The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 1,055
- 试验地点
- 424
- 主要终点
- Incidence of lymphedema, assessed through volumetric measurements using serial circumferential measurements performed from 10 cm above the heel to the inguinal crease at 10 cm intervals
研究概览
简要总结
This clinical trial studies lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer. Collecting information over time about how often lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer, cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the best treatment.
详细描述
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 among patients with any one of the three types of gynecologic malignancy studied 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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; (note: enrollment of vulvar patients was closed on June 9, 2014; no vulvar patients will be enrolled after closure of this arm)
- •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
排除标准
- •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
- •Vulvar patients, from June 9, 2014 on
- •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
结局指标
主要结局
Incidence of lymphedema, assessed through volumetric measurements using serial circumferential measurements performed from 10 cm above the heel to the inguinal crease at 10 cm intervals
时间窗: Up to 24 months
A competing risks analysis will be required to estimate the cumulative incidence of lymphedema. Transition probabilities in the Markov Chain will be estimated by simple proportions, ignoring covariates, to address this primary objective. Confidence intervals for the cumulative incidence of lymphedema then will be computed using the Delta Method, utilizing the fact that the transition proportions have and asymptotic multivariate normal distribution.
Risk factors for the development of lower extremity lymphoma in patients with endometrial cancers
时间窗: Up to 24 months
If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically. The predictive power of the models for these rates will be assessed.
次要结局
- Patient self-reported symptoms(Up to 24 months)
- Risk factors for the development of lower extremity lymphoma in patients with cervical cancers(Up to 24 months)
- Quality of life(Up to 24 months)