Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
NCT ID: NCT00956670
Last Updated: 2017-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1055 participants
INTERVENTIONAL
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Study of High Risk Factors
Undergo lymphedema assessment
Therapeutic Conventional Surgery
Undergo surgery
Therapeutic Laparoscopic Surgery
Undergo surgery
Therapeutic Lymphadenectomy
Undergo lymphadenectomy
Interventions
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Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Study of High Risk Factors
Undergo lymphedema assessment
Therapeutic Conventional Surgery
Undergo surgery
Therapeutic Laparoscopic Surgery
Undergo surgery
Therapeutic Lymphadenectomy
Undergo lymphadenectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Richard Barakat
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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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
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Hospital Saint Louis
St Louis, 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
Countries
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Other Identifiers
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NCI-2011-01932
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000646813
Identifier Type: -
Identifier Source: secondary_id
GOG-0244
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0244
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0244
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0244
Identifier Type: -
Identifier Source: org_study_id
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