Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
Trial Sites
Back to Top
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Supportive care, Treatment | Approved-not yet active | 18 and over | NCI, Other | CDR0000646813 GOG-0244, NCT00956670 |
Summary
RATIONALE: 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.
PURPOSE: This clinical trial is studying lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer.
Further Study Information
OBJECTIVES:
Primary
- To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy for endometrial (uterine), cervical, or vulvar cancer.
- To identify risk factors for the development of lower extremity lymphedema following radical surgery and to develop a corresponding predictive model.
Secondary
- To identify the effect that lower extremity lymphedema has on quality of life (QOL) of these patients, as assessed by Functional Assessment of Cancer Therapy/Impact of Events Scale [FACT- IES].
- To explore if patient self-reported symptoms are associated with the development of lymphedema.
- To explore the effect of moderate or severe lymphedema on QOL outcomes, as measured by the FACT-G questionnaire.
OUTLINE: This is a multicenter study.
Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. 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. Psychosocial variables and quality of life is assessed periodically by the FACT-G, FACT-Cx, FACT-V, Impact of Event Scale (IES), Lymphedema Symptoms Assessment, and Lymphadenopathy Assessment questionnaires. Patients also complete a self-reported symptom questionnaire.
PROJECTED ACCRUAL: A total of 500 patients with endometrial cancer, 500 with cervical cancer, and 300 with vulvar cancer will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Stage I-II endometrial (uterine) carcinoma and planning to undergo hysterectomy/bilateral salpingo-oophorectomy and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic approach, including patients receiving postoperative adjuvant therapy
- Stage IA-IIA cervical carcinoma and planning to undergo radical hysterectomy or trachelectomy and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique, including patients receiving postoperative adjuvant therapy
- Stage I-IV vulvar cancer and planning to undergo definitive surgery (radical vulvectomy or radical local excision with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy and/or multimodality therapy [radiation +/- chemotherapy after undergoing surgery])
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- Serum albumin ≥ 3.0 g/dL
- No clinical history of lower extremity lymphedema
- No history of congestive heart failure, chronic renal disease, or chronic liver disease
- No history of chronic lower extremity swelling
- No history of other invasive malignancies if prior cancer treatment included any of this study's planned surgeries
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior lower extremity vascular surgery (arterial or venous) or any inguinal, hip, knee, or ankle surgery, including orthopedic procedures
- No prior pelvic, abdominal, inguinal, or lower extremity radiation therapy
- No concurrent elective surgery during the pelvic (cervical or uterine cancers) or inguinal (vulvar) lymphadenectomy
Trial Lead Organizations/Sponsors
Gynecologic Oncology Group
National Cancer Institute| Richard R. Barakat |  | Study Chair |
Trial Sites
|
|
|
|
| U.S.A. | |||
|
|||
| Arizona | |||
|
|||
| Phoenix | |||
|
|||
| St. Joseph's Hospital and Medical Center | |||
| John H Farley | Ph: 877-602-4111 | ||
| Scottsdale | |||
|
|||
| Mayo Clinic Scottsdale | |||
| Jamie N Bakkum-Gamez | Ph: 507-538-7623 | ||
| Tucson | |||
|
|||
| Arizona Cancer Center at University Medical Center North | |||
| Setsuko K Chambers | Ph: 520-626-9008 | ||
| California | |||
|
|||
| Sylmar | |||
|
|||
| Olive View - UCLA Medical Center Foundation | |||
| Christine Holschneider | Ph: 888-798-0719 | ||
| Connecticut | |||
|
|||
| Hartford | |||
|
|||
| Helen and Harry Gray Cancer Center at Hartford Hospital | |||
| James S. Hoffman | Ph: 860-224-5660 | ||
| New Britain | |||
|
|||
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | |||
| James S. Hoffman | Ph: 860-224-5660 | ||
| Delaware | |||
|
|||
| Lewes | |||
|
|||
| Tunnell Cancer Center at Beebe Medical Center | |||
| Mark E Borowsky | Ph: 302-733-6227 | ||
| Newark | |||
|
|||
| Helen F. Graham Cancer Center at Christiana Hospital | |||
| Mark E Borowsky | Ph: 302-733-6227 | ||
| Georgia | |||
|
|||
| Savannah | |||
|
|||
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | |||
| William Edward Richards | Ph: 800-622-6877 | ||
| Email: uchealthnews@uc.edu | |||
| Illinois | |||
|
|||
| Urbana | |||
|
|||
| Carle Cancer Center at Carle Foundation Hospital | |||
| Ronald E Kimball | Ph: 800-446-5532 | ||
| Indiana | |||
|
|||
| Indianapolis | |||
|
|||
| Indiana University Melvin and Bren Simon Cancer Center | |||
| Jeanne M Schilder | Ph: 317-274-2552 | ||
| St. Vincent Oncology Center | |||
| Gregory P. Sutton | Ph: 317-338-2194 | ||
| Iowa | |||
|
|||
| Des Moines | |||
|
|||
| CCOP - Iowa Oncology Research Association | |||
| Robert J Behrens | Ph: 888-244-6061 | ||
| Email: sherrijr@iora.org | |||
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |||
| Robert J Behrens | Ph: 888-244-6061 | ||
| Email: sherrijr@iora.org | |||
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |||
| Robert J Behrens | Ph: 888-244-6061 | ||
| Email: sherrijr@iora.org | |||
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |||
| Robert J Behrens | Ph: 888-244-6061 | ||
| Email: sherrijr@iora.org | |||
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |||
| Robert J Behrens | Ph: 888-244-6061 | ||
| Email: sherrijr@iora.org | |||
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |||
| Robert J Behrens | Ph: 888-244-6061 | ||
| Email: sherrijr@iora.org | |||
| Kansas | |||
|
|||
| Chanute | |||
|
|||
| Cancer Center of Kansas, PA - Chanute | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Dodge City | |||
|
|||
| Cancer Center of Kansas, PA - Dodge City | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| El Dorado | |||
|
|||
| Cancer Center of Kansas, PA - El Dorado | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Fort Scott | |||
|
|||
| Cancer Center of Kansas - Fort Scott | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Independence | |||
|
|||
| Cancer Center of Kansas-Independence | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Kingman | |||
|
|||
| Cancer Center of Kansas, PA - Kingman | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Liberal | |||
|
|||
| Cancer Center of Kansas, PA - Liberal | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Newton | |||
|
|||
| Cancer Center of Kansas, PA - Newton | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Parsons | |||
|
|||
| Cancer Center of Kansas, PA - Parsons | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Pratt | |||
|
|||
| Cancer Center of Kansas, PA - Pratt | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Salina | |||
|
|||
| Cancer Center of Kansas, PA - Salina | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Wellington | |||
|
|||
| Cancer Center of Kansas, PA - Wellington | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Wichita | |||
|
|||
| Associates in Women's Health, PA - North Hillside | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Cancer Center of Kansas, PA - Medical Arts Tower | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Cancer Center of Kansas, PA - Wichita | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| CCOP - Wichita | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Via Christi Cancer Center at Via Christi Regional Medical Center | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Winfield | |||
|
|||
| Cancer Center of Kansas, PA - Winfield | |||
| Shaker R. Dakhil | Ph: 316-262-4467 | ||
| Maryland | |||
|
|||
| Elkton MD | |||
|
|||
| Union Hospital of Cecil County | |||
| Mark E Borowsky | Ph: 302-733-6227 | ||
| Massachusetts | |||
|
|||
| Springfield | |||
|
|||
| Baystate Medical Center | |||
| Tashanna K Myers | Ph: 413-794-3565 | ||
| Email: tamara.wrenn@baystatehealth.org | |||
| Michigan | |||
|
|||
| Battle Creek | |||
|
|||
| Battle Creek Health System Cancer Care Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Big Rapids | |||
|
|||
| Mecosta County Medical Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Grand Rapids | |||
|
|||
| Butterworth Hospital at Spectrum Health | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| CCOP - Grand Rapids | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Gynecologic Oncology of West Michigan | |||
| Gordon O. Downey | Ph: 616-957-3398 | ||
| Lacks Cancer Center at Saint Mary's Health Care | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Muskegon | |||
|
|||
| Mercy General Health Partners | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Reed City | |||
|
|||
| Spectrum Health Reed City Hospital | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Traverse City | |||
|
|||
| Munson Medical Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Minnesota | |||
|
|||
| Burnsville | |||
|
|||
| Fairview Ridges Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Coon Rapids | |||
|
|||
| Mercy and Unity Cancer Center at Mercy Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Edina | |||
|
|||
| Fairview Southdale Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Fridley | |||
|
|||
| Mercy and Unity Cancer Center at Unity Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Hutchinson | |||
|
|||
| Hutchinson Area Health Care | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Maplewood | |||
|
|||
| HealthEast Cancer Care at St. John's Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Minnesota Oncology - Maplewood | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Minneapolis | |||
|
|||
| Hennepin County Medical Center - Minneapolis | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Masonic Cancer Center at University of Minnesota | |||
| Peter A Argenta | Ph: 612-624-2620 | ||
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| New Ulm | |||
|
|||
| New Ulm Medical Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Robbinsdale | |||
|
|||
| Humphrey Cancer Center at North Memorial Outpatient Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Rochester | |||
|
|||
| Mayo Clinic Cancer Center | |||
| Jamie N Bakkum-Gamez | Ph: 507-538-7623 | ||
| Saint Louis Park | |||
|
|||
| CCOP - Metro-Minnesota | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Park Nicollet Cancer Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Saint Paul | |||
|
|||
| Regions Hospital Cancer Care Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| United Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Shakopee | |||
|
|||
| St. Francis Cancer Center at St. Francis Medical Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Stillwater | |||
|
|||
| Lakeview Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Waconia | |||
|
|||
| Ridgeview Medical Center | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Willmar | |||
|
|||
| Willmar Cancer Center at Rice Memorial Hospital | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Woodbury | |||
|
|||
| Minnesota Oncology - Woodbury | |||
| Daniel M Anderson | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| Missouri | |||
|
|||
| Springfield | |||
|
|||
| Cancer Research for the Ozarks | |||
| Robert L Carolla | Ph: 417-269-4520 | ||
| Hulston Cancer Center at Cox Medical Center South | |||
| Robert L Carolla | Ph: 417-269-4520 | ||
| St. John's Regional Health Center | |||
| Robert L Carolla | Ph: 417-269-4520 | ||
| Nevada | |||
|
|||
| Las Vegas | |||
|
|||
| Women's Cancer Center - La Canada | |||
| Nick M. Spirtos | Ph: 702-851-4672 | ||
| New Mexico | |||
|
|||
| Albuquerque | |||
|
|||
| Southwest Gynecologic Oncology Associates, Incorporated | |||
| Teresa L Rutledge | Ph: 505-272-6972 | ||
| University of New Mexico Cancer Center | |||
| Teresa L Rutledge | Ph: 505-272-6972 | ||
| Las Cruces | |||
|
|||
| Memorial Medical Center | |||
| Teresa L Rutledge | Ph: 505-272-6972 | ||
| New York | |||
|
|||
| Brooklyn | |||
|
|||
| SUNY Downstate Medical Center | |||
| Ovadia Abulafia | Ph: 718-270-8216 | ||
| Email: sima.terebelo@downstate.edu | |||
| New York | |||
|
|||
| Memorial Sloan-Kettering Cancer Center | |||
| Mario M Leitao | Ph: 212-639-7202 | ||
| Stony Brook | |||
|
|||
| Stony Brook University Cancer Center | |||
| Michael L. Pearl | Ph: 800-862-2215 | ||
| North Carolina | |||
|
|||
| Chapel Hill | |||
|
|||
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |||
| Linda Van Le | Ph: 877-668-0683 | ||
| Ohio | |||
|
|||
| Akron | |||
|
|||
| Summa Center for Cancer Care at Akron City Hospital | |||
| Vivian von Gruenigen | Ph: 330-375-6101 | ||
| Cleveland | |||
|
|||
| Case Comprehensive Cancer Center | |||
| Steven E. Waggoner | Ph: 800-641-2422 | ||
| Cleveland Clinic Cancer Center at Fairview Hospital | |||
| Steven E. Waggoner | Ph: 800-641-2422 | ||
| Cleveland Clinic Taussig Cancer Center | |||
| Steven E. Waggoner | Ph: 800-641-2422 | ||
| Columbus | |||
|
|||
| Riverside Methodist Hospital Cancer Care | |||
| Jeffrey G. Bell | Ph: 614-566-4475 | ||
| Mayfield Heights | |||
|
|||
| Hillcrest Cancer Center at Hillcrest Hospital | |||
| Steven E. Waggoner | Ph: 800-641-2422 | ||
| Mentor | |||
|
|||
| Lake/University Ireland Cancer Center | |||
| Steven E. Waggoner | Ph: 800-641-2422 | ||
| Oklahoma | |||
|
|||
| Oklahoma City | |||
|
|||
| Oklahoma University Cancer Institute | |||
| Robert S. Mannel | Ph: 405-271-4272 | ||
| Email: julie-traylor@ouhsc.edu | |||
| Tulsa | |||
|
|||
| Cancer Care Associates-Yale | |||
| Robert S. Mannel | Ph: 405-271-4272 | ||
| Email: julie-traylor@ouhsc.edu | |||
| Pennsylvania | |||
|
|||
| Abington | |||
|
|||
| Rosenfeld Cancer Center at Abington Memorial Hospital | |||
| Parviz Hanjani | Ph: 215-481-2402 | ||
| Rhode Island | |||
|
|||
| Providence | |||
|
|||
| Women and Infants Hospital of Rhode Island | |||
| Paul A. DiSilvestro | Ph: 401-274-1122 | ||
| South Carolina | |||
|
|||
| Anderson | |||
|
|||
| AnMed Cancer Center | |||
| David Griffin | Ph: 864-512-1000 | ||
| Greenville | |||
|
|||
| Bon Secours St. Francis Health System | |||
| David Griffin | Ph: 864-512-1000 | ||
| Spartanburg | |||
|
|||
| CCOP - Upstate Carolina | |||
| David Griffin | Ph: 864-512-1000 | ||
| South Dakota | |||
|
|||
| Sioux Falls | |||
|
|||
| Avera Cancer Institute | |||
| Luis A Rojas-Espaillat | Ph: 800-657-4377 | ||
| Email: Jan.Healy@avera.org | |||
| Texas | |||
|
|||
| Dallas | |||
|
|||
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |||
| David Scott Miller | Ph: 214-648-7097 | ||
| Houston | |||
|
|||
| Univeristy of Texas M.D. Anderson Cancer Center | |||
| Diane C. Bodurka | Ph: 713-792-3245 | ||
| Temple | |||
|
|||
| Scott and White Cancer Institute | |||
| Charles V. Capen | Ph: 254-724-5407 | ||
| Virginia | |||
|
|||
| Richmond | |||
|
|||
| Virginia Commonwealth University Massey Cancer Center | |||
| Weldon E Chafe | Ph: 804-628-1939 | ||
| Wisconsin | |||
|
|||
| Marshfield | |||
|
|||
| Marshfield Clinic - Marshfield Center | |||
| Anthony C. Evans | Ph: 715-389-4457 | ||
| Milwaukee | |||
|
|||
| Froedtert Hospital and Medical College of Wisconsin | |||
| William H Bradley | Ph: 414-805-4380 | ||
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | |||
| Scott A Kamelle | Ph: 414-649-7200 | ||
| New Richmond | |||
|
|||
| Cancer Center of Western Wisconsin | |||
| Joseph W Leach | Ph: 952-993-1517 | ||
| Email: MMCCOP@parknicollet.com | |||
| West Allis | |||
|
|||
| Aurora Women's Pavilion of West Allis Memorial Hospital | |||
| Peter Johnson | Ph: 800-252-2990 | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00956670
Information obtained from ClinicalTrials.gov on April 04, 2013
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
Back to Top
