Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
NCT ID: NCT00807768
Last Updated: 2019-03-20
Study Results
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View full resultsBasic Information
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UNKNOWN
PHASE3
601 participants
INTERVENTIONAL
2009-03-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (pelvic radiation therapy)
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.
3-Dimensional Conformal Radiation Therapy
Undergo pelvic radiation therapy
Intensity-Modulated Radiation Therapy
Undergo pelvic radiation therapy
Internal Radiation Therapy
Undergo vaginal cuff brachytherapy
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (brachytherapy, paclitaxel, carboplatin)
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 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.
Carboplatin
Given IV
Internal Radiation Therapy
Undergo vaginal cuff brachytherapy
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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3-Dimensional Conformal Radiation Therapy
Undergo pelvic radiation therapy
Carboplatin
Given IV
Intensity-Modulated Radiation Therapy
Undergo pelvic radiation therapy
Internal Radiation Therapy
Undergo vaginal cuff brachytherapy
Laboratory Biomarker Analysis
Correlative studies
Paclitaxel
Given IV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Marcus E Randall
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Long Beach Memorial Medical Center-Todd Cancer Institute
Long Beach, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Rohnert Park Cancer Center
Rohnert Park, California, 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
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Mercy General Hospital Radiation Oncology Center
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
Kaiser Permanente - Sacramento
Sacramento, 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
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
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, 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
Boulder Community Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Colorado Cancer Research Program NCORP
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Littleton Adventist Hospital
Littleton, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Parker Adventist Hospital
Parker, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States
Saint Vincent's Medical Center
Bridgeport, Connecticut, United States
Danbury Hospital
Danbury, Connecticut, United States
University of Connecticut
Farmington, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
William Backus Hospital
Norwich, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Florida Gynecologic Oncology
Fort Myers, Florida, United States
Southeast Gynecologic Oncology Associates
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 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
Women's Cancer Associates
St. Petersburg, Florida, United States
Grady Health System
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States
Central Georgia Gynecologic Oncology
Macon, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Maui Memorial Medical Center
Wailuku, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States
Saint Anthony's Health
Alton, Illinois, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Northwestern University
Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Heartland Cancer Research NCORP
Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Swedish American Hospital
Rockford, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, United States
Franciscan Saint Margaret Health-Dyer Campus
Dyer, Indiana, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, United States
Franciscan Saint Margaret Health-Hammond Campus
Hammond, 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
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
The Community Hospital
Munster, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Reid Health
Richmond, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
McFarland Clinic PC - Ames
Ames, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, 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
Iowa Lutheran Hospital
Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Hospital District Sixth of Harper County
Anthony, Kansas, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Saint Luke's South Hospital
Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
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
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Pikeville Medical Center
Pikeville, Kentucky, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States
Maine Medical Center-Bramhall Campus
Portland, Maine, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Saint Agnes Hospital
Baltimore, Maryland, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, 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
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Hospital Niles
Niles, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 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
New Ulm Medical Center
New Ulm, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 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
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Singing River Hospital
Pascagoula, Mississippi, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Truman Medical Center
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Joseph Health Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
The University of Kansas Cancer Center-North
Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center
Liberty, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Montana Cancer Consortium NCORP
Billings, Montana, 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
Nebraska Methodist Hospital
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Center of Hope at Renown Medical Center
Reno, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Elliot Hospital
Manchester, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Virtua Memorial
Mount Holly, New Jersey, United States
Jersey Shore Medical Center
Neptune City, New Jersey, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Saint Luke's Hospital-Warren Campus
Phillipsburg, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
Inspira Medical Center Vineland
Vineland, New Jersey, United States
Virtua Voorhees
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, United States
Women's Cancer Care Associates LLC
Albany, New York, United States
Island Gynecologic Oncology
Brightwaters, New York, United States
State University of New York Downstate Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Sands Cancer Center
Canandaigua, New York, United States
New York Hospital Medical Center of Queens
Fresh Meadows, New York, United States
Northwell Health NCORP
Lake Success, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Orange Regional Medical Center
Middletown, New York, United States
NYU Winthrop Hospital
Mineola, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Mount Sinai Union Square
New York, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Mount Sinai West
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
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Highland Hospital
Rochester, New York, United States
University Radiation Oncology
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, 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
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, United States
Duke Raleigh Hospital
Raleigh, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, 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
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
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Summa Barberton Hospital
Barberton, Ohio, United States
Aultman Health Foundation
Canton, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 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
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, 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
Grady Memorial Hospital
Delaware, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
UH Seidman Cancer Center at Salem Regional Medical Center
Salem, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Compass Oncology Rose Quarter
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Salem Hospital
Salem, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, United States
WellSpan Health-York Cancer Center
York, Pennsylvania, United States
WellSpan Health-York Hospital
York, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
AnMed Health Hospital
Anderson, South Carolina, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Chattanooga Gynecological Oncology
Chattanooga, Tennessee, United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, United States
Tennessee Oncology PLLC- Centennial Medical Center
Nashville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Texas Oncology-Arlington South
Arlington, Texas, United States
Texas Oncology-Austin Midtown
Austin, Texas, United States
Texas Oncology - Central Austin Cancer Center
Austin, Texas, United States
Texas Oncology - South Austin Cancer Center
Austin, Texas, United States
Texas Oncology Bedford
Bedford, Texas, 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
Texas Oncology-Denton South
Denton, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, United States
The Klabzuba Cancer Center
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
The Methodist Hospital System
Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Texas Oncology-Longview Cancer Center
Longview, Texas, United States
West Texas Cancer Center
Odessa, Texas, United States
Texas Oncology - Round Rock Cancer Center
Round Rock, Texas, United States
Texas Cancer Center-Sherman
Sherman, Texas, United States
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology-Wichita Falls Texoma Cancer Center
Wichita Falls, Texas, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Intermountain Health Care
Salt Lake City, Utah, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States
PeaceHealth Medical Group PC
Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States
Harrison Medical Center
Bremerton, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Kaiser Permanente Washington
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Northwest Hospital
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Olympic Medical Cancer Care Center
Sequim, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 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
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Wheaton Franciscan Cancer Care - All Saints
Racine, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Inha University
Jung-gu, Incheon, South Korea
Asan Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Yongdong Severence Hospital
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Countries
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References
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Randall ME, Filiaci V, McMeekin DS, von Gruenigen V, Huang H, Yashar CM, Mannel RS, Kim JW, Salani R, DiSilvestro PA, Burke JJ, Rutherford T, Spirtos NM, Terada K, Anderson PR, Brewster WR, Small W, Aghajanian CA, Miller DS. Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer. J Clin Oncol. 2019 Jul 20;37(21):1810-1818. doi: 10.1200/JCO.18.01575. Epub 2019 Apr 17.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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NCI-2009-00610
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000629591
Identifier Type: -
Identifier Source: secondary_id
GOG-0249
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0249
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0249
Identifier Type: -
Identifier Source: org_study_id
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