GOG 0244: The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors and Impact in Newly Diagnosed Patients
This is a prospective longitudinal study evaluating the incidence and impact of lymphedema following radical surgery for gynecologic malignancy. The relationship of the lymphadenectomy on the lower extremity will be assessed through volumetric measurements using serial circumferential measurements performed from 10 cm above the heel to the inguinal crease at 10 cm intervals.
These measurements will be performed preoperatively, 4-6 weeks postoperatively, approximately every 3 months for the first year (3, 6, 9, and 12 months) and then approximately every 6 months (18, 24 months) until the patient is 24 months post-op to capture those patients with late onset (after 12 months) development of lymphedema. Data will be collected regarding known, suspected, and possible risk factors for the development of lymphedema. These data will include age; race; BMI; vascular insufficiency; serum albumin level; cancer type and stage; performance status; medical history; the number and type of lymph nodes removed; laterality of nodes removed (unilateral vs. bilateral); blood loss; operative time; use of closed suction drainage and duration of use; laparotomy vs. minimally invasive surgery; lymph node status (metastases); perioperative infection; lymphocyst formation; deep vein thrombosis; use and dose of radiation; thromboembolic prophylaxis while in the hospital and after discharge and use of chemotherapy.
In addition, patients will complete a questionnaire that will assess their subjective symptom experience as to the presence of lymphedema to determine if this is correlated with the objective measurements of lower limb and to determine the extent to which these subjective impressions correlate with formal QOL measurement. The LE Symptom Measure (GCLQ), disability assessment of the lower extremity functional scale (LEFS), limb measurements, QOL measurements (FACT), psychological adjustment (IES/ FACIT body image items) and patient reported [PROs] functional health status (FACT-FW, FACIT disease specific items/ PROMIS) will be performed preoperatively.
Limb measurements, gynecologic cancer lymphedema questionnaire (GCLQ), and disability (LEFS) will be completed 4 to 6 weeks postoperatively and then approximately every 3 months for the first year (3, 6, 9, and 12 months) and then approximately every 6 months (18, 24 months) until the patient is 24 months post-op. In order to minimize patient burden and missing data, the QOL measurements (FACT), psychological adjustment (IES/ FACIT body image items) and patient reported [PROs] functional health status (FACT-FW, FACIT disease specific items/ PROMIS) will be administered every 6 months (6, 12, 18, 24 months) until the patient is 24 months post-op.
3.11 Patients will be registered into three distinct groupings, and each group will be analyzed as a separate study:
3.111 Patients who will undergo hysterectomy/BSO and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique for clinical stage I-II uterine carcinoma, including those receiving postoperative adjuvant therapy. Patients enrolling after surgery may have a pathologic stage of I-III.
3.112 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.
3.113 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.
3.12 Patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy.
3.13 Patients must have signed an approved informed consent and authorization permitting release of personal health information, and >= 18 years of age.
3.14 Patients must have a Serum Albumin level of >=3.0 within 14 days of entry.
3.15 Surgery must occur within 5 business days before study entry or within eight weeks after study entry. (07/15/13)