Lymphedema Clinical Trial
— LEGOfficial title:
The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients
Verified date | May 2017 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 1055 |
Est. completion date | |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio |
United States | Southwest Gynecologic Oncology Associates Inc | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | AnMed Health Cancer Center | Anderson | South Carolina |
United States | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Emory University Hospital Midtown | Atlanta | Georgia |
United States | Emory University/Winship Cancer Institute | Atlanta | Georgia |
United States | Sutter Auburn Faith Hospital | Auburn | California |
United States | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California |
United States | Augusta University Medical Center | Augusta | Georgia |
United States | University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado |
United States | Hematology/Oncology Clinic LLP | Baton Rouge | Louisiana |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California |
United States | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Montana Cancer Consortium NCORP | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | State University of New York Downstate Medical Center | Brooklyn | New York |
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Mills - Peninsula Hospitals | Burlingame | California |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
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 | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center-West Lakes | Clive | Iowa |
United States | John B Amos Cancer Center | Columbus | Georgia |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Parkland Memorial Hospital | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Carle on Vermilion | Danville | Illinois |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Sutter Davis Hospital | Davis | California |
United States | Beaumont Hospital-Dearborn | Dearborn | Michigan |
United States | Iowa Lutheran Hospital | Des Moines | 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 | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Cancer Center of Kansas - Dodge City | Dodge City | Kansas |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Fairview-Southdale Hospital | Edina | Minnesota |
United States | Carle Physician Group-Effingham | Effingham | Illinois |
United States | Cancer Center of Kansas - El Dorado | El Dorado | Kansas |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Unity Hospital | Fridley | Minnesota |
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 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Saint Francis Hospital | Greenville | South Carolina |
United States | Gibbs Cancer Center-Pelham | Greer | South Carolina |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut |
United States | Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Park Ridge Hospital Breast Health Center | Hendersonville | North Carolina |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Memorial Hermann Texas Medical Center | Houston | Texas |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
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 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | Allegiance Health | Jackson | Michigan |
United States | Saint Dominic-Jackson Memorial Hospital | Jackson | Mississippi |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Cancer Center of Kansas-Kingman | Kingman | Kansas |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Memorial Medical Center - Las Cruces | Las Cruces | New Mexico |
United States | Women's Cancer Center of Nevada | Las Vegas | Nevada |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Cancer Center of Kansas-Liberal | Liberal | Kansas |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
United States | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | Cancer Center of Kansas-Manhattan | Manhattan | Kansas |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois |
United States | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio |
United States | Cancer Center of Kansas - McPherson | McPherson | Kansas |
United States | Lake University Ireland Cancer Center | Mentor | Ohio |
United States | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin |
United States | Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Health Partners Inc | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
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 | Mercy Health Mercy Campus | Muskegon | Michigan |
United States | The Hospital of Central Connecticut | New Britain | Connecticut |
United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | New Ulm Medical Center | New Ulm | Minnesota |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Christiana Care Health System-Christiana Hospital | Newark | 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 | Cancer Center of Kansas - Newton | Newton | Kansas |
United States | Lakeland Community Hospital | Niles | Michigan |
United States | Sutter Cancer Research Consortium | Novato | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Palo Alto Medical Foundation Health Care | Palo Alto | California |
United States | Paoli Memorial Hospital | Paoli | Pennsylvania |
United States | Cancer Center of Kansas - Parsons | Parsons | Kansas |
United States | Gynecologic Oncology Group of Arizona | Phoenix | Arizona |
United States | Mayo Clinic Hospital | Phoenix | Arizona |
United States | Saint Joseph's Hospital and Medical Center | Phoenix | Arizona |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Lake Huron Medical Center | Port Huron | Michigan |
United States | Maine Medical Center-Bramhall Campus | Portland | Maine |
United States | Kootenai Cancer Center | Post Falls | Idaho |
United States | Cancer Center of Kansas - Pratt | Pratt | Kansas |
United States | Women and Infants Hospital | Providence | Rhode Island |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Beebe Health Campus | Rehoboth Beach | Delaware |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Saint John's Clinic-Rolla-Cancer and Hematology | Rolla | Missouri |
United States | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California |
United States | Sutter Roseville Medical Center | Roseville | California |
United States | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan |
United States | Sutter General Hospital | Sacramento | California |
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 | Mercy Hospital Saint Louis | Saint Louis | Missouri |
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 | Cancer Center of Kansas - Salina | Salina | Kansas |
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 | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia |
United States | Memorial University Medical Center | Savannah | Georgia |
United States | Maine Medical Center- Scarborough Campus | Scarborough | Maine |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | Cancer Research for the Ozarks NCORP | Springfield | Missouri |
United States | CoxHealth South Hospital | Springfield | Missouri |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | Geisinger Medical Group | State College | Pennsylvania |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California |
United States | Olive View-University of California Los Angeles Medical Center | Sylmar | California |
United States | Scott and White Memorial Hospital | Temple | Texas |
United States | Munson Medical Center | Traverse City | Michigan |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | University of Arizona Cancer Center-North Campus | Tucson | Arizona |
United States | Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma |
United States | Carle Cancer Center | Urbana | Illinois |
United States | The Carle Foundation Hospital | Urbana | Illinois |
United States | Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California |
United States | Sutter Solano Medical Center/Cancer Center | Vallejo | California |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
United States | Aurora West Allis Medical Center | West Allis | Wisconsin |
United States | Mercy Medical Center-West Lakes | West Des Moines | Iowa |
United States | Methodist West Hospital | West Des Moines | Iowa |
United States | Associates In Womens Health | Wichita | Kansas |
United States | Cancer Center of Kansas - Wichita | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wichita NCI Community Oncology Research Program | Wichita | Kansas |
United States | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware |
United States | New Hanover Regional Medical Center/Zimmer Cancer Center | Wilmington | North Carolina |
United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
United States | Southeast Clinical Oncology Research (SCOR) Consortium NCORP | Winston-Salem | North Carolina |
United States | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
United States | Main Line Health NCORP | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Up to 24 months | |
Primary | Risk factors for the development of lower extremity lymphoma in patients with endometrial cancers | 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. | Up to 24 months | |
Secondary | Patient self-reported symptoms | Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored. | Up to 24 months | |
Secondary | Quality of life | 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. | Up to 24 months | |
Secondary | Risk factors for the development of lower extremity lymphoma in patients with cervical cancers | 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. | Up to 24 months |
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