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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00807768
Other study ID # GOG-0249
Secondary ID NCI-2009-00610CD
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 23, 2009

Study information

Verified date March 2019
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as 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 whether pelvic radiation therapy alone is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.


Description:

PRIMARY OBJECTIVES:

I. To determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e. increases recurrence-free survival) when compared to pelvic radiation therapy.

SECONDARY OBJECTIVES:

I. To compare survival between the two treatment groups. II. To compare patterns of failure between the two treatment groups. III. To compare physical functioning, fatigue and neurotoxicity between the two treatment groups.

IV. To examine associations between primary comorbid illnesses and obesity on survival, fatigue and physical functioning.

V. To evaluate the psychometric properties (such as construct validity, reliability, sensitivity to treatment and responsiveness over time) of the Patient-Reported-Outcomes Measurement Information System (PROMIS) Fatigue Short form 1, and to evaluate fatigue measurement equivalence between women with endometrial cancer and age-matched women from the general United States (US) population.

TERTIARY OBJECTIVES:

I. To evaluate the ability of gene expression signatures in early stage endometrial cancer to predict recurrence and to explore the association between gene expression signatures in early stage endometrial cancer and clinical characteristics and outcome.

II. To bank whole blood specimens for future research.

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

ARM I: Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.

ARM II: Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 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 for up to 5 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 601
Est. completion date
Est. primary completion date December 29, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- To be considered eligible to participate in this trial, all patients must have undergone hysterectomy; bilateral salpingo-oophorectomy (open or laparoscopic approach) is strongly encouraged

- Peritoneal cytology should be obtained on entering the peritoneal cavity, as described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual (https://gogmember.gog.org/manuals/pdf/surgman.pdf); pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged (as staged patients enrolled on GOG-0210-molecular markers in endometrial carcinoma are eligible for this study)

- The procedures may be performed via laparotomy or laparoscopy (including robot-assisted) as per the surgeon?s preference; the surgeon must record in the operative report whether a lymphadenectomy was performed (see link above to Surgical Procedures Manual) or not; a specific number of lymph nodes removed will not be utilized for eligibility, but the operative report should reflect that the procedure performed was consistent with the procedures described in the GOG Surgical Manual

- If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment computed tomography (CT)/magnetic resonance imaging (MRI) is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease); post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed

- For the purposes of description, patients will be staged according to the International Federation of Gynecology and Obstetrics (FIGO) 2009 staging system; eligibility is defined based on clinical-pathologic features; patients with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:

- Age >= 70 years with one risk factor

- Age >= 50 with 2 risk factors

- Age >= 18 years with 3 risk factors

- Risk factors: grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ? myometrial invasion; patients with these risk criteria may be enrolled with either positive or negative cytology

- Patients with stage II endometrial carcinoma (any histology) with cervical stromal invasion (occult or gross involvement), with or without high-intermediate risk factors

- Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement), and with peritoneal cytology negative for malignancy

- Patients must have GOG performance status 0, 1, or 2

- Absolute neutrophil count (ANC) >= 1,500/mcl (equivalent to Common Toxicity Criteria [CTCAE version [v] 3.0] grade 1)

- Platelets >= 100,000/mcl (CTCAE v3.0 grade 0-1)

- Serum creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0

- Note: If serum creatinine > ULN, a 24-hour creatinine clearance must be collected and must be > 50 mL/min

- Bilirubin =< 1.5 x ULN (CTCAE v3.0 grade 1)

- Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE grade 0-1)

- Alkaline phosphatase =< 2.5 x ULN (CTCAE grade 0-1)

- Neuropathy (sensory and motor) =< CTCAE v3.0 grade 1

- Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria

- Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

- Patients who have already received non-surgical therapy for endometrial cancer including chemotherapy, radiation (example, pre-operative or post-operative brachytherapy), hormonal or biologic therapy

- Patients identified with pathologically confirmed spread of cancer beyond the uterus and cervix to pelvic or para-aortic lymph nodes, adnexal structures, and/or other anatomic sites, or patients with serous or clear cell histology and with positive cytologic washings

- Patients with nodal (for patients who did not have nodal dissection performed) or distant disease determined based on imaging studies; patients with suspicious nodes that have been biopsied (re-staging operation, fine needle aspiration [FNA]) and are pathologically negative will be eligible

- 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 5 years; patients are excluded if their previous cancer treatment contraindicates this protocol therapy; specifically, patients who have received prior radiotherapy directed to treat disease within the abdominal cavity or pelvis are excluded

- Prior radiation of localized cancer of the breast, head and neck, thyroid, or skin is permitted, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease

- Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease

- Patients who have contraindications to pelvic radiation therapy (RT) (e.g. pelvic kidney, connective tissue disease, inflammatory bowel disease, etc.) should be screened in advance and not be considered eligible for the trial

- Patients with recurrent endometrial cancer

- Patients with surgical or clinical, FIGO 2009 stage III or IV endometrial carcinoma

- Patients with non-epithelial uterine malignancies such as uterine carcinosarcoma or leiomyosarcoma

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
3-Dimensional Conformal Radiation Therapy
Undergo pelvic radiation therapy
Drug:
Carboplatin
Given IV
Radiation:
Intensity-Modulated Radiation Therapy
Undergo pelvic radiation therapy
Internal Radiation Therapy
Undergo vaginal cuff brachytherapy
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Paclitaxel
Given IV
Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
Korea, Republic of Inha University Jung-gu Incheon
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Korea Cancer Center Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Yongdong Severence Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon
United States Pali Momi Medical Center 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Abington Memorial Hospital Abington Pennsylvania
United States Cleveland Clinic Akron General Akron Ohio
United States Summa Akron City Hospital/Cooper Cancer Center Akron Ohio
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 McFarland Clinic PC - Ames Ames Iowa
United States Providence Alaska Medical Center Anchorage Alaska
United States AnMed Health Cancer Center Anderson South Carolina
United States AnMed Health Hospital Anderson South Carolina
United States Northern Virginia Pelvic Surgery Associates Annandale Virginia
United States Hospital District Sixth of Harper County Anthony Kansas
United States Texas Oncology-Arlington South Arlington Texas
United States Randolph Hospital Asheboro North Carolina
United States Hope Women's Cancer Centers-Asheville Asheville North Carolina
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Grady Health System Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States Augusta University Medical Center Augusta Georgia
United States Colorado Gynecologic Oncology Group Aurora Colorado
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States The Medical Center of Aurora Aurora Colorado
United States University of Colorado Hospital Aurora Colorado
United States Texas Oncology - Central Austin Cancer Center Austin Texas
United States Texas Oncology - South Austin Cancer Center Austin Texas
United States Texas Oncology-Austin Midtown Austin Texas
United States Greater Baltimore Medical Center Baltimore Maryland
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States Saint Agnes Hospital Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Summa Barberton Hospital Barberton Ohio
United States Woman's Hospital Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Texas Oncology Bedford Bedford Texas
United States Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana
United States PeaceHealth Medical Group PC Bellingham Washington
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Saint Joseph Medical Center Bloomington Illinois
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Tufts Medical Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Harrison Medical Center Bremerton Washington
United States Saint Vincent's Medical Center Bridgeport Connecticut
United States Island Gynecologic Oncology Brightwaters 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 Lahey Hospital and Medical Center Burlington Massachusetts
United States University of Vermont Medical Center Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Cooper Hospital University Medical Center Camden New Jersey
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Sands Cancer Center Canandaigua New York
United States Aultman Health Foundation Canton Ohio
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Mercy San Juan Medical Center Carmichael California
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North 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 Gynecological Oncology Chattanooga Tennessee
United States Chattanooga's Program in Women's Oncology Chattanooga Tennessee
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States University of Cincinnati/Barrett Cancer 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 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
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 The Mark H Zangmeister Center Columbus Ohio
United States Atrium Health Cabarrus/LCI-Concord Concord North Carolina
United States John Muir Medical Center-Concord Campus Concord California
United States Mercy Hospital Coon Rapids Minnesota
United States Baylor University Medical Center Dallas Texas
United States Clements University Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Danbury Hospital Danbury Connecticut
United States Geisinger Medical Center Danville Pennsylvania
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Heartland Cancer Research NCORP Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
United States Texas Oncology-Denton South Denton Texas
United States Colorado Cancer Research Program NCORP Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital 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 Medical Center - Des Moines Des Moines Iowa
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 Duke University Medical Center Durham North Carolina
United States Franciscan Saint Margaret Health-Dyer Campus Dyer Indiana
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 Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Union Hospital of Cecil County Elkton Maryland
United States Swedish Medical Center Englewood Colorado
United States Willamette Valley Cancer Center Eugene Oregon
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Roger Maris Cancer Center Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Clinic North-Fargo Fargo North Dakota
United States University of Connecticut Farmington Connecticut
United States Blanchard Valley Hospital Findlay Ohio
United States Holy Cross Hospital Fort Lauderdale Florida
United States Florida Gynecologic Oncology Fort Myers Florida
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Parkview Hospital Randallia Fort Wayne Indiana
United States Radiation Oncology Associates PC Fort Wayne Indiana
United States Baylor All Saints Medical Center at Fort Worth Fort Worth Texas
United States The Klabzuba Cancer Center Fort Worth Texas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States New York Hospital Medical Center of Queens Fresh Meadows New York
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland Idaho
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States University of Texas Medical Branch Galveston Texas
United States Adams Cancer Center Gettysburg Pennsylvania
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
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 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 North Colorado Medical Center Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Cone Health Cancer Center Greensboro North Carolina
United States Greenville Health System Cancer Institute-Andrews Greenville South Carolina
United States Greenville Health System Cancer Institute-Butternut Greenville South Carolina
United States Greenville Health System Cancer Institute-Eastside Greenville South Carolina
United States Greenville Health System Cancer Institute-Faris Greenville South Carolina
United States Greenville Memorial Hospital Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Greenville Health System Cancer Institute-Greer Greer South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Franciscan Saint Margaret Health-Hammond Campus Hammond Indiana
United States Cherry Tree Cancer Center Hanover Pennsylvania
United States Hartford Hospital Hartford Connecticut
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois
United States Sudarshan K Sharma MD Limited-Gynecologic Oncology Hinsdale Illinois
United States Hawaii Cancer Care Inc-POB II Honolulu Hawaii
United States Hawaii Oncology Inc-Kuakini Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children 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 M D Anderson Cancer Center Houston Texas
United States Memorial Hermann Memorial City Medical Center Houston Texas
United States The Methodist Hospital System Houston Texas
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States IU Health Central Indiana Cancer Centers-East 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 University of Mississippi Medical Center Jackson Mississippi
United States Southeast Gynecologic Oncology Associates Jacksonville Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States North Kansas City Hospital 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 The University of Kansas Cancer Center-North Kansas City Missouri
United States Truman Medical Center Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States Kettering Medical Center Kettering Ohio
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States University of Tennessee - Knoxville Knoxville Tennessee
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States UC San Diego Moores Cancer Center La Jolla California
United States IU Health La Porte Hospital La Porte Indiana
United States Wilford Hall Medical Center Lackland Air Force Base Texas
United States Northwell Health NCORP Lake Success New York
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Saint Anthony Hospital Lakewood Colorado
United States Lancaster General Hospital Lancaster Pennsylvania
United States Memorial Medical Center - Las Cruces Las Cruces New Mexico
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Beebe Medical Center Lewes Delaware
United States Baptist Health Lexington Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Southwest Medical Center Liberal Kansas
United States Liberty Radiation Oncology Center Liberty Missouri
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Saint Barnabas Medical Center Livingston New Jersey
United States Sky Ridge Medical Center Lone Tree Colorado
United States Long Beach Memorial Medical Center-Todd Cancer Institute Long Beach California
United States Monmouth Medical Center Long Branch New Jersey
United States Longmont United Hospital Longmont Colorado
United States Texas Oncology-Longview Cancer Center Longview Texas
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 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Central Georgia Gynecologic Oncology Macon Georgia
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Elliot Hospital Manchester New Hampshire
United States North Shore University Hospital Manhasset New York
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Loyola University Medical Center Maywood Illinois
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Columbia Saint Mary's Hospital - Ozaukee Mequon Wisconsin
United States Saint Luke's Mountain States Tumor Institute - Meridian Meridian Idaho
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Orange Regional Medical Center Middletown New York
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Columbia Saint Mary's Water Tower Medical Commons Milwaukee Wisconsin
United States Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin
United States NYU Winthrop Hospital Mineola New York
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States University of South Alabama Mitchell Cancer Institute Mobile Alabama
United States Memorial Medical Center Modesto California
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 Skagit Valley Hospital Regional Cancer Care Center Mount Vernon Washington
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States The Community Hospital Munster Indiana
United States Intermountain Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States Saint Luke's Mountain States Tumor Institute - Nampa Nampa Idaho
United States Meharry Medical College Nashville Tennessee
United States Tennessee Oncology PLLC- Centennial Medical Center 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 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital 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 University Medical Center New Orleans New Orleans Louisiana
United States New Ulm Medical Center New Ulm Minnesota
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 Mount Sinai Union Square New York New York
United States Mount Sinai West 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 Licking Memorial Hospital Newark Ohio
United States Rutgers New Jersey Medical School Newark New Jersey
United States Cancer Center of Kansas - Newton Newton Kansas
United States Lakeland Hospital Niles Niles Michigan
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
United States William Backus Hospital Norwich Connecticut
United States Advocate Christ Medical Center Oak Lawn Illinois
United States Kaiser Permanente Oakland-Broadway Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States West Texas Cancer Center Odessa Texas
United States McKay-Dee Hospital Center Ogden Utah
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Florida Hospital Orlando Orlando Florida
United States Florida Institute of Research Medicine and Surgery-Cancer Center Orlando Florida
United States UF Cancer Center at Orlando Health Orlando Florida
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
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 Saint Luke's South Hospital Overland Park Kansas
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 Parker Adventist Hospital Parker Colorado
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Singing River Hospital Pascagoula Mississippi
United States Illinois CancerCare-Peoria Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Valley Radiation Oncology Peru Illinois
United States Fox Chase Cancer Center 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 Saint Luke's Hospital-Warren Campus Phillipsburg New Jersey
United States Saint Joseph's Hospital and Medical Center Phoenix Arizona
United States Pikeville Medical Center Pikeville Kentucky
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Compass Oncology Rose Quarter 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 Southern Ohio Medical Center Portsmouth Ohio
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Kansas City NCI Community Oncology Research Program Prairie Village Kansas
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Women and Infants Hospital Providence Rhode Island
United States Utah Valley Regional Medical Center Provo Utah
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Wheaton Franciscan Cancer Care - All Saints Racine Wisconsin
United States Duke Raleigh Hospital Raleigh North Carolina
United States Duke Women's Cancer Care Raleigh Raleigh North Carolina
United States Black Hills Obstetrics and Gynecology Rapid City South Dakota
United States Kaiser Permanente-Redwood City Redwood City California
United States Spectrum Health Reed City Hospital Reed City Michigan
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 Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Valley Hospital Ridgewood New Jersey
United States Carilion Clinic Gynecological Oncology Roanoke Virginia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Highland Hospital Rochester New York
United States University of Rochester Rochester New York
United States University Radiation Oncology Rochester New York
United States Swedish American Hospital Rockford Illinois
United States Rohnert Park Cancer Center Rohnert Park California
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-Roseville Roseville California
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States Texas Oncology - Round Rock Cancer Center Round Rock Texas
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Rutherford Hospital Rutherfordton North Carolina
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Mercy General Hospital Radiation Oncology Center Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
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 Marie Yeager Cancer Center Saint Joseph Michigan
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Saint Louis-Cape Girardeau CCOP 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 Park Nicollet Frauenshuh Cancer Center Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Women's Cancer Associates Saint Petersburg Florida
United States Salem Hospital Salem Oregon
United States UH Seidman Cancer Center at Salem Regional Medical Center Salem Ohio
United States Cancer Center of Kansas - Salina Salina Kansas
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 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 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 Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Memorial Health University Medical Center Savannah Georgia
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Kaiser Permanente Washington Seattle Washington
United States Northwest Hospital Seattle Washington
United States Pacific Gynecology Specialists Seattle Washington
United States Seattle Cancer Care Alliance Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States Olympic Medical Cancer Care Center Sequim Washington
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Texas Cancer Center-Sherman Sherman Texas
United States Louisiana State University Health Sciences Center Shreveport Shreveport Louisiana
United States Avera Cancer Institute Sioux Falls South Dakota
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 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 Kaiser Permanente-South San Francisco South San Francisco California
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Spartanburg Medical Center Spartanburg South Carolina
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Rockwood Cancer Treatment Center-DHEC-Downtown Spokane Washington
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 Springfield Regional Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Stony Brook University Medical Center Stony Brook New York
United States Texas Oncology Cancer Center Sugar Land Sugar Land Texas
United States Aurora Medical Center in Summit Summit Wisconsin
United States Overlook Hospital Summit New Jersey
United States Olive View-University of California Los Angeles Medical Center Sylmar California
United States State University of New York Upstate Medical University Syracuse New York
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States North Suburban Medical Center Thornton Colorado
United States Community Medical Center Toms River New Jersey
United States Munson Medical Center Traverse City Michigan
United States Upper Valley Medical Center Troy Ohio
United States Arizona Oncology Associates-West Orange Grove Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Tyler Cancer Center Tyler Texas
United States Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
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 Maui Memorial Medical Center Wailuku Hawaii
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States John Muir Medical Center-Walnut Creek Walnut Creek California
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States MedStar Washington Hospital Center Washington District of Columbia
United States Sibley Memorial Hospital Washington District of Columbia
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Wenatchee Valley Hospital and Clinics Wenatchee Washington
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia
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 Via Christi Regional Medical Center Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Texas Oncology-Wichita Falls Texoma Cancer Center Wichita Falls Texas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Northwestern Medicine Central DuPage Hospital Winfield Illinois
United States Southeast Clinical Oncology Research (SCOR) Consortium NCORP Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Cancer Treatment Center Wooster Ohio
United States University of Massachusetts Medical School Worcester Massachusetts
United States University of Massachusetts Memorial Health Care 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 Cancer Institutes of Washington PLLC Yakima Washington
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States WellSpan Health-York Cancer Center York Pennsylvania
United States WellSpan Health-York Hospital York Pennsylvania
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Gene Expression Based Risk Score Baseline
Primary Number of Participants With Recurrence or Death Events at Primary Analysis Recurrence-Free Survival is the period from study entry until disease recurrence, death, or date of last contact Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years
Secondary Number of Participants With Death Events The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study. Overall survival is measured from study enrollment for up to 10 years.
Secondary Number of Participants With Sites of Recurrence Three competing risk analyses were carried out for three different types of recurrences: 1) any vaginal, 2) any pelvic or any PA nodes and 3) any distant. More than one type of recurrence can be counted for an individual patient. A death prior to a specific type of recurrence was considered a competing event. Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years
Secondary Patient Reported Fatigue Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was 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 scale. The FACIT-Fatigue score ranges 0-52 with a large score suggests less fatigue. Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment
Secondary Patient-reported Neurotoxicity Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was 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 scale. The Ntx score ranges 0-16 with a large score suggesting less neurotoxicity. Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.
Secondary Patient-reported Quality of Life Patient reported quality of life as measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item in the FACT-En TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The FACT-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment
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