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

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Brief Title

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

Official Title

The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients

Brief Summary

      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.
    

Detailed Description

      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).

      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. (Closed to
      accrual as of June 9, 2014)

      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.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Patient self-reported symptoms

Condition

Lymphedema

Intervention

Quality-of-Life Assessment

Study Arms / Comparison Groups

 Supportive care (lymphedema assessment)
Description:  Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

1055

Start Date

June 2012


Primary Completion Date

April 2015

Eligibility Criteria

        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; (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

        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

          -  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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Richard Barakat, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00956670

Organization ID

GOG-0244

Secondary IDs

NCI-2011-01932

Responsible Party

Sponsor

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Richard Barakat, Principal Investigator, NRG Oncology


Verification Date

May 2017