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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00956670
First received: August 8, 2009
Last updated: March 7, 2014
Last verified: March 2014

August 8, 2009
March 7, 2014
June 2012
July 2017   (final data collection date for primary outcome measure)
  • 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.
  • Surgical outcome including number of lymph nodes removed, laterality of nodes removed (bilateral vs. unilateral), lymph node status (presence/absence of metastases) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Post-surgical outcome including development of infection, type of closed suction drain used, lymphocyst formation, use of radiation, and use of chemotherapy [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the FACT-G, FACT-Cx, FACT-V, IES, Lymphedema Symptoms Assessment, and Lymphadenopathy Assessment questionnaires [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    A mixed linear model similar to above one will be fitted to the FACT-G scores with the moderate or severe lymphedema as a time-dependent variable.
  • Self-report of lymphedema symptoms as measured by the Lymphedema Scale which assesses 20 symptoms [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    The lower lymphedema symptoms will be assessed with the GCLQ. A generalized linear mixed model will be used to explore the relationship in changes in limb volume. To reflect the observed covariance pattern of the QOL data, the 'empirical' variance will be used in estimating the precision of parameter estimates. Satterthwaite's DF will be used in significance testing.
  • 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 [ Designated as safety issue: No ]
  • Incidence of lymphedema [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00956670 on ClinicalTrials.gov Archive Site
Not Provided
  • Patient characteristics: age, height, weight, body mass index, performance status, race [ Designated as safety issue: No ]
  • Surgical characteristics: number of lymph nodes removed, laterality of nodes removed (bilateral vs. unilateral), lymph node status (presence/absence of metastases) [ Designated as safety issue: No ]
  • Post-surgical characteristics: development of infection, type of closed suction drain used, lymphocyst formation, use of radiation, and use of chemotherapy [ Designated as safety issue: No ]
  • Frequency and severity of adverse events as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients

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.

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 for each of three types of gynecologic malignancy 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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Lymphedema
  • Stage IA Cervical Cancer
  • Stage IA Endometrial Carcinoma
  • Stage IA Vulvar Cancer
  • Stage IB Cervical Cancer
  • Stage IB Endometrial Carcinoma
  • Stage IB Vulvar Cancer
  • Stage II Endometrial Carcinoma
  • 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
    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
  • Procedure: psychosocial assessment and care
    Ancillary studies
    Other Names:
    • psychosocial assessment
    • psychosocial assessment/care
    • psychosocial care
    • psychosocial care/assessment
    • psychosocial studies
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
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.

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:
  • Procedure: therapeutic lymphadenectomy
  • Procedure: therapeutic conventional surgery
  • Procedure: therapeutic laparoscopic surgery
  • Procedure: study of high risk factors
  • Other: questionnaire administration
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1300
Not Provided
July 2017   (final data collection date for primary outcome measure)

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
  • 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
  • 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
Female
18 Years and older
No
United States,   India
 
NCT00956670
GOG-0244, NCI-2011-01932, CDR0000646813, GOG-0244, GOG-0244, GOG-0244, U10CA101165
Yes
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Richard Barakat Gynecologic Oncology Group
Gynecologic Oncology Group
March 2014

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