Trial Information

The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact

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.