We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    GOG 0275
Previous Study | Return to List | Next Study

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535053
First Posted: February 17, 2012
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  Purpose
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, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

Condition Intervention Phase
Choriocarcinoma FIGO Stage I Gestational Trophoblastic Tumor FIGO Stage II Gestational Trophoblastic Tumor FIGO Stage III Gestational Trophoblastic Tumor Hydatidiform Mole Biological: Dactinomycin Drug: Leucovorin Calcium Drug: Methotrexate Other: Quality-of-Life Assessment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Complete response vs treatment failure [ Time Frame: Up to 2 years ]
    The information fraction is estimated by the number of eligible patients evaluated for response at a given time divided by the target sample size of eligible patients. However, the timing of the interim analyses will likely vary from this exact schedule for practical reasons. At the interim analysis, the test statistic for the primary analysis will be compared with the critical boundaries defined by the statistical design parameters an O'Brien and Fleming alpha spending function as proposed by Lan and DeMets.


Secondary Outcome Measures:
  • Overall QOL as measured by Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: Up to 26 weeks ]
    A linear mixed model that accounts for the correlation among the repeated measures will be fitted for the FACT-G score adjusting for baseline score and other covariates. The patient-reported symptom measurement scores and treatment disruption on QOL will be summarized by treatment arms with the estimated means for continuous variables or frequency tables for categorical variables accompanied with 95% confidence intervals.

  • Severity of adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 2 years ]
    The maximum grade of any adverse event observed during active treatment period or within 4 weeks of completing study treatment for each eligible patient will be tabulated. The proportion of patients with a serious adverse event or reported grade 3 or worse adverse event, regardless of attribution, will be compared between the treatment regimens using a chi-square test.

  • UAPI (optional) [ Time Frame: Up to 2 years ]
    Analyses will report predictiveness curves (with observed risk for assessing calibration) for UAPI with and without the interaction term, functions of sensitivity, specificity and risk, risk distribution by treatment outcome, and area under curve from receiver operating characteristic analysis. These analyses will help to evaluate the predictive accuracy of UAPI when predicting resistance to standard single agent therapy.


Estimated Enrollment: 384
Actual Study Start Date: June 18, 2012
Estimated Primary Completion Date: May 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (dactinomcin)
Patients receive dactinomycin IV over 15 minutes on day 1.
Biological: Dactinomycin
Given IV
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Active Comparator: Arm II (leucovorin calcium and methotrexate)
Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.
Drug: Leucovorin Calcium
Given PO
Drug: Methotrexate
Given IV and IM
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Detailed Description:

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 dactinomycin intravenously (IV) over 15 minutes on day 1.

ARM II: 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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 3 weeks (> 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535053


  Hide Study Locations
Locations
United States, Alaska
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States, 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States, 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
Alaska Regional Hospital
Anchorage, Alaska, United States, 99508
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Anchorage Oncology Centre
Anchorage, Alaska, United States, 99508
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
University of Arizona Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Northside Hospital-Forsyth
Cumming, Georgia, United States, 30041
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States, 30501
Memorial University Medical Center
Savannah, Georgia, United States, 31404
Summit Cancer Care-Memorial
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
Low Country Cancer Care Associates PC
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States, 83619
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States, 83686
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Carle on Vermilion
Danville, Illinois, United States, 61832
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States, 60026
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States, 60035
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
North Shore Medical Center
Skokie, Illinois, United States, 60076
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Rush-Copley Healthcare Center
Yorkville, Illinois, United States, 60560
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Woodland Cancer Care Center
Michigan City, Indiana, United States, 46360
Cancer Care Partners LLC
Mishawaka, Indiana, United States, 46545
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States, 46391
United States, Iowa
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kentucky
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States, 41017
United States, Maine
Maine Medical Center-Bramhall Campus
Portland, Maine, United States, 04102
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Monroe Cancer Center
Monroe, Michigan, United States, 48162
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Lakeland Community Hospital
Niles, Michigan, United States, 49120
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Lakeland Hospital
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States, 65613
CoxHealth Cancer Center
Branson, Missouri, United States, 65616
Freeman Health System
Joplin, Missouri, United States, 64804
Mercy Hospital-Joplin
Joplin, Missouri, United States, 64804
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States, 65401
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Montana
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Montana Cancer Consortium NCORP
Billings, Montana, United States, 59102
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59804
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States, 87106
United States, New York
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Delaware Radiation Oncology
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lancaster Radiation Oncology
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Newark Radiation Oncology
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Flower Hospital
Sylvania, Ohio, United States, 43560
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Saint Charles Health System
Bend, Oregon, United States, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, United States, 97015
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States, 15009
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States, 15901
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon, Pennsylvania, United States, 15108
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
UPMC Jefferson Regional Radiation Oncology
Pittsburgh, Pennsylvania, United States, 15236
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania, United States, 15401
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, United States, 15301
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
United States, Texas
Dell Seton Medical Center at The University of Texas
Austin, Texas, United States, 78701
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
United States, Washington
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States, 98520
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue, Washington, United States, 98005
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Providence Regional Cancer System-Centralia
Centralia, Washington, United States, 98531
Swedish Medical Center-Edmonds
Edmonds, Washington, United States, 98026
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Providence Regional Cancer System-Lacey
Lacey, Washington, United States, 98503
PeaceHealth Saint John Medical Center
Longview, Washington, United States, 98632
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States, 98107
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Providence Regional Cancer System-Shelton
Shelton, Washington, United States, 98584
Rockwood Clinic Cancer Treatment Center-Valley
Spokane Valley, Washington, United States, 99216
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States, 99204
Rockwood North Cancer Treatment Center
Spokane, Washington, United States, 99218
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Providence Regional Cancer System-Yelm
Yelm, Washington, United States, 98597
United States, West Virginia
Monongalia Hospital
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States, 53105
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, United States, 54937
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States, 53142
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States, 54143
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora Cancer Care-Racine
Racine, Wisconsin, United States, 53406
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States, 54241
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States, 53188
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Big Horn Basin Cancer Center
Cody, Wyoming, United States, 82414
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Canada, Ontario
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Japan
Tohoku University School of Medicine
Sendai, Aoba-ku, Japan, 980-8574
Kure National Hospital
Kure, Hiroshima, Japan, 737
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Iwate Medical University School of Medicine
Morioka, Iwate, Japan, 020-8505
Kagoshima City Hospital
Kagoshima City, Kagoshima, Japan, 890-8760
Niigata University Medical and Dental Hospital
Niigata City, Niigata, Japan, 951-8520
University of the Ryukyus Hospital-Col Health Scnc
Nakagami-gun, Okinawa, Japan, 903-0215
Hiroshima University Hospital
Hiroshima City, Japan, 734-8551
Kindai University
Osaka, Osaka, Japan, 589 8511
Saitama Medical University International Medical Center
Saitama, Japan, 350-1298
Tottori University
Tottori, Japan, 680-8550
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Korea, Republic of, 135-710
Catholic University of Korea-Seoul Saint Mary's Hospital
Seoul, Korea, Korea, Republic of, 137-040
Seoul National University Bundang Hospital
Seongnam City, Kyeonggi-do, Korea, Republic of, 463-707
Gachon University Gil Hospital
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea Cancer Center Hospital
Seoul, Korea, Republic of, 139-706
United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom, S10 2SJ
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Julian Schink NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01535053     History of Changes
Other Study ID Numbers: GOG-0275
NCI-2012-00250 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000725211
PGOG-0275_A08PAMDREVW01
GOG-0275 ( Other Identifier: NRG Oncology )
GOG-0275 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: February 14, 2012
First Posted: February 17, 2012
Last Update Posted: August 24, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Choriocarcinoma
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Hydatidiform Mole
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Calcium, Dietary
Methotrexate
Dactinomycin
Levoleucovorin
Leucovorin
Bone Density Conservation Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents