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LymphedemaLEGNCT00956670

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

A study testing Quality-of-Life Assessment, Questionnaire Administration and Study of High Risk Factors in people with Lymphedema and Stage IA Cervical Cancer, run by Gynecologic Oncology Group at 213 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Quality-of-Life Assessment, Questionnaire Administration and Study of High Risk Factors
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,055 participants
Where
213 sitesUnited States
Study dates
Jun 2012to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

213 sites in 1 country.

213 sites in 1 country

United States213 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Southwest Gynecologic Oncology Associates Inc

    Albuquerque, New Mexico, 87106

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Hematology/Oncology Clinic LLP

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Mills - Peninsula Hospitals

    Burlingame, California, 94010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Sutter Davis Hospital

    Davis, California, 95616

  • Beaumont Hospital-Dearborn

    Dearborn, Michigan, 48124

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Park Ridge Hospital Breast Health Center

    Hendersonville, North Carolina, 28792

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Allegiance Health

    Jackson, Michigan, 49201

  • Saint Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Memorial Medical Center - Las Cruces

    Las Cruces, New Mexico, 88011

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Memorial Medical Center

    Modesto, California, 95355

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

  • Palo Alto Medical Foundation-Gynecologic Oncology

    Mountain View, California, 94040

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Christiana Gynecologic Oncology LLC

    Newark, Delaware, 19713

  • Delaware Clinical and Laboratory Physicians PA

    Newark, Delaware, 19713

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Regional Hematology and Oncology PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Lakeland Community Hospital

    Niles, Michigan, 49120

  • Sutter Cancer Research Consortium

    Novato, California, 94945

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Gynecologic Oncology Group of Arizona

    Phoenix, Arizona, 85012

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Maine Medical Center-Bramhall Campus

    Portland, Maine, 04102

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Saint John's Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Sutter General Hospital

    Sacramento, California, 95816

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94115

  • Palo Alto Medical Foundation-Santa Cruz

    Santa Cruz, California, 95065

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

  • Memorial University Medical Center

    Savannah, Georgia, 31404

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Maine Medical Center- Scarborough Campus

    Scarborough, Maine, 04074

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Palo Alto Medical Foundation-Sunnyvale

    Sunnyvale, California, 94086

  • Olive View-University of California Los Angeles Medical Center

    Sylmar, California, 91342

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48098

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Sutter Cancer Centers Radiation Oncology Services-Vacaville

    Vacaville, California, 95687

  • Sutter Solano Medical Center/Cancer Center

    Vallejo, California, 94589

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

  • New Hanover Regional Medical Center/Zimmer Cancer Center

    Wilmington, North Carolina, 28401

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Southeast Clinical Oncology Research (SCOR) Consortium NCORP

    Winston-Salem, North Carolina, 27104

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Main Line Health NCORP

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Quality-of-Life Assessment, Questionnaire Administration, Study of High Risk Factors, Therapeutic Conventional Surgery, Therapeutic Laparoscopic Surgery
Medical subject headings
Lymphedema, Uterine Cervical Neoplasms, Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Study of High Risk FactorsProcedure or surgery

    Undergo lymphedema assessment

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgery

  • Therapeutic Laparoscopic SurgeryProcedure or surgery

    Undergo surgery

  • Therapeutic LymphadenectomyProcedure or surgery

    Undergo lymphadenectomy

Study groups in NCT00956670
Study groupRoleWhat they receive
Supportive care (lymphedema assessment)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Up to 24 months

  2. Risk factors for the development of lower extremity lymphoma in patients with endometrial cancers

    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.

    Measured: Up to 24 months

Secondary outcomes (3)

  1. Patient self-reported symptoms

    Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored.

    Measured: Up to 24 months

  2. Quality of life

    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.

    Measured: Up to 24 months

  3. Risk factors for the development of lower extremity lymphoma in patients with cervical cancers

    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.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2009 (estimated)
  2. Study startJun 2012
  3. Primary completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,055 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00956670
Sponsor's protocol ID
GOG-0244
Other IDs
NCI-2011-01932, CDR0000646813, GOG-0244, GOG-0244, GOG-0244, U10CA101165, UG1CA189867
Acronym
LEG
Status last verified
May 2017
First submitted
8 Aug 2009
Last updated
8 May 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Quality-of-Life Assessment, Questionnaire Administration and Study of High Risk Factors in people with Lymphedema and Stage IA Cervical Cancer, run by Gynecologic Oncology Group at 213 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 213 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00956670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.

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