Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer (LEG)
Lymphedema, Stage IA Cervical Cancer, Stage IA Uterine Corpus Cancer
About this trial
This is an interventional supportive care trial for Lymphedema
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Gynecologic Oncology Group of Arizona
- Saint Joseph's Hospital and Medical Center
- Mayo Clinic Hospital
- Mayo Clinic in Arizona
- University of Arizona Cancer Center-North Campus
- University of Arkansas for Medical Sciences
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick Campus
- Mills - Peninsula Hospitals
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Sutter Davis Hospital
- City of Hope Comprehensive Cancer Center
- Kaiser Permanente Los Angeles Medical Center
- UCLA / Jonsson Comprehensive Cancer Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Palo Alto Medical Foundation Health Care
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Sutter General Hospital
- California Pacific Medical Center-Pacific Campus
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Palo Alto Medical Foundation-Sunnyvale
- Olive View-University of California Los Angeles Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Sutter Solano Medical Center/Cancer Center
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- The Hospital of Central Connecticut
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Regional Hematology and Oncology PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Christiana Care Health System-Wilmington Hospital
- Emory University Hospital Midtown
- Emory University/Winship Cancer Institute
- Augusta University Medical Center
- John B Amos Cancer Center
- Memorial University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Alphonsus Cancer Care Center-Boise
- Kootenai Cancer Center
- Carle on Vermilion
- Carle Physician Group-Effingham
- Carle Physician Group-Mattoon/Charleston
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- Saint Vincent Hospital and Health Care Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Via Christi Regional Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Hematology/Oncology Clinic LLP
- Tulane University Health Sciences Center
- Maine Medical Center-Bramhall Campus
- Maine Medical Center- Scarborough Campus
- Union Hospital of Cecil County
- Baystate Medical Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium NCORP
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Beaumont Hospital-Dearborn
- Saint John Hospital and Medical Center
- Hurley Medical Center
- Genesys Hurley Cancer Institute
- Cancer Research Consortium of West Michigan NCORP
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Allegiance Health
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Mercy Health Mercy Campus
- Lakeland Community Hospital
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- William Beaumont Hospital-Royal Oak
- Saint Mary's of Michigan
- Lakeland Hospital
- Marie Yeager Cancer Center
- Munson Medical Center
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview-Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- University of Minnesota/Masonic Cancer Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Saint Dominic-Jackson Memorial Hospital
- Saint John's Clinic-Rolla-Cancer and Hematology
- Mercy Hospital Saint Louis
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Women's Cancer Center of Nevada
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- Memorial Medical Center - Las Cruces
- State University of New York Downstate Medical Center
- Memorial Sloan-Kettering Cancer Center
- Stony Brook University Medical Center
- UNC Lineberger Comprehensive Cancer Center
- Novant Health Presbyterian Medical Center
- Park Ridge Hospital Breast Health Center
- New Hanover Regional Medical Center/Zimmer Cancer Center
- Southeast Clinical Oncology Research (SCOR) Consortium NCORP
- Summa Akron City Hospital/Cooper Cancer Center
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Hillcrest Hospital Cancer Center
- Lake University Ireland Cancer Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Abington Memorial Hospital
- Bryn Mawr Hospital
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Paoli Memorial Hospital
- Geisinger Medical Group
- Geisinger Wyoming Valley/Henry Cancer Center
- Lankenau Medical Center
- Main Line Health NCORP
- Women and Infants Hospital
- AnMed Health Cancer Center
- Saint Francis Hospital
- Gibbs Cancer Center-Pelham
- Spartanburg Medical Center
- Avera Cancer Institute
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- M D Anderson Cancer Center
- Memorial Hermann Texas Medical Center
- Scott and White Memorial Hospital
- Virginia Commonwealth University/Massey Cancer Center
- University of Wisconsin Hospital and Clinics
- Marshfield Clinic
- Aurora Saint Luke's Medical Center
- Froedtert and the Medical College of Wisconsin
- Cancer Center of Western Wisconsin
- Aurora West Allis Medical Center
- Rocky Mountain Oncology
- Welch Cancer Center
Arms of the Study
Arm 1
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.