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
  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 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
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

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.

  • 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.


Estimated Enrollment: 1300
Study Start Date: June 2012
Estimated Primary Completion Date: July 2017 (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.

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
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

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 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.

  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
  • 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
  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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Warner K. Huh    205-934-0309      
Principal Investigator: Warner K. Huh         
United States, Arizona
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: John H. Farley    877-602-4111      
Principal Investigator: John H. Farley         
Gynecologic Oncology Group of Arizona Active, not recruiting
Phoenix, Arizona, United States, 85012
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Jamie N. Bakkum-Gamez    507-538-7623      
Principal Investigator: Jamie N. Bakkum-Gamez         
Arizona Cancer Center at University Medical Center North Recruiting
Tucson, Arizona, United States, 85719
Contact: Setsuko K. Chambers    520-626-9008      
Principal Investigator: Setsuko K. Chambers         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Alexander F. Burnett    501-686-8274      
Principal Investigator: Alexander F. Burnett         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Thanh H. Dellinger    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Thanh H. Dellinger         
Kaiser Permanente Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact: Scott E. Lentz    626-564-3455      
Principal Investigator: Scott E. Lentz         
University of California at Los Angeles (UCLA ) Recruiting
Los Angeles, California, United States, 90095
Contact: Robin Farias-Eisner    888-798-0719      
Principal Investigator: Robin Farias-Eisner         
Olive View-University of California Los Angeles Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Christine H. Holschneider    888-798-0719      
Principal Investigator: Christine H. Holschneider         
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Susan A. Davidson    720-848-0650      
Principal Investigator: Susan A. Davidson         
United States, Connecticut
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
United States, Delaware
Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Mark E. Borowsky    302-733-6227      
Principal Investigator: Mark E. Borowsky         
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Mark E. Borowsky    302-733-6227      
Principal Investigator: Mark E. Borowsky         
United States, Georgia
Emory University/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Namita Khanna    404-778-1868      
Principal Investigator: Namita Khanna         
John B Amos Cancer Center Recruiting
Columbus, Georgia, United States, 31904
Contact: Gregory P. Sfakianos    706-660-6404      
Principal Investigator: Gregory P. Sfakianos         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403
Contact: James J. Burke    912-350-8568      
Principal Investigator: James J. Burke         
Saint Joseph's-Candler Health System Recruiting
Savannah, Georgia, United States, 31405
Contact: William E. Richards    800-622-6877    uchealthnews@uc.edu   
Principal Investigator: William E. Richards         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
United States, Illinois
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Ronald E. Kimball    800-446-5532      
Principal Investigator: Ronald E. Kimball         
United States, Indiana
Indiana University Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jeanne M. Schilder    317-274-2552      
Principal Investigator: Jeanne M. Schilder         
Saint Vincent Oncology Center Terminated
Indianapolis, Indiana, United States, 46260
United States, Iowa
Mercy Cancer Center-West Lakes Recruiting
Clive, Iowa, United States, 50325
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Iowa Oncology Research Association CCOP Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Laurel Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Des Moines Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Methodist West Hospital Recruiting
West Des Moines, Iowa, United States, 50266-7700
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Mercy Medical Center-West Lakes Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
United States, Kansas
Cancer Center of Kansas - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Manhattan Recruiting
Manhattan, Kansas, United States, 66502
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Main Office Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Wichita Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Wichita CCOP Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Associates In Womens Health Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
United States, Louisiana
Hematology/Oncology Clinic LLP Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: William R. Robinson    504-988-6121      
Principal Investigator: William R. Robinson         
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: William R. Robinson    504-988-6121      
Principal Investigator: William R. Robinson         
United States, Maine
Maine Medical Center-Bramhall Campus Recruiting
Portland, Maine, United States, 04102
Contact: Christopher J. Darus    207-885-7565      
Principal Investigator: Christopher J. Darus         
United States, Maryland
Union Hospital of Cecil County Terminated
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Tashanna K. Myers    413-794-3565    tamara.wrenn@baystatehealth.org   
Principal Investigator: Tashanna K. Myers         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Michigan Cancer Research Consortium Community Clinical Oncology Program Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Spectrum Health Big Rapids Hospital Recruiting
Big Rapids, Michigan, United States, 49307
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Oakwood Hospital Recruiting
Dearborn, Michigan, United States, 48124
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48502
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Gynecologic Oncology of West Michigan PLLC Active, not recruiting
Grand Rapids, Michigan, United States, 49546
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Grand Rapids Clinical Oncology Program Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Mercy Health Mercy Campus Recruiting
Muskegon, Michigan, United States, 49444
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Joseph Mercy Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Spectrum Health Reed City Hospital Recruiting
Reed City, Michigan, United States, 49677
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
William Beaumont Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Jayson B. Field    248-551-7695      
Principal Investigator: Jayson B. Field         
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
William Beaumont Hospital - Troy Recruiting
Troy, Michigan, United States, 48098
Contact: Jayson B. Field    248-551-7695      
Principal Investigator: Jayson B. Field         
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
University of Minnesota Medical Center-Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Peter A. Argenta    612-624-2620      
Principal Investigator: Peter A. Argenta         
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jamie N. Bakkum-Gamez    507-538-7623      
Principal Investigator: Jamie N. Bakkum-Gamez         
Metro-Minnesota CCOP Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
Minnesota Oncology and Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Daniel M. Anderson    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Daniel M. Anderson         
United States, Mississippi
Saint Dominic-Jackson Memorial Hospital Recruiting
Jackson, Mississippi, United States, 39216
Contact: Donald P. Seago    601-200-3300      
Principal Investigator: Donald P. Seago         
United States, Missouri
Saint John's Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Robert L. Carolla    417-269-4520      
Principal Investigator: Robert L. Carolla         
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Recruiting
Springfield, Missouri, United States, 65802
Contact: Robert L. Carolla    417-269-4520      
Principal Investigator: Robert L. Carolla         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nicola M. Spirtos    702-851-4672      
Principal Investigator: Nicola M. Spirtos         
United States, New Mexico
Southwest Gynecologic Oncology Associates Inc Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Teresa L. Rutledge    505-272-6972      
Principal Investigator: Teresa L. Rutledge         
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Teresa L. Rutledge    505-272-6972      
Principal Investigator: Teresa L. Rutledge         
Memorial Medical Center - Las Cruces Recruiting
Las Cruces, New Mexico, United States, 88011
Contact: Teresa L. Rutledge    505-272-6972      
Principal Investigator: Teresa L. Rutledge         
United States, New York
State University of New York Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Ovadia Abulafia    718-270-8216    sima.terebelo@downstate.edu   
Principal Investigator: Ovadia Abulafia         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mario M. Leitao    212-639-7202      
Principal Investigator: Mario M. Leitao         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Michael L. Pearl    800-862-2215      
Principal Investigator: Michael L. Pearl         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Linda Van Le    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Linda Van Le         
Park Ridge Hospital Breast Health Center Recruiting
Hendersonville, North Carolina, United States, 28792
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Vivian E. von Gruenigen    330-375-6101      
Principal Investigator: Vivian E. von Gruenigen         
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Jeffrey G. Bell    614-566-4475      
Principal Investigator: Jeffrey G. Bell         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: David M. O'Malley    866-627-7616    osu@emergingmed.com   
Principal Investigator: David M. O'Malley         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: John W. Moroney    937-208-2079      
Principal Investigator: John W. Moroney         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
Tulsa Cancer Institute Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Parviz Hanjani    215-481-2402      
Principal Investigator: Parviz Hanjani         
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822-2001
Contact: James R. Bosscher    570-271-5251    ehicks@sprg.mercy.net   
Principal Investigator: James R. Bosscher         
Geisinger Medical Center-Cancer Center Hazelton Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: James R. Bosscher    570-271-5251    ehicks@sprg.mercy.net   
Principal Investigator: James R. Bosscher         
Paoli Memorial Hospital Recruiting
Paoli, Pennsylvania, United States, 19301
Contact: Albert S. DeNittis    866-225-5654      
Principal Investigator: Albert S. DeNittis         
Geisinger Medical Group Recruiting
State College, Pennsylvania, United States, 16801
Contact: James R. Bosscher    570-271-5251    ehicks@sprg.mercy.net   
Principal Investigator: James R. Bosscher         
Geisinger Wyoming Valley Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: James R. Bosscher    570-271-5251    ehicks@sprg.mercy.net   
Principal Investigator: James R. Bosscher         
Mainline Health CCOP Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Albert S. DeNittis    866-225-5654      
Principal Investigator: Albert S. DeNittis         
Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Albert S. DeNittis    866-225-5654      
Principal Investigator: Albert S. DeNittis         
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Paul A. DiSilvestro    401-274-1122      
Principal Investigator: Paul A. DiSilvestro         
United States, South Carolina
AnMed Health Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
Gibbs Cancer Center-Pelham Recruiting
Greer, South Carolina, United States, 29651
Contact: Patricia C. Griffin    800-486-5941      
Principal Investigator: Patricia C. Griffin         
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
Upstate Carolina CCOP Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: David Griffin    864-512-1000      
Principal Investigator: David Griffin         
United States, South Dakota
Avera Cancer Institute Active, not recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David S. Miller    214-648-7097      
Principal Investigator: David S. Miller         
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: David S. Miller    214-648-7097      
Principal Investigator: David S. Miller         
Memorial Hermann Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: John L. Dalrymple    916-734-3089      
Principal Investigator: John L. Dalrymple         
M D Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
Scott and White Memorial Hospital Active, not recruiting
Temple, Texas, United States, 76508
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Weldon E. Chafe    804-628-1939      
Principal Investigator: Weldon E. Chafe         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: David M. Kushner    877-405-6866      
Principal Investigator: David M. Kushner         
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Anthony C. Evans    715-389-4457      
Principal Investigator: Anthony C. Evans         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: William H. Bradley    414-805-4380      
Principal Investigator: William H. Bradley         
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Scott A. Kamelle    414-649-7200      
Principal Investigator: Scott A. Kamelle         
Cancer Center of Western Wisconsin Recruiting
New Richmond, Wisconsin, United States, 54017
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Aurora Women's Pavilion of Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
India
Mayo Clinic Methodist Hospital Recruiting
Nagpur, India, 440 018
Contact: Jamie N. Bakkum-Gamez    507-538-7623      
Principal Investigator: Jamie N. Bakkum-Gamez         
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Richard Barakat Gynecologic Oncology Group
  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
Study First Received: August 8, 2009
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Lymphedema
Vulvar Neoplasms
Carcinoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Lymphatic Diseases
Vulvar Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 19, 2014