GOG-0244

The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients

Principal Investigator

Richard Barakat

Status

Disease Site

Gynecologic [GY] Other

Phase

Other

Developmental Therapeutics

No

Primary Objective

To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy for a gynecologic malignancy.

The first aim of this study is to prospectively determine the incidence of women who develop lymphedema following radical surgery for: a) uterine cancer; b) cervical cancer; or c) vulvar cancer.   

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.  
The second aim will investigate: a) patient characteristics (i.e., age, race, body mass index (BMI), vascular insufficiency, serum albumin level, performance status, medical history, and type and stage of cancer); b) surgical characteristics (i.e., site of disease, anatomic site of nodes removed, extent of nodal dissection, blood loss, operative time, open versus minimally invasive procedure, use of closed suction drainage); and c) factors within the post-surgical period (i.e., infection, lymphocyst formation, venous thromboembolic disease, nodal status, radiation therapy, chemotherapy) to identify risk factors for the development of lymphedema in gynecologic cancer survivors. This information, along with data regarding the incidence of lymphedema obtained as part of Aim 1, will be used to create a model that predicts the likelihood and degree of risk of developing lymphedema following therapy and will ultimately allow the design of strategies for prevention.

Patient Population

Patients undergoing radical surgery with a concurrent lymphadenectomy for a gynecologic malignancy.

Target Accrual

200