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Brief Title: Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
Official Title: The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients
Study ID: NCT00956670
Brief Summary: 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.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Gynecologic Oncology Group of Arizona, Phoenix, Arizona, United States
Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Mayo Clinic Hospital, Phoenix, Arizona, United States
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Sutter Auburn Faith Hospital, Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States
Mills - Peninsula Hospitals, Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, United States
Sutter Davis Hospital, Davis, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Kaiser Permanente Los Angeles 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-Camino Division, Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, United States
Sutter Cancer Research Consortium, Novato, California, United States
Palo Alto Medical Foundation Health Care, Palo Alto, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States
Sutter Roseville Medical Center, Roseville, California, United States
Sutter General Hospital, Sacramento, California, United States
California Pacific Medical Center-Pacific Campus, San Francisco, California, United States
Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, United States
Sutter Pacific Medical Foundation, Santa Rosa, California, United States
Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, 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
Sutter Solano Medical Center/Cancer Center, Vallejo, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Hartford Hospital, Hartford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC, Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Regional Hematology and Oncology PA, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
Augusta University Medical Center, Augusta, Georgia, United States
John B Amos Cancer Center, Columbus, Georgia, United States
Memorial University Medical Center, Savannah, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Kootenai Cancer Center, Post Falls, Idaho, United States
Carle on Vermilion, Danville, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
The Carle Foundation Hospital, Urbana, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States
Mercy Cancer Center-West Lakes, 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
Methodist West Hospital, West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes, West Des Moines, Iowa, 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
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal, Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, 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
Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Hematology/Oncology Clinic LLP, Baton Rouge, Louisiana, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Maine Medical Center-Bramhall Campus, Portland, Maine, United States
Maine Medical Center- Scarborough Campus, Scarborough, Maine, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Baystate Medical Center, Springfield, Massachusetts, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
Bronson Battle Creek, Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, United States
Beaumont Hospital-Dearborn, Dearborn, Michigan, United States
Saint John Hospital and Medical Center, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Hurley Cancer Institute, Flint, 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
Allegiance Health, Jackson, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
Lakeland Community Hospital, Niles, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Lake Huron Medical Center, Port Huron, Michigan, United States
Spectrum Health Reed City Hospital, Reed City, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
Saint Mary's of Michigan, Saginaw, Michigan, United States
Lakeland Hospital, Saint Joseph, Michigan, United States
Marie Yeager Cancer Center, Saint Joseph, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
William Beaumont Hospital - Troy, Troy, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, 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
Health Partners Inc, 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
Mayo Clinic, Rochester, 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
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
Saint Dominic-Jackson Memorial Hospital, Jackson, Mississippi, United States
Saint John's Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, 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
Billings Clinic Cancer Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Montana Cancer Consortium NCORP, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, 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
State University of New York Downstate Medical Center, Brooklyn, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Park Ridge Hospital Breast Health Center, Hendersonville, 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
Summa Akron City Hospital/Cooper Cancer Center, Akron, 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
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States
Lake University Ireland Cancer Center, Mentor, 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
Abington Memorial Hospital, Abington, Pennsylvania, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Geisinger Medical Group, State College, 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
Women and Infants Hospital, Providence, Rhode Island, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Saint Francis Hospital, Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Parkland Memorial Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Memorial Hermann Texas Medical Center, Houston, Texas, United States
Scott and White Memorial Hospital, Temple, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
Rocky Mountain Oncology, Casper, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Name: Richard Barakat
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR