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

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ClinicalTrials.gov Identifier: NCT00956670
Recruitment Status : Unknown
Verified May 2017 by GOG Foundation ( Gynecologic Oncology Group ).
Recruitment status was:  Active, not recruiting
First Posted : August 11, 2009
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Tracking Information
First Submitted Date  ICMJE August 8, 2009
First Posted Date  ICMJE August 11, 2009
Last Update Posted Date May 8, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
  • 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 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2009)
  • Incidence of lymphedema
  • Quality of life as assessed by the FACT-G, FACT-Cx, FACT-V, Impact of Event Scale (IES), Lymphedema Symptoms Assessment, and Lymphadenopathy Assessment questionnaires
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • Patient self-reported symptoms [ Time Frame: Up to 24 months ]
    Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored.
  • Quality of life [ Time Frame: Up to 24 months ]
    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.
  • Risk factors for the development of lower extremity lymphoma in patients with cervical cancers [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2009)
  • Patient characteristics: age, height, weight, body mass index, performance status, race
  • Surgical characteristics: number of lymph nodes removed, laterality of nodes removed (bilateral vs. unilateral), lymph node status (presence/absence of metastases)
  • Post-surgical characteristics: development of infection, type of closed suction drain used, lymphocyst formation, use of radiation, and use of chemotherapy
  • Frequency and severity of adverse events as assessed by CTCAE v3.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Procedure: Study of High Risk Factors
    Undergo lymphedema assessment
  • Procedure: Therapeutic Conventional Surgery
    Undergo surgery
  • Procedure: Therapeutic Laparoscopic Surgery
    Undergo surgery
  • Procedure: Therapeutic Lymphadenectomy
    Undergo lymphadenectomy
Study Arms  ICMJE 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.

Interventions:
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Procedure: Study of High Risk Factors
  • Procedure: Therapeutic Conventional Surgery
  • Procedure: Therapeutic Laparoscopic Surgery
  • Procedure: Therapeutic Lymphadenectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 3, 2017)
1055
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2009)
1300
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries India
 
Administrative Information
NCT Number  ICMJE NCT00956670
Other Study ID Numbers  ICMJE GOG-0244
NCI-2011-01932 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000646813
GOG-0244 ( Other Identifier: NRG Oncology )
GOG-0244 ( Other Identifier: DCP )
GOG-0244 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
UG1CA189867 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GOG Foundation ( Gynecologic Oncology Group )
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Richard Barakat NRG Oncology
PRS Account GOG Foundation
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP