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Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02315469
Recruitment Status : Active, not recruiting
First Posted : December 11, 2014
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Brief Summary:
This research trial studies comprehensive patient questionnaires in predicting complications in older patients with gynecologic cancer undergoing surgery. Comprehensive patient questionnaires completed before surgery may help identify complications, such as the need for assistance in taking medications, decreased mobility, decreased social activity, and falls, and may improve outcomes for older patients with gynecologic cancer.

Condition or disease Intervention/treatment
Endometrial Serous Adenocarcinoma Fallopian Tube Carcinoma Ovarian Carcinoma Primary Peritoneal Carcinoma Stage IIIA Uterine Corpus Cancer AJCC v7 Stage IIIB Uterine Corpus Cancer AJCC v7 Stage IIIC Uterine Corpus Cancer AJCC v7 Stage IVA Uterine Corpus Cancer AJCC v7 Stage IVB Uterine Corpus Cancer AJCC v7 Other: Comprehensive Geriatric Assessment Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether the preoperative geriatric assessment (GA)-gynecology (GYN) score will be associated with major post-operative complications in elderly patients undergoing open primary cytoreduction surgery.

SECONDARY OBJECTIVES:

I. To explore associations between individual variables of the preoperative geriatric assessment and major post-operative complications in patients undergoing open primary cytoreduction surgery.

II. To assess the association between the preoperative GA-GYN score and cytoreducibility defined by extent of residual disease in patients undergoing open primary cytoreduction surgery.

TERTIARY OBJECTIVES :

I. To evaluate whether the preoperative GA-GYN scores obtained before and after neoadjuvant chemotherapy will be associated with major postoperative complications in elderly patients undergoing open interval cytoreduction surgery.

II. To describe reasons why surgeons at centers where open cytoreduction surgery is the standard of care choose to perform interval surgery vs primary surgery, and to explore the association of the preoperative GA-GYN score with the decision to perform primary surgery or interval surgery or no surgery.

III. To collect the following specific information on how elderly women with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma are treated at centers that consider open cytoreduction surgery the standard of care: (1) the percentage of patients treated with primary open cytoreduction vs. interval open cytoreduction vs. no surgery and (2) to ascertain the extent of cytoreduction.

IV. To determine whether neoadjuvant chemotherapy will be associated with changes in the GA-GYN score to change by comparing the GA-GYN scores obtained before and after neoadjuvant chemotherapy.

V. To determine whether 30-day readmission rates after cytoreductive surgery correlate with the GA-GYN score.

OUTLINE:

At time of consent and within 14 days of surgery, patients complete a pre-operative geriatric assessment that evaluates functional status, comorbid medical conditions, psychological state, social support, and nutritional status. Post-operative complications are also collected for 6 weeks after surgery or until the date patients initiate or restart chemotherapy whichever is first.


Layout table for study information
Study Type : Observational
Actual Enrollment : 190 participants
Official Title: Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers
Actual Study Start Date : February 10, 2015
Actual Primary Completion Date : March 15, 2016


Group/Cohort Intervention/treatment
Observational (geriatric assessment)
At time of consent and within 14 days of surgery, patients complete a pre-operative geriatric assessment that evaluates functional status, comorbid medical conditions, psychological state, social support, and nutritional status. Post-operative complications are also collected for 6 weeks after surgery or until the date patients initiate or restart chemotherapy whichever is first.
Other: Comprehensive Geriatric Assessment
Complete pre-operative geriatric assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. GA-GYN score, defined as the summation of the risk score for each risk factor derived from the predictive model including 5 risk factors from the GA and 3 other risk factors [ Time Frame: Up to 14 days before surgery ]
    Geriatric assessment variables are used in the predictive model; the risk factors will be used to derive the total score.

  2. Occurrence of major post-operative complications outlined in The American College of Surgeons? National Surgical Quality Improvement Program [ Time Frame: Up to 6 weeks after surgery ]

Secondary Outcome Measures :
  1. Comorbidity, as measured by the Older American Resources and Services (OARS) Physical Health section [ Time Frame: Up to 14 days before surgery ]
    The OARS Physical Health Section is a comorbidity scale that contains a list of current illnesses and conditions an individual might have, and the degree to which they impair daily activities, rated on a 3-point scale of ? not at all? to ? a great deal.?

  2. Extent of residual disease in patients undergoing open primary cytoreduction surgery [ Time Frame: 6 weeks after surgery ]
    The association between the preoperative GA-GYN score and cytoreducibility defined by extent of residual disease in patients undergoing open primary cytoreduction surgery will be assessed. Cytoreducibility is defined as complete cytoreduction (maximum dimension of residual disease =< 0.1 cm), optimal cytoreduction (maximum dimension of residual disease greater than 0.1 cm but less than or equal to 1.0 cm), or suboptimal cytoreduction (maximum dimension of residual disease greater than 1.0 cm) according to extent of residual disease.

  3. Functional status, as measured by Activities of Daily Living (ADL) [ Time Frame: Up to 14 days before surgery ]
    The ALD uses a subscale of the Medical Outcomes Study physical health with 10 questions rated on a 3-point scale.

  4. Functional status, as measured by Instrumental Activities of Daily Living (IADL) [ Time Frame: Up to 14 days before surgery ]
    The IADL subscale consists of 7 questions rated on a 3-point Likert scale measuring the degree to which an activity can be performed independently.

  5. Number of falls in last 6 months [ Time Frame: Up to 14 days before surgery ]
  6. Nutritional status, as measured by BMI [ Time Frame: Up to 14 days before surgery ]
  7. Nutritional status, as measured by percentage unintentional weight loss in last 6 months [ Time Frame: Up to 14 days before surgery ]
  8. Patient?s overall functioning, as measured by the physician rated performance rating scale [ Time Frame: Up to 14 days before surgery ]
  9. Patient?s overall functioning, as measured by the self-reported performance rating scale [ Time Frame: Up to 14 days before surgery ]
  10. Psychological status, as measured by the Mental Health Inventory (MHI) that is based upon the General Well-Being Scale [ Time Frame: Up to 14 days before surgery ]
    The full length MHI consists of 38 items grouped into the following five subscales and three global scores: anxiety, depression, general positive affect, emotional ties, and loss of behavioral emotional control, Psychological Distress (negative affect), Psychological Well-Being (positive affect), and the MHI total score a 17 item version of the MHI will be used, which will yield three global scores of Psychological Distress, Psychological Well-Being and MHI total score, as in the original 38 item MHI.

  11. Social functioning, as measured by the Medical Outcomes Study (MOS) Social Activity Limitations Measure [ Time Frame: Up to 14 days before surgery ]
    The four-item subscale identifies the extent to which physical or emotional problems interfere with an individual's social activities. All items are rated on a 5-point Likert scale, with response categories varying in each item. The mean of the total score is transformed to a scale of 0?100, with a higher number indicating greater support.

  12. Social support, as measured by the MOS Social Support Survey [ Time Frame: Up to 14 days before surgery ]

Other Outcome Measures:
  1. 30-day readmission after cytoreduction surgery [ Time Frame: Up to 30 days after surgery ]
    Will explore the correlation between pre-surgery GA-GYN score and dichotomized 30-day readmission.

  2. Frequency of patients treated with primary cytoreduction, interval cytoreduction, no surgery and the extent of surgery [ Time Frame: 6 weeks after surgery ]
  3. Frequency of reasons why surgeons perform interval surgery vs primary surgery and preoperative GA-GYN score [ Time Frame: 6 weeks after surgery ]
  4. Preoperative GA-GYN scores obtained before and after neoadjuvant chemotherapy [ Time Frame: Up to 14 days before surgery ]


Information from the National Library of Medicine

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


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

Inclusion Criteria:

  • Patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status; this clinical determination is made by the treating physician
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients who can understand sufficiently to be able to respond to questions posed by the study instruments
  • Patients and/or caregiver (durable power of attorney) can give consent and caregiver can assist with the responses to questionnaire

    • NOTE: it is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study; eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all
  • Post-operative pathology will not exclude patients from this study

Exclusion Criteria:

  • Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
  • Patients who would have planned surgery performed by the minimally invasive technique; institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study; the minimally invasive surgery (MIS) technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers
  • Patients who receive chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded
  • Patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315469


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Locations
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United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, Alaska
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
United States, Arizona
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
United States, California
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
Kaiser Permanente-Fremont
Fremont, California, United States, 94538
Kaiser Permanente
Fresno, California, United States, 93720
Kaiser Permanente-Irvine
Irvine, California, United States, 92618
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Kaiser Permanente-Modesto
Modesto, California, United States, 95356
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Kaiser Permanente-Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente-Richmond
Richmond, California, United States, 94801
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Kaiser Permanente San Leandro
San Leandro, California, United States, 94577
Kaiser Permanente-San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente-Stockton
Stockton, California, United States, 95210
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States, 91342
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States, 95688
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States, 94598
United States, Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States, 80012
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States, 80220
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program NCORP
Denver, Colorado, United States, 80222
Mercy Medical Center
Durango, Colorado, United States, 81301
Southwest Oncology PC
Durango, Colorado, United States, 81301
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States, 80113
Swedish Medical Center
Englewood, Colorado, United States, 80113
Mountain Blue Cancer Care Center
Golden, Colorado, United States, 80401
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, United States, 80111
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States, 80228
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States, 80124
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, United States, 81008
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States, 80260
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Florida
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, United States, 33805
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Memorial University Medical Center
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
United States, Idaho
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States, 83619
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States, 83686
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Memorial Hospital of Carbondale
Carbondale, Illinois, United States, 62902
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Radiation Oncology of Northern Illinois
Ottawa, Illinois, United States, 61350
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Springfield Clinic
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States, 62226
United States, Indiana
Michiana Hematology Oncology PC-Crown Point
Crown Point, Indiana, United States, 46307
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States, 46391
United States, Iowa
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States, 51503
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67905
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Flaget Memorial Hospital
Bardstown, Kentucky, United States, 40004
Baptist Health Corbin
Corbin, Kentucky, United States, 40701
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, United States, 40701
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States, 41017
Hardin Memorial Hospital
Elizabethtown, Kentucky, United States, 42701
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, United States, 40504
Saint Joseph Hospital East
Lexington, Kentucky, United States, 40509
Jewish Hospital
Louisville, Kentucky, United States, 40202
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, United States, 40215
Jewish Hospital Medical Center Northeast
Louisville, Kentucky, United States, 40245
Baptist Health Madisonville/Merle Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
Baptist Health Paducah
Paducah, Kentucky, United States, 42003
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, United States, 40165
United States, Maine
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Michigan
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Lakeland Community Hospital
Niles, Michigan, United States, 49120
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Lakeland Hospital
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Saint Dominic-Jackson Memorial Hospital
Jackson, Mississippi, United States, 39216
United States, Missouri
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States, 63628
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States, 63127
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59804
United States, Nebraska
CHI Health Saint Francis
Grand Island, Nebraska, United States, 68803
Heartland Hematology and Oncology
Kearney, Nebraska, United States, 68845
CHI Health Good Samaritan
Kearney, Nebraska, United States, 68847
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Hematology and Oncology Consultants PC
Omaha, Nebraska, United States, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States, 68130
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Midlands Community Hospital
Papillion, Nebraska, United States, 68046
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
Wentworth-Douglass Hospital
Dover, New Hampshire, United States, 03820
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Overlook Hospital
Summit, New Jersey, United States, 07902
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States, 87106
United States, New York
Women's Cancer Care Associates LLC
Albany, New York, United States, 12208
Montefiore Medical Center-Einstein Campus
Bronx, New York, United States, 10461
Montefiore Medical Center-Weiler Hospital
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan Kettering Sleepy Hollow
Sleepy Hollow, New York, United States, 10591
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States, 44122
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, United States, 45202
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, United States, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, United States, 45255
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Delaware Radiation Oncology
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
OhioHealth Marion General Hospital
Marion, Ohio, United States, 43302
Ireland Cancer Center Landerbrook Health Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Newark Radiation Oncology
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
University Hospitals Sharon Health Center
Wadsworth, Ohio, United States, 44281
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States, 17837
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States, 17901
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States, 29601
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, United States, 37343
Memorial GYN Plus
Ooltewah, Tennessee, United States, 37363
United States, Texas
Dell Seton Medical Center at The University of Texas
Austin, Texas, United States, 78701
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
United States, Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, United States, 84003
Sandra L Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Logan Regional Hospital
Logan, Utah, United States, 84321
Intermountain Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Washington
MultiCare Auburn Medical Center
Auburn, Washington, United States, 98001
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington, United States, 98110
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Harrison Medical Center
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Saint Elizabeth Hospital
Enumclaw, Washington, United States, 98022
Virginia Mason Federal Way Medical Center
Federal Way, Washington, United States, 98002
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Tacoma/Valley Radiation Oncology Centers-Gig Harbor
Gig Harbor, Washington, United States, 98332
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, United States, 98335
Northwest Cancer Clinic
Kennewick, Washington, United States, 99336
Saint Clare Hospital
Lakewood, Washington, United States, 98499
Virginia Mason Lynnwood Medical Center
Lynnwood, Washington, United States, 98036
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Peninsula Cancer Center
Poulsbo, Washington, United States, 98370
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States, 98372
Tacoma/Valley Radiation Oncology Centers-Puyallup
Puyallup, Washington, United States, 98372
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Tacoma/Valley Radiation Oncology Centers-Jackson Hall
Tacoma, Washington, United States, 97405
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, United States, 98405
MultiCare Tacoma General Hospital
Tacoma, Washington, United States, 98405
Northwest Medical Specialties PLLC
Tacoma, Washington, United States, 98405
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States, 98405
Tacoma/Valley Radiation Oncology Centers-Saint Joe's
Tacoma, Washington, United States, 98405
United States, West Virginia
Monongalia Hospital
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
United States, Wyoming
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, United States, 82001
Big Horn Basin Cancer Center
Cody, Wyoming, United States, 82414
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Canada, Quebec
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Amina Ahmed NRG Oncology

Layout table for additonal information
Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT02315469     History of Changes
Other Study ID Numbers: NRG-CC002
NCI-2014-01376 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-ELD1301
NRG-CC002 ( Other Identifier: NRG Oncology )
NRG-CC002 ( Other Identifier: DCP )
NRG-CC002 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
UG1CA189867 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Adenocarcinoma
Uterine Neoplasms
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous