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

18 Years
Not Enrolling
Cervical Cancer, Endometrial Cancer, Lymphedema, Vulvar Cancer

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Trial Information

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



- 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.


- 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

- 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

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.

Inclusion Criteria


- 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

- 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])


- 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

- 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


- 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

Type of Study:


Study Design:

Primary Purpose: Supportive Care

Outcome Measure:

Incidence of lymphedema

Safety Issue:


Principal Investigator

Richard R. Barakat, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center



Study ID:




Start Date:

October 2009

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Lymphedema
  • Vulvar Cancer
  • lymphedema
  • stage IA cervical cancer
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • stage I vulvar cancer
  • stage II vulvar cancer
  • stage III vulvar cancer
  • stage IV vulvar cancer
  • stage IA endometrial carcinoma
  • stage IB endometrial carcinoma
  • stage II endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Uterine Cervical Neoplasms
  • Lymphedema
  • Vulvar Neoplasms
  • Adenoma