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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00956670
First received: August 8, 2009
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Lymphedema
Stage IA Cervical Cancer
Stage IA Uterine Corpus Cancer
Stage IA Vulvar Cancer
Stage IB Cervical Cancer
Stage IB Uterine Corpus Cancer
Stage IB Vulvar Cancer
Stage II Uterine Corpus Cancer
Stage II Vulvar Cancer
Stage IIA Cervical Cancer
Stage IIIA Vulvar Cancer
Stage IIIB Vulvar Cancer
Stage IIIC Vulvar Cancer
Stage IVB Vulvar Cancer
Procedure: Therapeutic Lymphadenectomy
Procedure: Therapeutic Conventional Surgery
Procedure: Therapeutic Laparoscopic Surgery
Procedure: Study of High Risk Factors
Other: Questionnaire Administration
Other: Quality-of-Life Assessment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Risk factors for the development of lower extremity lymphoma in patients with cervical cancers [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Quality of life [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    As measured by the FACT QOL scale, psychological adjustment as measured by the Impact of Events Subscale (IES), and FACIT body image items, physical disability as measured by the Lower Extremity Functional Scale -(LEFS) and PROs of physical health status/function (sexual), as measured by FACT-FW; FACIT & PROMIS.

  • Patient self-reported symptoms [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored.


Estimated Enrollment: 1037
Study Start Date: June 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (lymphedema assessment)

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.

Procedure: Therapeutic Lymphadenectomy
Undergo lymphadenectomy
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Procedure: Therapeutic Laparoscopic Surgery
Undergo surgery
Procedure: Study of High Risk Factors
Undergo lymphedema assessment
Other: Questionnaire Administration
Ancillary studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956670

  Show 214 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Richard Barakat NRG Oncology
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00956670     History of Changes
Other Study ID Numbers: GOG-0244, NCI-2011-01932, CDR0000646813, GOG-0244, GOG-0244, GOG-0244, U10CA101165, UG1CA189867
Study First Received: August 8, 2009
Last Updated: December 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphedema
Uterine Cervical Neoplasms
Uterine Neoplasms
Vulvar Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on July 26, 2015