Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00063999
Other study ID # GOG-0209
Secondary ID NCI-2009-00584CD
Status Completed
Phase Phase 3
First received
Last updated
Start date August 25, 2003
Est. completion date January 5, 2021

Study information

Verified date September 2021
Source GOG Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial compares how well two different combination chemotherapy regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride, cisplatin, paclitaxel, and carboplatin, 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 which combination chemotherapy regimen is more effective in treating endometrial cancer.


Description:

PRIMARY OBJECTIVES: I. To determine if the combination of carboplatin and paclitaxel (TC) chemotherapy is therapeutically equivalent to the combination of doxorubicin (doxorubicin hydrochloride), cisplatin and paclitaxel (TAP) chemotherapy with regards to survival. II. To determine if estrogen/progesterone receptor status provides prognostic information in patients treated with chemotherapy. III. To assess whether combination TC chemotherapy is superior to combination TAP chemotherapy with regards to toxicity profile, specifically neurotoxicity and infection. IV. To measure differences in patient-reported neurotoxicity and quality of life (QOL) among the regimens. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with left ventricular ejection fraction < 50% at randomization who are initially randomized to Arm I are immediately crossed over to Arm II. ARM I: Patients receive doxorubicin hydrochloride intravenously (IV) over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim subcutaneously (SC) on days 3-12 or pegfilgrastim SC on day 3. ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.


Recruitment information / eligibility

Status Completed
Enrollment 1381
Est. completion date January 5, 2021
Est. primary completion date June 29, 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must have primary stage III or stage IV or recurrent endometrial carcinoma whose potential for cure by radiation therapy or surgery alone or in combination is very poor; pathological confirmation and estrogen receptor (ER)/progesterone receptor (PR) status of the primary tumor is mandatory; however, the results do not need to be available prior to registration - Patients may not have received prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization; patients may have received prior radiation therapy, hormonal therapy, or therapy with biologic agents, but such therapies must be discontinued prior to entry on this study - Patients in whom both radiation and chemotherapy is planned must receive radiation prior to entry on this study; at least four weeks should have elapsed since completion of radiation therapy (RT) involving the whole pelvis or over 50% of the spine - Platelets >= 100,000/mcl - Granulocytes (absolute neutrophil count [ANC]) >= 1,500/mcl - Creatinine =< upper limit of normal (ULN) (Common Toxicity Criteria [CTC] grade 0) or calculated creatinine clearance (Jeliffe Formula) >= 60 ml/min - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limits of normal - Bilirubin =< institutional upper limits of normal - Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 - Patients must have met the pre-entry requirements - Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: - Patients with a concomitant malignancy other than non-melanoma skin cancer; with the exception of non-melanoma skin cancer, patients with a prior invasive malignancy who have been disease-free for < 5 years or who received prior chemotherapy for that malignancy - Patients in whom pathological confirmation and estrogen receptor (ER)/progesterone receptor (PR) status of the tumor is not obtainable - Patients for whom radiation therapy is planned during or after study chemotherapy prior to demonstrated progression - Patients with concomitant medical illness such as serious uncontrolled infection, uncontrolled angina, or serious peripheral neuropathy, which, in the opinion of the treating physician, make the treatments prescribed on this study unreasonably hazardous for the patient - Patients with third degree or complete heart block are not eligible unless a pacemaker is in place; patients on medications which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction may be placed on study at the discretion of the investigator - Patients with history of myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious for congestive heart failure are not eligible unless a left ventricular ejection fraction in the past 6 months is documented to be 50% or greater; patients who have had a left ventricular ejection fraction (LVEF) (performed for any reason) of less than 50% in the past 6 months are ineligible - Patients whose circumstances will not permit study completion or adequate follow-up - Patients who are sensitive to E. coli-derived drug preparations - Patients with uterine carcinosarcoma or other non-epithelial uterine malignancies

Study Design


Related Conditions & MeSH terms

  • Endometrial Neoplasms
  • Recurrent Uterine Corpus Carcinoma
  • Stage IIIA Uterine Corpus Cancer AJCC v7
  • Stage IIIB Uterine Corpus Cancer AJCC v7
  • Stage IIIC Uterine Corpus Cancer AJCC v7
  • Stage IVA Uterine Corpus Cancer AJCC v7
  • Stage IVB Uterine Corpus Cancer AJCC v7

Intervention

Drug:
Carboplatin
Given IV
Cisplatin
Given IV
Doxorubicin Hydrochloride
Given IV
Biological:
Filgrastim
Given SC
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Paclitaxel
Given IV
Biological:
Pegfilgrastim
Given SC
Other:
Quality-of-Life Assessment
Ancillary studies

Locations

Country Name City State
Canada McGill University Health Centre at Royal Victoria Hospital Montreal Quebec
Canada Montreal General Hospital Montreal Quebec
Canada Saint Mary's Hospital Montreal Quebec
Canada CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec City Quebec
Japan Hiroshima University Hospital Hiroshima City
Japan Kagoshima City Hospital Kagoshima City Kagoshima
Japan Jikei University Aoto Hospital Katsushika-ku Tokyo
Japan National Hospital Organization-Kobe Medical Center Kobe
Japan Kure National Hospital Kure Hiroshima
Japan Shikoku Cancer Center Matsuyama
Japan National Kyushu Cancer Center Minami-ku
Japan Jikei University School of Medicine Minato-ku, Tokyo
Japan Saitama Medical University International Medical Center Saitama
Japan Hokkaido University Hospital Sapporo Hokkaido
Japan Tohoku University School of Medicine Sendai Aoba-ku
Japan Keio University Shinjuku-ku Tokyo
Japan Iwate Medical University Hospital Shiwa-gun Iwate
Japan National Cancer Center Hospital Tokyo
Japan Tottori University Tottori
United States Pali Momi Medical Center 'Aiea Hawaii
United States Jefferson Abington Hospital Abington Pennsylvania
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Cleveland Clinic Akron General Akron Ohio
United States Summa Health System - Akron Campus Akron Ohio
United States New York Oncology Hematology PC - Albany Medical Center Albany New York
United States Women's Cancer Care Associates LLC Albany New York
United States Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States McFarland Clinic PC - Ames Ames Iowa
United States New York Oncology Hematology PC - Amsterdam Amsterdam New York
United States Providence Alaska Medical Center Anchorage Alaska
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Northern Virginia Pelvic Surgery Associates Annandale Virginia
United States Northwest Community Hospital Arlington Heights Illinois
United States Randolph Hospital Asheboro North Carolina
United States Hope Women's Cancer Centers-Asheville Asheville North Carolina
United States Atlanta Regional CCOP Atlanta Georgia
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Southeastern Gynecologic Oncology LLP Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States Colorado Gynecologic Oncology Group Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States WellStar Cobb Hospital Austell Georgia
United States Greater Baltimore Medical Center Baltimore Maryland
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Baton Rouge General Medical Center Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Woman's Hospital Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States University of Iowa Healthcare Cancer Services Quad Cities Bettendorf Iowa
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Deaconess Medical Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Saint Joseph Medical Center Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Hospital Bozeman Montana
United States Internal Medicine of Bozeman Bozeman Montana
United States Island Gynecologic Oncology Brightwaters New York
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Wakefield Campus Bronx New York
United States State University of New York Downstate Medical Center Brooklyn New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States University of Vermont Medical Center Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Cooper Hospital University Medical Center Camden New Jersey
United States Aultman Health Foundation Canton Ohio
United States Cleveland Clinic Mercy Hospital Canton Ohio
United States Graham Hospital Association Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Missouri Hospital Cape Girardeau Missouri
United States Marion Community Hospital Carbondale Pennsylvania
United States Memorial Hospital Carthage Illinois
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Saint Luke's Hospital Cedar Rapids Iowa
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States University of Virginia Cancer Center Charlottesville Virginia
United States Chattanooga's Program in Women's Oncology Chattanooga Tennessee
United States Mount Sinai Hospital Medical Center Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Swedish Covenant Hospital Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Morton Plant Hospital Clearwater Florida
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States New York Oncology Hematology PC - Clifton Park Clifton Park New York
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States North Coast Cancer Care-Clyde Clyde Ohio
United States Prisma Health Richland Hospital Columbia South Carolina
United States South Carolina Oncology Associates PA Columbia South Carolina
United States University of Missouri - Ellis Fischel Columbia Missouri
United States University of South Carolina School of Medicine Columbia South Carolina
United States John B Amos Cancer Center Columbus Georgia
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States John Muir Medical Center-Concord Campus Concord California
United States Mercy Hospital Coon Rapids Minnesota
United States Clements University Hospital Dallas Texas
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Danville Regional Medical Center Danville Virginia
United States Mercy Fitzgerald Hospital Darby Pennsylvania
United States Genesis Cancer Care Institute Davenport Iowa
United States Genesis Medical Center - East Campus Davenport Iowa
United States Dayton NCI Community Oncology Research Program Dayton Ohio
United States Dayton Veterans Affairs Medical Center Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Decatur Memorial Hospital Decatur Illinois
United States Dekalb Medical Center Decatur Georgia
United States Heartland Cancer Research NCORP Decatur Illinois
United States University of Colorado Denver Colorado
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Capitol Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States City of Hope Comprehensive Cancer Center Duarte California
United States Oncology Hematology Associates of Northern Pennsylvania DuBois Pennsylvania
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Duke University Medical Center Durham North Carolina
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States University of Maryland Shore Medical Center at Easton Easton Maryland
United States HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Moorehead Memorial Hospital Eden North Carolina
United States Saint Elizabeth Medical Center South Edgewood Kentucky
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart General Hospital Elkhart Indiana
United States Christiana Care - Union Hospital Elkton Maryland
United States Hematology Oncology Center Incorporated Elyria Ohio
United States Rocky Mountain Gynecologic Oncology PC Englewood Colorado
United States Ephrata Cancer Center Ephrata Pennsylvania
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Saint Francis Hospital Evanston Illinois
United States Kaiser Permanente - Fair Oaks Medical Center Fairfax Virginia
United States Sanford Broadway Medical Center Fargo North Dakota
United States Southside Community Hospital Farmville Virginia
United States Highlands Oncology Group PA - Fayetteville Fayetteville Arkansas
United States Washington Regional Medical Center - Fayetteville Fayetteville Arkansas
United States Blanchard Valley Hospital Findlay Ohio
United States Hunterdon Medical Center Flemington New Jersey
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Saint Agnes Hospital/Agnesian Cancer Center Fond Du Lac Wisconsin
United States Poudre Valley Hospital Fort Collins Colorado
United States Broward Health Medical Center Fort Lauderdale Florida
United States Florida Gynecologic Oncology Fort Myers Florida
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Fort Wayne Medical Oncology and Hematology Inc-Parkview Fort Wayne Indiana
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Fremont Memorial Hospital Fremont Ohio
United States Kaiser Permanente-Fremont Fremont California
United States Unity Hospital Fridley Minnesota
United States Saint Jude Medical Center Fullerton California
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States Galesburg Cottage Hospital Galesburg Illinois
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States University of Texas Medical Branch Galveston Texas
United States Peninsula Cancer Institute-Gloucester Gloucester Virginia
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Wayne Radiation Oncology Goldsboro North Carolina
United States Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Spectrum Health-Blodgett Campus Grand Rapids Michigan
United States Three Rivers Community Hospital Grants Pass Oregon
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Marin Cancer Care Inc Greenbrae California
United States Cone Health Cancer Center Greensboro North Carolina
United States Gynecologic Oncology Network Greenville North Carolina
United States Vidant Medical Center Greenville North Carolina
United States Virginia Oncology Associates-Hampton Hampton Virginia
United States Hartford Hospital Hartford Connecticut
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Ingalls Memorial Hospital Harvey Illinois
United States Mason District Hospital Havana Illinois
United States Northern Montana Hospital Havre Montana
United States Saint Peter's Community Hospital Helena Montana
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois
United States Holland Community Hospital Holland Michigan
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Hopedale Medical Complex - Hospital Hopedale Illinois
United States Houston Methodist Hospital Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States New York Oncology Hematology PC-Hudson Hudson New York
United States Clearview Cancer Institute Huntsville Alabama
United States Cancer Center of Kansas-Independence Independence Kansas
United States Centerpoint Medical Center LLC Independence Missouri
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Saint Vincent Hospital and Health Care Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States Saint Dominic-Jackson Memorial Hospital Jackson Mississippi
United States University of Mississippi Medical Center Jackson Mississippi
United States Mayo Clinic in Florida Jacksonville Florida
United States Saint Vincent's Medical Center Jacksonville Florida
United States East Tennessee State University Johnson City Tennessee
United States Duly Health and Care Joliet Joliet Illinois
United States Freeman Health System Joplin Missouri
United States Jupiter Medical Center Jupiter Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States Kalamazoo Center for Medical Studies Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Presence Saint Mary's Hospital Kankakee Illinois
United States North Kansas City Hospital Kansas City Missouri
United States Providence Medical Center Kansas City Kansas
United States Radiation Oncology Practice Corporation - North Kansas City Missouri
United States Radiation Oncology Practice Corporation South Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Joseph Health Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Truman Medical Centers Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States CHI Health Good Samaritan Kearney Nebraska
United States Keesler Medical Center Keesler Air Force Base Mississippi
United States Kettering Medical Center Kettering Ohio
United States Kewanee Hospital Kewanee Illinois
United States Rappahannock General Hospital Kilmarnock Virginia
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Vidant Oncology-Kinston Kinston North Carolina
United States East Tennessee Baptist Hospital-Mercy Health Partners Knoxville Tennessee
United States Knoxville Gynecologic Cancer Specialists PC Knoxville Tennessee
United States Southeast Gynecologic Oncology Associates Knoxville Tennessee
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States IU Health La Porte Hospital La Porte Indiana
United States Northwell Health NCORP Lake Success New York
United States Sparrow Hospital Lansing Michigan
United States Kaiser Permanente - Largo Medical Center Largo Maryland
United States Nevada Cancer Research Foundation NCORP Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Northside Hospital - Gwinnett Lawrenceville Georgia
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Beebe Medical Center Lewes Delaware
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Southwest Medical Center Liberal Kansas
United States Liberty Radiation Oncology Center Liberty Missouri
United States Lima Memorial Hospital Lima Ohio
United States Saint Rita's Medical Center Lima Ohio
United States Bryan LGH Medical Center East Lincoln Nebraska
United States Bryan LGH Medical Center West Lincoln Nebraska
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Barnabas Medical Center Livingston New Jersey
United States Saint Mary Mercy Hospital Livonia Michigan
United States Logan Regional Hospital Logan Utah
United States Long Beach Memorial Medical Center-Todd Cancer Institute Long Beach California
United States Cedars Sinai Medical Center Los Angeles California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Community Hospital of Los Gatos Los Gatos California
United States Norton Hospital Pavilion and Medical Campus Louisville Kentucky
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States Texas Tech University Health Sciences Center-Lubbock Lubbock Texas
United States Kaiser Permanente - Towson Medical Center Lutherville Maryland
United States Mcdonough District Hospital Macomb Illinois
United States Central Georgia Gynecologic Oncology Macon Georgia
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States North Shore University Hospital Manhasset New York
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Wellstar Kennestone Hospital Marietta Georgia
United States Bay Area Medical Center Marinette Wisconsin
United States Marshfield Medical Center Marshfield Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Saint Luke's Hospital Maumee Ohio
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Loyola University Medical Center Maywood Illinois
United States Asante Health System Medford Oregon
United States Providence Medford Medical Center Medford Oregon
United States Rogue Valley Medical Center Medford Oregon
United States Riddle Memorial Hospital Media Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States University of Tennessee Health Science Center Memphis Tennessee
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin
United States Mercy Hospital Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Eastern Montana Cancer Center Miles City Montana
United States Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Mobile Infirmary Medical Center Mobile Alabama
United States Providence Hospital Mobile Alabama
United States Doctors Medical Center Modesto California
United States Memorial Medical Center Modesto California
United States Mercy Memorial Hospital Monroe Michigan
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Mountainside Hospital Montclair New Jersey
United States Morristown Medical Center Morristown New Jersey
United States Virtua Memorial Mount Holly New Jersey
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Inspira Medical Center Mullica Hill Mullica Hill New Jersey
United States Cottonwood Hospital Medical Center Murray Utah
United States Intermountain Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States Mercy Health Partners-Hackley Campus Muskegon Michigan
United States Meharry Medical College Nashville Tennessee
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Jersey Shore Medical Center Neptune New Jersey
United States The Hospital of Central Connecticut New Britain Connecticut
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States Long Island Jewish Medical Center New Hyde Park New York
United States Louisiana State University Health Science Center New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai Hospital New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Rutgers New Jersey Medical School Newark New Jersey
United States Bon Secours Mary Immaculate Hospital Newport News Virginia
United States Peninsula Cancer Institute-Newport News Newport News Virginia
United States Cancer Center of Kansas - Newton Newton Kansas
United States Virginia Oncology Associates - Lake Wright Norfolk Virginia
United States Bromenn Regional Medical Center Normal Illinois
United States Carle Cancer Institute Normal Normal Illinois
United States Kaiser Permanente-Oakland Oakland California
United States South Nassau Communities Oceanside New York
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Franciscan St. James Health-Olympia Fields Campus Olympia Fields Illinois
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States AdventHealth Orlando Orlando Florida
United States Orlando Health Cancer Institute Orlando Florida
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Radiation Oncology Practice Corporation Southwest Overland Park Kansas
United States Chicago Gynecologic Oncology SC Palatine Illinois
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Singing River Hospital Pascagoula Mississippi
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Pekin Hospital Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Hospital Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States McLaren Cancer Institute-Northern Michigan Petoskey Michigan
United States Drexel University School of Medicine Philadelphia Pennsylvania
United States Einstein Medical Center Philadelphia Philadelphia Pennsylvania
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Jefferson Torresdale Hospital Philadelphia Pennsylvania
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States AtlantiCare Regional Medical Center -Main Campus Pomona New Jersey
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Compass Oncology Rose Quarter Portland Oregon
United States Kaiser Permanente Northwest Portland Oregon
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
United States Maine Medical Center-Bramhall Campus Portland Maine
United States Oregon Health and Science University Portland Oregon
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Perry Memorial Hospital Princeton Illinois
United States Women and Infants Hospital Providence Rhode Island
United States Utah Valley Regional Medical Center Provo Utah
United States Dana Farber Community Cancer Care-Quincy Quincy Massachusetts
United States Ascension All Saints Hospital Racine Wisconsin
United States Black Hills Obstetrics and Gynecology Rapid City South Dakota
United States Riverview Medical Center/Booker Cancer Center Red Bank New Jersey
United States Kaiser Permanente-Redwood City Redwood City California
United States Annie Penn Memorial Hospital Reidsville North Carolina
United States Center of Hope at Renown Medical Center Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Women's Cancer Center at Washoe Reno Nevada
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States Richmond Radiation Oncology Center Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Southern Regional Medical Center Riverdale Georgia
United States Carilion Clinic Gynecological Oncology Roanoke Virginia
United States Oncology and Hematology Associates of Southwest Virginia Roanoke Virginia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota
United States OSF Saint Anthony Medical Center Rockford Illinois
United States Swedish American Hospital Rockford Illinois
United States Kaiser Permanente - Shady Grove Medical Center Rockville Maryland
United States Harbin Clinic Medical Oncology and Clinical Research Rome Georgia
United States Kaiser Permanente-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Sarah Culbertson Memorial Hospital Rushville Illinois
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Dixie Medical Center Regional Cancer Center Saint George Utah
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Center for Cancer Care and Research Saint Louis Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Saint Louis-Cape Girardeau CCOP Saint Louis Missouri
United States Saint Mary's Hospital Saint Louis Missouri
United States SSM Health Saint Louis University Hospital Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States United Hospital Saint Paul Minnesota
United States Bayfront Outpatient Health Clinic Saint Petersburg Florida
United States UH Seidman Cancer Center at Salem Regional Medical Center Salem Ohio
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salinas Valley Memorial Salinas California
United States TidalHealth Peninsula Regional Salisbury Maryland
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Intermountain Health Care Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Alvarado Hospital Medical Center San Diego California
United States University of California San Diego San Diego California
United States Kaiser Permanente-San Francisco San Francisco California
United States UCSF Medical Center-Mount Zion San Francisco California
United States Zuckerberg San Francisco General Hospital San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Rafael San Rafael California
United States Firelands Regional Medical Center Sandusky Ohio
United States North Coast Cancer Care Sandusky Ohio
United States Cancer Center of Santa Barbara Santa Barbara California
United States Ridley-Tree Cancer Center Santa Barbara California
United States Sansum Clinic Inc Santa Barbara California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Sarasota Memorial Hospital Sarasota Florida
United States Memorial Health University Medical Center Savannah Georgia
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Hematology and Oncology Associates of North East Pennsylvania Scranton Pennsylvania
United States Mercy Hospital Scranton Pennsylvania
United States Moses Taylor Hospital Scranton Pennsylvania
United States Scranton Hematology Oncology Scranton Pennsylvania
United States TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Advent Health - Shawnee Mission Medical Center Shawnee Mission Kansas
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Welch Cancer Center Sheridan Wyoming
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Vince Lombardi Cancer Clinic - Slinger Slinger Wisconsin
United States Ridley-Tree Cancer Center-Solvang Solvang California
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States VCU Community Memorial Health Center South Hill Virginia
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Sparta Cancer Treatment Center Sparta New Jersey
United States Saint Margaret's Hospital Spring Valley Illinois
United States Baystate Medical Center Springfield Massachusetts
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Kaiser Permanente-Stockton Stockton California
United States Stony Brook University Medical Center Stony Brook New York
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Overlook Hospital Summit New Jersey
United States Olive View-University of California Los Angeles Medical Center Sylmar California
United States ProMedica Flower Hospital Sylvania Ohio
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Moffitt Cancer Center Tampa Florida
United States Scott and White Memorial Hospital Temple Texas
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Upper Valley Medical Center Troy Ohio
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Associates In Hematology Oncology PC-Upland Upland Pennsylvania
United States Carle Cancer Center Urbana Illinois
United States Kaiser Permanente-Vallejo Vallejo California
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Inspira Medical Center Vineland Vineland New Jersey
United States Virtua Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States Pacific Cancer Institute of Maui Wailuku Hawaii
United States John Muir Medical Center-Walnut Creek Walnut Creek California
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States MedStar Washington Hospital Center Washington District of Columbia
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Good Samaritan Hospital Medical Center West Islip New York
United States Florida Cancer Specialists-West Palm Beach West Palm Beach Florida
United States Reading Hospital West Reading Pennsylvania
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Peninsula Cancer Institute-Williamsburg Williamsburg Virginia
United States Clinton Memorial Hospital Wilmington Ohio
United States Saint Francis Hospital - Wilmington Wilmington Delaware
United States Wilson Medical Center Wilson North Carolina
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Novant Health Oncology Specialists Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Cancer Treatment Center Wooster Ohio
United States UMass Memorial Medical Center - University Campus Worcester Massachusetts
United States Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Main Line Health NCORP Wynnewood Pennsylvania
United States Metro Health Hospital Wyoming Michigan
United States Greene Memorial Hospital Xenia Ohio
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio

Sponsors (2)

Lead Sponsor Collaborator
GOG Foundation National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Alive at Time of Last Follow-up. The time alive in months from study entry to last contact or death. Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.
Secondary Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life). Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start
Secondary Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL. Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment
Secondary Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative) The time alive in months from study entry to last contact or death. Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years.
Secondary Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection Maximum grade of physician assessed neurotoxicity and infection Assessed throughout the treatment period and for 30 days after discontinuation of treatment.
See also
  Status Clinical Trial Phase
Completed NCT01010126 - Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer Phase 2
Completed NCT01642082 - Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT01208467 - Prognostic Biomarkers in Patients With Endometrial Cancer N/A
Completed NCT01011933 - Selumetinib in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT00729586 - Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer Phase 2
Completed NCT01440998 - Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer Phase 1
Completed NCT00006089 - Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Phase 2
Completed NCT01225887 - Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT00410553 - Eribulin Mesylate and Gemcitabine Hydrochloride in Treating Patients With Metastatic Solid Tumors or Solid Tumors That Cannot be Removed by Surgery Phase 1
Active, not recruiting NCT02208375 - mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Phase 1/Phase 2
Active, not recruiting NCT01970722 - Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer Phase 1
Completed NCT02996825 - Mirvetuximab Soravtansine and Gemcitabine Hydrochloride in Treating Patients With FRalpha-Positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial, or Triple Negative Breast Cancer Phase 1
Completed NCT01522820 - Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors Phase 1
Completed NCT01307631 - Akt Inhibitor MK2206 in Treating Patients With Recurrent or Advanced Endometrial Cancer Phase 2
Active, not recruiting NCT02065687 - Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer Phase 2/Phase 3
Completed NCT01210222 - Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer Phase 2
Completed NCT01132820 - Cediranib Maleate in Treating Patients With Recurrent or Persistent Endometrial Cancer Phase 2
Completed NCT00027690 - Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer Phase 2
Completed NCT00897442 - Collecting Tumor Samples From Patients With Gynecological Tumors N/A
Completed NCT02657928 - Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer Phase 2