Phase
Condition
Vaginal Cancer
Dysfunctional Uterine Bleeding
Pelvic Cancer
Treatment
da Vinci
open surgery
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS),squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence ofdefinitive parametrial, vaginal, nodal or distant metastases on exam or imaging.Patients with tumor size less than or equal to 4 cm confirmed on MRI prior torandomization are eligible.
Patient must have uterine size <12 cm AND felt to be appropriate for vaginaldelivery of the specimen per investigator.
Patient must be suitable surgical candidate with preoperative assessments such aslabs and EKG performed per institutional standard and agree to be randomized toundergo open or robotic radical (or simple) hysterectomy. NOTE: Simple hysterectomy will be allowed in patients who meet the followingcriteria:
pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND
less than 50% stromal invasion on MRI if tumor present or less than 10 mm ofstromal invasion if an excisional (cold knife or LEEP) has been performed. Submission of source documents in the GOG Partners Source Document Portal will berequired prior to randomization for review and confirmation of simple hysterectomybeing met (see Section 6.0 for instructions).
Patient must be age 18 years or older.
Patient must have ECOG performance status 0-1.
Patient must have a negative urine pregnancy test within 30 days of surgery inpre-menopausal women.
Patient must have signed an approved informed consent and authorization permittingthe release of personal health information.
Exclusion
Exclusion Criteria:
Patients with any tumor histology other than those listed above, specificallyexcluding the following histologies: neuroendocrine, other adenocarcinoma (gastrictype, endometrioid, clear cell, serous, signet ring, minimal deviation)
Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
Patient with inability to receive an MRI.
Patients with a tumor size greater than 4cm or on MRI confirmed prior torandomization are excluded. Patients with definite evidence of vaginal/parametrialinvolvement on MRI are excluded; if MRI findings are not definitive, then clinicalexamination must also not reveal parametrial or vaginal extension).
Patients with evidence of metastatic disease (imaging or histologically positivelymph nodes).
Patients with a history of prior pelvic or abdominal radiotherapy.
Patients with a prior malignancy < 5 years from enrollment with the exception ofnon-melanoma skin cancer.
Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
Patient compliance and geographic proximity that do not allow adequate follow-up.
Patients with poorly controlled HIV with CD4 counts <500.
Study Design
Study Description
Connect with a study center
McGill University Health Centre-Glen Site
Montréal, Quebec H4A 3J1
CanadaActive - Recruiting
Centre Hospitalier De L'Universite De Montreal
Montréal, H2X 3E4
CanadaActive - Recruiting
Western Regional Medical Center LLC
Goodyear, Arizona 85338
United StatesActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
University of California San Diego Medical Center
Encinitas, California 92024
United StatesActive - Recruiting
City of Hope Orange County Lennar Foundation Cancer
Irvine, California 92618
United StatesActive - Recruiting
University of California San Diego Medical Center
La Jolla, California 92037
United StatesActive - Recruiting
University of California San Diego Moores Cancer Center
La Jolla, California 92093
United StatesActive - Recruiting
Hoag Gynecologic Oncology
Newport Beach, California 92633
United StatesActive - Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United StatesActive - Recruiting
Palo Alto Medical Foundation
Palo Alto, California 94040
United StatesActive - Recruiting
Stanford Hospital
Palo Alto, California 94305
United StatesActive - Recruiting
University of California San Diego Medical Center
San Diego, California 92103
United StatesActive - Recruiting
California Pacific Medical Center-Research Institute
San Francisco, California 91409
United StatesActive - Recruiting
City of Hope - Upland
Upland, California 91786
United StatesActive - Recruiting
University of California San Diego Medical Center
Vista, California 92081
United StatesActive - Recruiting
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut 06106
United StatesActive - Recruiting
Hartford Hospital
Hartford, Connecticut 06102
United StatesActive - Recruiting
Hartford Hospital
Hatford, Connecticut 06102
United StatesActive - Recruiting
Hartford Healthcare Medical Group-Manchester
Manchester, Connecticut 06042
United StatesActive - Recruiting
Harford HealthCare Cancer Institute at the Hospital of Central Connecticut
New Britain, Connecticut 06053
United StatesActive - Recruiting
Ascension Medical Group St. Vincent's Obstetrics and Gynecology
Jacksonville, Florida 32204
United StatesActive - Recruiting
Mercy Hospital
Miami, Florida 33173
United StatesActive - Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
United StatesActive - Recruiting
Mount Sinai Comprehensive Cancer Center
Miami, Florida 33140
United StatesSite Not Available
South Miami Hospital
Miami, Florida 33143
United StatesActive - Recruiting
Orlando Health Cancer Center
Orlando, Florida 32806
United StatesSite Not Available
Orlando Health Winnie Palmer Hospital for Woman and Babies
Orlando, Florida 32806
United StatesActive - Recruiting
Tampa General Hospital
Tampa, Florida 33606
United StatesSite Not Available
Georgian Cancer Center at Augusta University
Augusta, Georgia 30912
United StatesActive - Recruiting
Southeastern Regional Medical Center LLC
Newnan, Georgia 30265
United StatesActive - Recruiting
St. Vincent Hospital and Health Care Center Inc
Indianapolis, Indiana 46260
United StatesSite Not Available
St. Vincent Hospital and Health Care Center, Inc
Indianapolis, Indiana 46260
United StatesSite Not Available
St. Elizabeth Healthcare
Edgewood, Kentucky 41017
United StatesActive - Recruiting
Baptist Health
Lexington, Kentucky 40503
United StatesActive - Recruiting
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesActive - Recruiting
LSU Health New Orleans
New Orleans, Louisiana 70112
United StatesActive - Recruiting
Willis-Knighton Physician Network Gynecologic Oncology Associates
Shreveport, Louisiana 71118
United StatesActive - Recruiting
Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology
Scarborough, Maine 04074
United StatesActive - Recruiting
Baystate Medical Center
Springfield, Massachusetts 01199
United StatesSite Not Available
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Minnesota Oncology Hematology
Minneapolis, Minnesota 55404
United StatesActive - Recruiting
David C. Pratt Center
Saint Louis, Missouri 63141
United StatesSite Not Available
David C. Pratt Center
St. Louis, Missouri 63141
United StatesActive - Recruiting
Center of Hope
Reno, Nevada 89511
United StatesActive - Recruiting
Memorial Sloan Kettering (Basking Ridge)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering (Bergen)
Montvale, New Jersey 07645
United StatesActive - Recruiting
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87131
United StatesActive - Recruiting
Northwell Health/South Shore University Hospital
Bay Shore, New York 11706
United StatesActive - Recruiting
Northwell Health Physician Partners/Gynecological Oncology at Brightwaters
Brightwaters, New York 11718
United StatesActive - Recruiting
Laura and Issac Perlmutter Cancer Center at NYU Langone
Brooklyn, New York 11220
United StatesActive - Recruiting
NYU Langone Ambulatory Care Bay Ridge
Brooklyn, New York 11220
United StatesActive - Recruiting
NYU Langone Hospital-Brooklym
Brooklyn, New York 11220
United StatesActive - Recruiting
Memorial Sloan Kettering (Commack)
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering (Westchester)
Harrison, New York 10604
United StatesActive - Recruiting
Northwell Health/Huntington Hospital
Huntington, New York 11743
United StatesActive - Recruiting
Memorial Sloan Kettering (Monmouth)
Middletown, New York 07748
United StatesActive - Recruiting
NHPP/Gynecologic Oncology at New Hyde Park
New Hyde Park, New York 11042
United StatesActive - Recruiting
Northwell Health/Long Island Jewish Medical Center
New Hyde Park, New York 11040
United StatesActive - Recruiting
Josie Robertson Surgery Center
New York, New York 10065
United StatesActive - Recruiting
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United StatesActive - Recruiting
Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street
New York, New York 10016
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center (Main Campus)
New York, New York 10065
United StatesActive - Recruiting
NYU Langone Medical Center (Tisch Hospital)
New York, New York 10016
United StatesActive - Recruiting
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering (Nassau)
Uniondale, New York 11553
United StatesActive - Recruiting
Novant Health Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Duke Cancer Center
Durham, North Carolina 27710
United StatesActive - Recruiting
Duke University Hospital
Durham, North Carolina 27705
United StatesActive - Recruiting
Novant Health Cancer Institute
Greensboro, North Carolina 27403
United StatesActive - Recruiting
Novant Health Cancer Institute
Kernersville, North Carolina 27284
United StatesActive - Recruiting
Novant Health Cancer Institute
Mount Airy, North Carolina 27030
United StatesActive - Recruiting
Novant Health Cancer Institute
N. Wilkesboro, North Carolina 28659
United StatesActive - Recruiting
Novant Health Cancer Institute
North Wilkesboro, North Carolina 28659
United StatesSite Not Available
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina 28374
United StatesActive - Recruiting
Novant Health Cancer Institute
Statesville, North Carolina 28625
United StatesActive - Recruiting
Novant Health Cancer Institute
Thomasville, North Carolina 27360
United StatesActive - Recruiting
Novant Health Cancer Institute
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Summa Health Jean and Milton Copper Pavilion
Akron, Ohio 44304
United StatesActive - Recruiting
Summa Health Jean and Milton Copper Pavillion
Akron, Ohio 44304
United StatesActive - Recruiting
TriHealth Cancer Institute-Good Samaritan Hospital
Cincinnati, Ohio 45220
United StatesActive - Recruiting
TriHealth Cancer Institute-Thomas Comprehensive Care Center
Cincinnati, Ohio 45220
United StatesActive - Recruiting
University of Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesActive - Recruiting
OSU Wexner Medical Center Hospital East
Columbus, Ohio 43203
United StatesActive - Recruiting
OSU Wexner Medical Center Martha Morehouse Outpatient Care
Columbus, Ohio 43221
United StatesActive - Recruiting
OSU Wexner Medical Center Outpatient Care East
Columbus, Ohio 43203
United StatesActive - Recruiting
OSU Wexner Medical Center Outpatient Care Gahanna
Columbus, Ohio 43230
United StatesActive - Recruiting
OSU Wexner Medical Center Outpatient Care Upper Arlington
Columbus, Ohio 43221
United StatesActive - Recruiting
OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio 43212
United StatesActive - Recruiting
OSU Wexner Medical Center University Hospital
Columbus, Ohio 43210
United StatesActive - Recruiting
OSU Wexner Medical Center Outpatient Care Dublin
Dublin, Ohio 43016
United StatesActive - Recruiting
JamesCare Gynecologic Oncology at Mill Run
Hilliard, Ohio 43026
United StatesActive - Recruiting
Kettering Health Cancer Center
Kettering, Ohio 45429
United StatesActive - Recruiting
OSU Wexner Medical Center Outpatient Care Lewis Center
Lewis Center, Ohio 43035
United StatesActive - Recruiting
OSU Wexner Medical Center Outpatient Care New Albany
Westerville, Ohio 43081
United StatesActive - Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Legacy Good Samaritan Medical Center-Gynecological Oncology Group
Portland, Oregon 97210
United StatesSite Not Available
Providence Center Institute Franz Clinic
Portland, Oregon 97213
United StatesActive - Recruiting
Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology
Tualatin, Oregon 97062
United StatesSite Not Available
Abington Memorial Hospital
Abington, Pennsylvania 19001
United StatesActive - Recruiting
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
AHN West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
Magee - Womens Hospital of UPMC
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Asplundh Cancer Pavillion
Willow Grove, Pennsylvania 19090
United StatesActive - Recruiting
Women's and Infants Hospital of Rhode Island Program in Women's Oncology
Providence, Rhode Island 02905
United StatesActive - Recruiting
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee 37403
United StatesActive - Recruiting
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee 38119
United StatesActive - Recruiting
Texas Oncology-Austin
Austin, Texas 78758
United StatesActive - Recruiting
Texas Oncology- GYN ONC DFWW
Bedford, Texas 76022
United StatesActive - Recruiting
Texas Oncology-DFWW
Bedford, Texas 76022
United StatesActive - Recruiting
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesActive - Recruiting
University of Texas Southwestern Medical Center-Simmons Cancer Center
Dallas, Texas 75390
United StatesActive - Recruiting
University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital
Dallas, Texas 75390
United StatesActive - Recruiting
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
Dallas, Texas 75390
United StatesActive - Recruiting
Texas Oncology
Fort Worth, Texas 76104
United StatesActive - Recruiting
Texas Oncology-GYN ONC DFWW
Fort Worth, Texas 76104
United StatesActive - Recruiting
Texas Oncology-San Antonio
San Antonio, Texas 78240
United StatesActive - Recruiting
Texas Oncology-The Woodlands, Gynecologic Oncology
The Woodlands, Texas 77380
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22903
United StatesActive - Recruiting
VCU Health at GreenGate
Henrico, Virginia 23233
United StatesActive - Recruiting
VCU Health Emergency Center at New Kent
Quinton, Virginia 23141
United StatesActive - Recruiting
VCU Health Short Pump Pavillion
Richmond, Virginia 23233
United StatesActive - Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
United StatesActive - Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23219
United StatesActive - Recruiting
Virginia Commonwealth University-Main Hospital
Richmond, Virginia 23298
United StatesActive - Recruiting
VCU Health at Tappahannock Hospital
Tappahannock, Virginia 25560
United StatesActive - Recruiting
VCU Health-William and Mary
Williamsburg, Virginia 23185
United StatesActive - Recruiting
Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology
Vancouver, Washington 98686
United StatesActive - Recruiting
West Virginia
Morgantown, West Virginia 26506
United StatesActive - Recruiting
West Virginia University
Morgantown, West Virginia 26506
United StatesActive - Recruiting
University of Wisconsin Clinical Science Center
Madison, Wisconsin 53792
United StatesActive - Recruiting
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