Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00956670
Other study ID # GOG-0244
Secondary ID NCI-2011-01932CD
Status Active, not recruiting
Phase N/A
First received August 8, 2009
Last updated May 3, 2017
Start date June 2012

Study information

Verified date May 2017
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 learn more about the disease and plan the best treatment.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1055
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Abington Memorial Hospital Abington Pennsylvania
United States Summa Akron City Hospital/Cooper Cancer Center Akron Ohio
United States Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States AnMed Health Cancer Center Anderson South Carolina
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University/Winship Cancer Institute Atlanta Georgia
United States Sutter Auburn Faith Hospital Auburn California
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States Augusta University Medical Center Augusta Georgia
United States University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora Colorado
United States Hematology/Oncology Clinic LLP Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Bozeman Deaconess Hospital Bozeman Montana
United States State University of New York Downstate Medical Center Brooklyn New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Mills - Peninsula Hospitals Burlingame California
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Rocky Mountain Oncology Casper Wyoming
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States John B Amos Cancer Center Columbus Georgia
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle on Vermilion Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Sutter Davis Hospital Davis California
United States Beaumont Hospital-Dearborn Dearborn Michigan
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Saint John Hospital and Medical Center Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States City of Hope Comprehensive Cancer Center Duarte California
United States Fairview-Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Union Hospital of Cecil County Elkton Maryland
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Unity Hospital Fridley Minnesota
United States Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Saint Francis Hospital Greenville South Carolina
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Hartford Hospital Hartford Connecticut
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Park Ridge Hospital Breast Health Center Hendersonville North Carolina
United States M D Anderson Cancer Center Houston Texas
United States Memorial Hermann Texas Medical Center Houston Texas
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Saint Vincent Hospital and Health Care Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Allegiance Health Jackson Michigan
United States Saint Dominic-Jackson Memorial Hospital Jackson Mississippi
United States Kalispell Regional Medical Center Kalispell Montana
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Sparrow Hospital Lansing Michigan
United States Memorial Medical Center - Las Cruces Las Cruces New Mexico
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Beebe Medical Center Lewes Delaware
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Mary Mercy Hospital Livonia Michigan
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marshfield Clinic Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Lake University Ireland Cancer Center Mentor Ohio
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Memorial Medical Center Modesto California
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States Mercy Health Mercy Campus Muskegon Michigan
United States The Hospital of Central Connecticut New Britain Connecticut
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Christiana Gynecologic Oncology LLC Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Regional Hematology and Oncology PA Newark Delaware
United States Cancer Center of Kansas - Newton Newton Kansas
United States Lakeland Community Hospital Niles Michigan
United States Sutter Cancer Research Consortium Novato California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Gynecologic Oncology Group of Arizona Phoenix Arizona
United States Mayo Clinic Hospital Phoenix Arizona
United States Saint Joseph's Hospital and Medical Center Phoenix Arizona
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Maine Medical Center-Bramhall Campus Portland Maine
United States Kootenai Cancer Center Post Falls Idaho
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Women and Infants Hospital Providence Rhode Island
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic Rochester Minnesota
United States Saint John's Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Sutter General Hospital Sacramento California
United States Saint Mary's of Michigan Saginaw Michigan
United States Lakeland Hospital Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas - Salina Salina Kansas
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Sutter Pacific Medical Foundation Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Memorial University Medical Center Savannah Georgia
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Welch Cancer Center Sheridan Wyoming
United States Avera Cancer Institute Sioux Falls South Dakota
United States Spartanburg Medical Center Spartanburg South Carolina
United States Baystate Medical Center Springfield Massachusetts
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Geisinger Medical Group State College Pennsylvania
United States Lakeview Hospital Stillwater Minnesota
United States Stony Brook University Medical Center Stony Brook New York
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Olive View-University of California Los Angeles Medical Center Sylmar California
United States Scott and White Memorial Hospital Temple Texas
United States Munson Medical Center Traverse City Michigan
United States William Beaumont Hospital - Troy Troy Michigan
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States Ridgeview Medical Center Waconia Minnesota
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Via Christi Regional Medical Center Wichita Kansas
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Southeast Clinical Oncology Research (SCOR) Consortium NCORP Winston-Salem North Carolina
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Main Line Health NCORP Wynnewood Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 24 months
Primary 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. Up to 24 months
Secondary Patient self-reported symptoms Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored. Up to 24 months
Secondary 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. Up to 24 months
Secondary 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. Up to 24 months
See also
  Status Clinical Trial Phase
Completed NCT05507346 - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema N/A
Completed NCT06067880 - Surgical Intervention and Lymphatic Diseases.
Active, not recruiting NCT04797390 - A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema N/A
Completed NCT02676752 - Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Completed NCT06323200 - Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
Completed NCT02506530 - Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema N/A
Terminated NCT02020837 - A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema Early Phase 1
Completed NCT02253186 - Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema N/A
Recruiting NCT01318785 - Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications Phase 2
Enrolling by invitation NCT02375165 - Biomarkers for the Detection of Lymphatic Insufficiency
Completed NCT01112189 - Use of Stem Cells in Lymphedema Post Mastectomy Phase 1/Phase 2
Completed NCT02308488 - Study of Prone Accelerated Breast And Nodal IMRT N/A
Completed NCT00852930 - Low Level Laser Treatment and Breast Cancer Related Lymphedema Phase 4
Completed NCT00743314 - Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer Early Phase 1
Recruiting NCT06237907 - Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
Terminated NCT01580800 - National Breast Cancer and Lymphedema Registry
Suspended NCT05366699 - LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy N/A
Completed NCT06249360 - Lymphatic System Reflux After Lymphatic Operation
Completed NCT06220903 - The Effect of Complex Decongestive Therapy in Patients With Lymphedema N/A
Terminated NCT02923037 - Hatha Yoga in Breast Cancer Survivors N/A