Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer (LEG)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00956670
First received: August 8, 2009
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

This clinical trial studies lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer. Collecting information over time about how often lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer, cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the best treatment.


Condition Intervention
Lymphedema
Stage IA Cervical Cancer
Stage IA Uterine Corpus Cancer
Stage IA Vulvar Cancer
Stage IB Cervical Cancer
Stage IB Uterine Corpus Cancer
Stage IB Vulvar Cancer
Stage II Uterine Corpus Cancer
Stage II Vulvar Cancer
Stage IIA Cervical Cancer
Stage IIIA Vulvar Cancer
Stage IIIB Vulvar Cancer
Stage IIIC Vulvar Cancer
Stage IVB Vulvar Cancer
Procedure: Therapeutic Lymphadenectomy
Procedure: Therapeutic Conventional Surgery
Procedure: Therapeutic Laparoscopic Surgery
Procedure: Study of High Risk Factors
Other: Questionnaire Administration
Other: Quality-of-Life Assessment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Incidence of lymphedema, assessed through volumetric measurements using serial circumferential measurements performed from 10 cm above the heel to the inguinal crease at 10 cm intervals [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    A competing risks analysis will be required to estimate the cumulative incidence of lymphedema. Transition probabilities in the Markov Chain will be estimated by simple proportions, ignoring covariates, to address this primary objective. Confidence intervals for the cumulative incidence of lymphedema then will be computed using the Delta Method, utilizing the fact that the transition proportions have and asymptotic multivariate normal distribution.

  • Risk factors for the development of lower extremity lymphoma in patients with endometrial cancers [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically. The predictive power of the models for these rates will be assessed.


Secondary Outcome Measures:
  • Risk factors for the development of lower extremity lymphoma in patients with cervical cancers [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically. The predictive power of the models for these rates will be assessed.

  • Quality of life [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    As measured by the FACT QOL scale, psychological adjustment as measured by the Impact of Events Subscale (IES), and FACIT body image items, physical disability as measured by the Lower Extremity Functional Scale -(LEFS) and PROs of physical health status/function (sexual), as measured by FACT-FW; FACIT & PROMIS.

  • Patient self-reported symptoms [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored.


Estimated Enrollment: 1037
Study Start Date: June 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (lymphedema assessment)

Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014)

Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route.

Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling.

Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months.

Procedure: Therapeutic Lymphadenectomy
Undergo lymphadenectomy
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Procedure: Therapeutic Laparoscopic Surgery
Undergo surgery
Procedure: Study of High Risk Factors
Undergo lymphedema assessment
Other: Questionnaire Administration
Ancillary studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Detailed Description:

PRIMARY OBJECTIVES:

I. To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy with a concurrent lymphadenectomy for a gynecologic malignancy.

II. To identify risk factors for the development of lower extremity lymphedema following radical surgery among patients with any one of the three types of gynecologic malignancy studied and to develop a corresponding predictive model.

SECONDARY OBJECTIVES:

I. To identify the effect that lower extremity lymphedema has on quality of life (QOL) (as measured with Functional Assessment of Cancer Therapy - General [FACT-G] + disease specific subscale), psychological adjustment (as measured with Impact of Events Scale [IES] and Functional Assessment of Chronic Illness Therapy [FACIT] body image items) and physical disability (of lower extremity as measured with Lower Extremity Functional Scale [LEFS]) and physical function(as measured by FACT-Functional Wellbeing [FW] subscale, FACIT disease specific items & patient-reported outcomes measurement information system [PROMIS] items) and to investigate potential protective mechanisms (FACT-Social Wellbeing [SW] subscale and patient characteristics).

II. To explore if patient self-reported symptoms (as measured with the lymphedema [LE] Symptom Measure [Cancer Lymphedema Questionnaire (GCLQ)]) are associated with the development of lymphedema in patients undergoing radical surgery for gynecologic malignancy.

TERTIARY OBJECTIVES:

I. To explore the effect of moderate or severe lymphedema (primary endpoint) on QOL outcomes, as measured by the FACT-General (G) questionnaire.

OUTLINE:

Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014)

Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route.

Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling.

Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be registered into three distinct groupings, and each group will be analyzed as a separate study:

    • Patients who will undergo or have undergone hysterectomy/bilateral salpingo-oophorectomy (BSO) and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique for clinical stage I-II or surgical stage I-III uterine carcinoma, including those receiving postoperative adjuvant therapy; patients enrolling after surgery may have a pathologic stage of I-III OR
    • Patients who will undergo or have undergone radical hysterectomy or trachelectomy and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique for clinical stage IA-IIA cervical carcinoma, including those receiving postoperative adjuvant therapy OR
    • Patients with vulvar cancer who will undergo or have undergone definitive surgery for primary stage I-IV vulvar cancer who will or have received a radical vulvectomy or radical local excision with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy; patients who are going to receive multi-modality therapy (radiation +/-chemotherapy) after undergoing surgery are eligible; patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy; (note: enrollment of vulvar patients was closed on June 9, 2014; no vulvar patients will be enrolled after closure of this arm)
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must have a serum albumin level of >= 3.0 within 14 days of entry
  • Surgery must occur within 5 business days before study entry or within eight weeks after study entry

Exclusion Criteria:

  • Patients with any prior clinical history of lower extremity lymphedema
  • Patients who have a history of congestive heart failure, chronic renal disease, or chronic liver disease
  • Patients with a prior history of chronic lower extremity swelling
  • Patients with a Gynecologic Oncology Group (GOG) performance grade of 3 or 4
  • Patients with a history of other invasive malignancies if their previous cancer treatment included any of the surgical procedures
  • Patients who have had prior lower extremity vascular surgery (arterial or venous)
  • Patients who have had prior pelvic, abdominal, inguinal, or lower extremity radiation therapy
  • Patients who have had or are going to receive another elective surgery during the same operative event as their pelvic (cervical or uterine cancers) or inguinal (vulvar) lymphadenectomy
  • Vulvar patients, from June 9, 2014 on
  • Patients cannot be enrolled on the trial unless there is at least one person at the participating site who has been trained in performing limb measurements
  • Patients who do not undergo or have not undergone the lymphadenectomy portion of the procedure
  • Patients who enter the study and then undergo sentinel node biopsy without the intention of undergoing complete lymphadenectomy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956670

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Sutter Auburn Faith Hospital
Auburn, California, United States, 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Mills - Peninsula Hospitals
Burlingame, California, United States, 94010
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Sutter Davis Hospital
Davis, California, United States, 95616
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Memorial Medical Center
Modesto, California, United States, 95355
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
Sutter Cancer Research Consortium
Novato, California, United States, 94945
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States, 94301
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Sutter General Hospital
Sacramento, California, United States, 95816
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94118
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States, 95065
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Palo Atlo Medical Foundation-Sunnyvale
Sunnyvale, California, United States, 94806
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States, 91342
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States, 94589
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States, 19713
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Regional Hematology and Oncology PA
Newark, Delaware, United States, 19713
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Georgia Regents University Medical Center
Augusta, Georgia, United States, 30912
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
Memorial University Medical Center
Savannah, Georgia, United States, 31404
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
United States, Illinois
Carle on Vermilion
Danville, Illinois, United States, 61832
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
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
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
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, 67901
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
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 - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Hematology/Oncology Clinic LLP
Baton Rouge, Louisiana, United States, 70809
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Medical Center-Bramhall Campus
Portland, Maine, United States, 04102
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States, 49307
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48502
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, United States, 49546
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Lakeland Community Hospital
Niles, Michigan, United States, 49120
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
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
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
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
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Saint Dominic-Jackson Memorial Hospital
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Billings Clinic Cancer Center
Billings, Montana, United States, 59107
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
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States, 87106
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, United States, 88011
United States, New York
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, United States, 28792
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Mainline Health CCOP
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
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Richard Barakat NRG Oncology
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00956670     History of Changes
Other Study ID Numbers: GOG-0244, NCI-2011-01932, CDR0000646813, GOG-0244, GOG-0244, GOG-0244, U10CA101165, UG1CA189867
Study First Received: August 8, 2009
Last Updated: December 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphedema
Uterine Cervical Neoplasms
Uterine Neoplasms
Vulvar Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on March 31, 2015