Northwestern University, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61801

Carle Cancer Center, Urbana

The Carle Foundation Hospital, Urbana

61832

Carle on Vermilion, Danville

61938

Carle Physician Group-Mattoon/Charleston, Mattoon

62401

Carle Physician Group-Effingham, Effingham

62864

Good Samaritan Regional Health Center, Mount Vernon

63109

Saint Louis Cancer and Breast Institute-South City, St Louis

63110

Barnes-Jewish Hospital, St Louis

Washington University School of Medicine, St Louis

63141

Mercy Hospital Saint Louis, St Louis

64804

Freeman Health System, Joplin

Mercy Hospital Joplin, Joplin

65401

Delbert Day Cancer Institute at PCRMC, Rolla

Mercy Clinic-Rolla-Cancer and Hematology, Rolla

65613

Central Care Cancer Center - Bolivar, Bolivar

65616

Cox Cancer Center Branson, Branson

65804

Cancer Research for the Ozarks NCORP, Springfield

Mercy Hospital Springfield, Springfield

65807

CoxHealth South Hospital, Springfield

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa

75235

Parkland Memorial Hospital, Dallas

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

78701

Dell Seton Medical Center at The University of Texas, Austin

82414

Big Horn Basin Cancer Center, Cody

Billings Clinic-Cody, Cody

82609

Rocky Mountain Oncology, Casper

82801

Welch Cancer Center, Sheridan

83301

Saint Luke's Cancer Institute - Twin Falls, Twin Falls

83619

Saint Luke's Cancer Institute - Fruitland, Fruitland

83642

Saint Luke's Cancer Institute - Meridian, Meridian

83686

Saint Luke's Cancer Institute - Nampa, Nampa

83712

Saint Luke's Cancer Institute - Boise, Boise

83814

Kootenai Health - Coeur d'Alene, Coeur d'Alene

83854

Kootenai Clinic Cancer Services - Post Falls, Post Falls

83864

Kootenai Cancer Clinic, Sandpoint

85004

Cancer Center at Saint Joseph's, Phoenix

85013

Saint Joseph's Hospital and Medical Center, Phoenix

87102

University of New Mexico Cancer Center, Albuquerque

87106

Southwest Gynecologic Oncology Associates Inc, Albuquerque

89106

Women's Cancer Center of Nevada, Las Vegas

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

91505

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank

92093

UC San Diego Moores Cancer Center, La Jolla

92354

Loma Linda University Medical Center, Loma Linda

97015

Clackamas Radiation Oncology Center, Clackamas

Providence Cancer Institute Clackamas Clinic, Clackamas

97045

Providence Willamette Falls Medical Center, Oregon City

97132

Providence Newberg Medical Center, Newberg

97213

Providence Portland Medical Center, Portland

97225

Providence Saint Vincent Medical Center, Portland

97420

Bay Area Hospital, Coos Bay

97701

Saint Charles Health System, Bend

98005

Swedish Cancer Institute-Eastside Oncology Hematology, Bellevue

98026

Swedish Cancer Institute-Edmonds, Edmonds

98029

Swedish Cancer Institute-Issaquah, Issaquah

98104

Minor and James Medical PLLC, Seattle

Pacific Gynecology Specialists, Seattle

98107

Swedish Medical Center-Ballard Campus, Seattle

98112

Kaiser Permanente Washington, Seattle

98201

Providence Regional Cancer Partnership, Everett

98221

Cancer Care Center at Island Hospital, Anacortes

98225

PeaceHealth Saint Joseph Medical Center, Bellingham

98503

Providence Regional Cancer System-Lacey, Lacey

98508

Anchorage Associates in Radiation Medicine, Anchorage

98520

Providence Regional Cancer System-Aberdeen, Aberdeen

98531

Providence Regional Cancer System-Centralia, Centralia

98584

Providence Regional Cancer System-Shelton, Shelton

98597

Providence Regional Cancer System-Yelm, Yelm

98632

PeaceHealth Saint John Medical Center, Longview

98664

PeaceHealth Southwest Medical Center, Vancouver

98902

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima

99204

MultiCare Deaconess Cancer and Blood Specialty Center - Downtown, Spokane

99216

MultiCare Deaconess Cancer and Blood Specialty Center - Valley, Spokane Valley

99218

MultiCare Deaconess Cancer and Blood Specialty Center - North, Spokane

99362

Providence Saint Mary Regional Cancer Center, Walla Walla

99504

Anchorage Radiation Therapy Center, Anchorage

99508

Alaska Breast Care and Surgery LLC, Anchorage

Alaska Oncology and Hematology LLC, Anchorage

Alaska Regional Hospital, Anchorage

Alaska Women's Cancer Care, Anchorage

Anchorage Oncology Centre, Anchorage

Katmai Oncology Group, Anchorage

Providence Alaska Medical Center, Anchorage

06102

Hartford Hospital, Hartford

06050

The Hospital of Central Connecticut, New Britain

46514-2098

Elkhart Clinic, Elkhart

04102

Maine Medical Center-Bramhall Campus, Portland

04074

Maine Medical Center- Scarborough Campus, Scarborough

20889-5600

Walter Reed National Military Medical Center, Bethesda

02115

Brigham and Women's Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

02905

Women and Infants Hospital, Providence

98122-4307

Swedish Medical Center-First Hill, Seattle

M4N 3M5

Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

980-8574

Tohoku University School of Medicine, Sendai

060-8648

Hokkaido University Hospital, Sapporo

028-3695

Iwate Medical University Hospital, Shiwa-gun

890-8760

Kagoshima City Hospital, Kagoshima

951-8520

Niigata University Medical and Dental Hospital, Niigata

903-0215

University of the Ryukyus Hospital-Col Health Scnc, Nakagami-gun

734-8551

Hiroshima University Hospital, Hiroshima

589 8511

Kindai University, Osaka

350-1298

Saitama Medical University International Medical Center, Saitama

680-8550

Tottori University, Tottori

135-710

Samsung Medical Center, Seoul

137-040

Catholic University of Korea-Seoul Saint Mary's Hospital, Seoul

463-707

Seoul National University Bundang Hospital, Seongnam

405-760

Gachon University Gil Hospital, Incheon

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Seoul

110-744

Seoul National University Hospital, Seoul

139-706

Korea Cancer Center Hospital, Seoul

S10 2SJ

Weston Park Hospital, Sheffield

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

GOG Foundation

NETWORK

NCT01535053 - Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia | Biotech Hunter | Biotech Hunter