Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer

PRIMARY OBJECTIVES:

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

II. To identify risk factors for the development of lower extremity lymphedema following
radical surgery for each of three types of gynecologic malignancy and to develop a
corresponding predictive model.

SECONDARY OBJECTIVES:

I. To identify the effect that lower extremity lymphedema has on quality of life (QOL) (as
measured with Functional Assessment of Cancer Therapy - General [FACT-G] + disease specific
subscale), psychological adjustment (as measured with Impact of Events Scale [IES] and
Functional Assessment of Chronic Illness Therapy [FACIT] body image items) and physical
disability (of lower extremity as measured with Lower Extremity Functional Scale [LEFS]) and
physical function(as measured by FACT-Functional Wellbeing [FW] subscale, FACIT disease
specific items & patient-reported outcomes measurement information system [PROMIS] items)
and to investigate potential protective mechanisms (FACT-Social Wellbeing [SW] subscale and
patient characteristics).

II. To explore if patient self-reported symptoms (as measured with the lymphedema [LE]
Symptom Measure [Cancer Lymphedema Questionnaire (GCLQ)]) are associated with the
development of lymphedema in patients undergoing radical surgery for gynecologic malignancy.

TERTIARY OBJECTIVES:

I. To explore the effect of moderate or severe lymphedema (primary endpoint) on QOL
outcomes, as measured by the FACT-General (G) questionnaire.

OUTLINE:

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.

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

- 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

- 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