Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy With Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (≤ 2CM) Cervical Cancer

Who is this study for? Adult patients with Cervical Squamous Cell Carcinoma that have undergone Loop Electrosurgical Excision Procedure
Status: Active_not_recruiting
Location: See all (185) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical trial studies the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer. Studying quality-of-life in patients undergoing surgery for cervical cancer may help determine the intermediate-term and long-term effects of surgery.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient must consent for the appropriate surgery

• Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion \[LVSI\]+), IA2, and IB1 (tumor size \[maximum visible or palpable\]) =\< 2 cm), any grade

• All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =\< 10 mm

• Patients must have no evidence of metastasis on positron emission tomography (PET) scan or magnetic resonance imaging (MRI) or computed tomography (CT) scan of the pelvis and chest imaging

• Patients who have met the pre-entry requirements

• Patients must have signed an approved informed consent and authorization permitting release of personal health information

• Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

Locations
United States
Arizona
Cancer Center at Saint Joseph's
Phoenix
Saint Joseph's Hospital and Medical Center
Phoenix
California
Sutter Auburn Faith Hospital
Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Mills-Peninsula Medical Center
Burlingame
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
Eden Hospital Medical Center
Castro Valley
Sutter Davis Hospital
Davis
Palo Alto Medical Foundation-Fremont
Fremont
UC San Diego Moores Cancer Center
La Jolla
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Memorial Medical Center
Modesto
Palo Alto Medical Foundation-Camino Division
Mountain View
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
Palo Alto Medical Foundation Health Care
Palo Alto
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
Sutter Roseville Medical Center
Roseville
Sutter Medical Center Sacramento
Sacramento
California Pacific Medical Center-Pacific Campus
San Francisco
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz
Sutter Pacific Medical Foundation
Santa Rosa
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Olive View-University of California Los Angeles Medical Center
Sylmar
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville
Sutter Solano Medical Center/Cancer Center
Vallejo
Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach
Jackson Memorial Hospital-Holtz Children's Hospital
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
AdventHealth Orlando
Orlando
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation
Georgia
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Honolulu
Queen's Medical Center
Honolulu
University of Hawaii Cancer Center
Honolulu
Illinois
Northwestern Medicine Cancer Center Delnor
Geneva
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale
Good Samaritan Regional Health Center
Mount Vernon
Northwestern Medicine Cancer Center Warrenville
Warrenville
Kansas
Cancer Center of Kansas - Chanute
Chanute
Cancer Center of Kansas - Dodge City
Dodge City
Cancer Center of Kansas - El Dorado
El Dorado
Cancer Center of Kansas - Fort Scott
Fort Scott
Cancer Center of Kansas-Independence
Independence
Cancer Center of Kansas-Kingman
Kingman
Lawrence Memorial Hospital
Lawrence
Cancer Center of Kansas-Liberal
Liberal
Cancer Center of Kansas-Manhattan
Manhattan
Cancer Center of Kansas - McPherson
Mcpherson
Cancer Center of Kansas - Newton
Newton
Cancer Center of Kansas - Parsons
Parsons
Cancer Center of Kansas - Pratt
Pratt
Cancer Center of Kansas - Salina
Salina
Cancer Center of Kansas - Wellington
Wellington
Ascension Via Christi Hospitals Wichita
Wichita
Associates In Womens Health
Wichita
Cancer Center of Kansas - Wichita
Wichita
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita
Cancer Center of Kansas - Winfield
Winfield
Kentucky
Baptist Health Corbin
Corbin
Baptist Health Lexington
Lexington
Baptist Health Madisonville/Merle Mahr Cancer Center
Madisonville
Baptist Health Paducah
Paducah
Louisiana
Hematology/Oncology Clinic PLLC
Baton Rouge
Woman's Hospital
Baton Rouge
Tulane University Health Sciences Center
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Brigham and Women's Hospital
Boston
Dana-Farber Cancer Institute
Boston
Baystate Medical Center
Springfield
Michigan
Henry Ford Hospital
Detroit
Minnesota
Fairview Ridges Hospital
Burnsville
Mercy Hospital
Coon Rapids
Fairview Southdale Hospital
Edina
Unity Hospital
Fridley
Hutchinson Area Health Care
Hutchinson
Fairview Clinics and Surgery Center Maple Grove
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
New Ulm Medical Center
New Ulm
North Memorial Medical Health Center
Robbinsdale
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Fairview Lakes Medical Center
Wyoming
Missouri
Mercy Hospital Joplin
Joplin
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Mercy Hospital Saint Louis
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
Wake Forest University Health Sciences
Winston-salem
Nebraska
Nebraska Methodist Hospital
Omaha
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Cooper Hospital University Medical Center
Camden
Memorial Sloan Kettering Monmouth
Middletown
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees
Nevada
Women's Cancer Center of Nevada
Las Vegas
New York
Memorial Sloan Kettering Commack
Commack
Memorial Sloan Kettering Westchester
Harrison
Memorial Sloan Kettering Cancer Center
New York
University of Rochester
Rochester
Memorial Sloan Kettering Nassau
Uniondale
Ohio
Summa Health System - Akron Campus
Akron
Strecker Cancer Center-Belpre
Belpre
Aultman Health Foundation
Canton
Adena Regional Medical Center
Chillicothe
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
Columbus Oncology and Hematology Associates Inc
Columbus
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Mount Carmel East Hospital
Columbus
Mount Carmel Health Center West
Columbus
Ohio State University Comprehensive Cancer Center
Columbus
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Grandview Hospital
Dayton
Delaware Health Center-Grady Cancer Center
Delaware
Delaware Radiation Oncology
Delaware
Grady Memorial Hospital
Delaware
Dublin Methodist Hospital
Dublin
Central Ohio Breast and Endocrine Surgery
Gahanna
Mount Carmel Grove City Hospital
Grove City
Fairfield Medical Center
Lancaster
Saint Rita's Medical Center
Lima
OhioHealth Mansfield Hospital
Mansfield
Marietta Memorial Hospital
Marietta
OhioHealth Marion General Hospital
Marion
Hillcrest Hospital Cancer Center
Mayfield Heights
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor
Knox Community Hospital
Mount Vernon
Licking Memorial Hospital
Newark
Newark Radiation Oncology
Newark
Mercy Health Perrysburg Cancer Center
Perrysburg
Southern Ohio Medical Center
Portsmouth
ProMedica Flower Hospital
Sylvania
Mercy Health - Saint Anne Hospital
Toledo
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo
Saint Vincent Mercy Medical Center
Toledo
Saint Ann's Hospital
Westerville
Genesis Healthcare System Cancer Care Center
Zanesville
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Pennsylvania
Jefferson Abington Hospital
Abington
Paoli Memorial Hospital
Paoli
Asplundh Cancer Pavilion
Willow Grove
Lankenau Medical Center
Wynnewood
Rhode Island
Women and Infants Hospital
Providence
Texas
Parkland Memorial Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Memorial Hermann Texas Medical Center
Houston
Virginia
Naval Medical Center - Portsmouth
Portsmouth
Virginia Commonwealth University/Massey Cancer Center
Richmond
Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee
ProHealth D N Greenwald Center
Mukwonago
Cancer Center of Western Wisconsin
New Richmond
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
ProHealth Waukesha Memorial Hospital
Waukesha
UW Cancer Center at ProHealth Care
Waukesha
Aurora West Allis Medical Center
West Allis
West Virginia
Monongalia Hospital
Morgantown
Other Locations
Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto
Republic of Korea
Gachon University Gil Hospital
Incheon
Seoul National University Bundang Hospital
Seongnam City
Asan Medical Center
Seoul
Catholic University of Korea-Seoul Saint Mary's Hospital
Seoul
Gangnam Severance Hospital
Seoul
Korea Cancer Center Hospital
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Yonsei University Health System-Severance Hospital
Seoul
Time Frame
Start Date: 2013-06-05
Completion Date: 2025-12-01
Participants
Target number of participants: 224
Treatments
Experimental: Treatment (cone biopsy/lymphadenectomy or hysterectomy)
Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.
Sponsors
Leads: GOG Foundation
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov