A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer (ROCC)

Status: Recruiting
Location: See all (136) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a randomized controlled trial to compare survival for patients who undergoe robotic assisted laparoscopy versus open hysterectomy and lymph node assessment for the treatment of early stage cervical cancer.

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

• 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 of definitive 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 to randomization are eligible.

• Patient must have uterine size \<12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.

• Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard and agree to be randomized to undergo open or robotic radical (or simple) hysterectomy.

• NOTE: Simple hysterectomy will be allowed in patients who meet the following criteria:

⁃ 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 of stromal invasion if an excisional (cold knife or LEEP) has been performed.

• Submission of source documents in the GOG Partners Source Document Portal will be required prior to randomization for review and confirmation of simple hysterectomy being 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 in pre-menopausal women.

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

Locations
United States
Arizona
Western Regional Medical Center LLC
RECRUITING
Goodyear
California
City of Hope
RECRUITING
Duarte
University of California San Diego Medical Center
RECRUITING
Encinitas
City of Hope Orange County Lennar Foundation Cancer
RECRUITING
Irvine
University of California San Diego Medical Center
RECRUITING
La Jolla
University of California San Diego Moores Cancer Center
RECRUITING
La Jolla
Hoag Gynecologic Oncology
RECRUITING
Newport Beach
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
Palo Alto Medical Foundation
RECRUITING
Palo Alto
Stanford Hospital
RECRUITING
Palo Alto
University of California San Diego Medical Center
RECRUITING
San Diego
California Pacific Medical Center-Research Institute
RECRUITING
San Francisco
City of Hope - Upland
RECRUITING
Upland
University of California San Diego Medical Center
RECRUITING
Vista
Connecticut
Hartford Healthcare Cancer Institute at Hartford Hospital
RECRUITING
Hartford
Hartford Hospital
RECRUITING
Hatford
Hartford Healthcare Medical Group-Manchester
RECRUITING
Manchester
Harford HealthCare Cancer Institute at the Hospital of Central Connecticut
RECRUITING
New Britain
Florida
Ascension Medical Group St. Vincent's Obstetrics and Gynecology
RECRUITING
Jacksonville
Mercy Hospital
RECRUITING
Miami
Mercy Hospital
RECRUITING
Miami
Miami Cancer Institute at Baptist Health, Inc.
RECRUITING
Miami
Miami Cancer Institute at Baptist Health, Inc.
RECRUITING
Miami
Mount Sinai Comprehensive Cancer Center
WITHDRAWN
Miami
South Miami Hospital
RECRUITING
Miami
South Miami Hospital
RECRUITING
Miami
Orlando Health Cancer Center
WITHDRAWN
Orlando
Orlando Health Winnie Palmer Hospital for Woman and Babies
RECRUITING
Orlando
Tampa General Hospital
WITHDRAWN
Tampa
Georgia
Georgian Cancer Center at Augusta University
RECRUITING
Augusta
Southeastern Regional Medical Center LLC
RECRUITING
Newnan
Indiana
St. Vincent Hospital and Health Care Center Inc
WITHDRAWN
Indianapolis
St. Vincent Hospital and Health Care Center, Inc
WITHDRAWN
Indianapolis
Kentucky
St. Elizabeth Healthcare
RECRUITING
Edgewood
Baptist Health
RECRUITING
Lexington
Baptist Health Lexington
RECRUITING
Lexington
Louisiana
LSU Health New Orleans
RECRUITING
New Orleans
Willis-Knighton Physician Network Gynecologic Oncology Associates
RECRUITING
Shreveport
Massachusetts
Baystate Medical Center
WITHDRAWN
Springfield
Maine
Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology
RECRUITING
Scarborough
Minnesota
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
RECRUITING
Minneapolis
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
RECRUITING
Minneapolis
Minnesota Oncology Hematology
RECRUITING
Minneapolis
Missouri
David C. Pratt Center
RECRUITING
St Louis
North Carolina
Novant Health Cancer Institute
RECRUITING
Charlotte
Duke Cancer Center
RECRUITING
Durham
Duke Cancer Center
RECRUITING
Durham
Duke University Hospital
RECRUITING
Durham
Novant Health Cancer Institute
RECRUITING
Greensboro
Novant Health Cancer Institute
RECRUITING
Kernersville
Novant Health Cancer Institute
RECRUITING
Mount Airy
Novant Health Cancer Institute
RECRUITING
North Wilkesboro
FirstHealth Outpatient Cancer Center
RECRUITING
Pinehurst
Novant Health Cancer Institute
RECRUITING
Statesville
Novant Health Cancer Institute
RECRUITING
Thomasville
Novant Health Cancer Institute
RECRUITING
Winston-salem
New Jersey
Memorial Sloan Kettering (Basking Ridge)
RECRUITING
Basking Ridge
Memorial Sloan Kettering (Bergen)
RECRUITING
Montvale
New Mexico
University of New Mexico Comprehensive Cancer Center
RECRUITING
Albuquerque
Nevada
Center of Hope
RECRUITING
Reno
New York
Northwell Health/South Shore University Hospital
RECRUITING
Bay Shore
Northwell Health Physician Partners/Gynecological Oncology at Brightwaters
RECRUITING
Brightwaters
Laura and Issac Perlmutter Cancer Center at NYU Langone
RECRUITING
Brooklyn
NYU Langone Ambulatory Care Bay Ridge
RECRUITING
Brooklyn
NYU Langone Hospital-Brooklym
RECRUITING
Brooklyn
Memorial Sloan Kettering (Commack)
RECRUITING
Commack
Memorial Sloan Kettering (Westchester)
RECRUITING
Harrison
Northwell Health/Huntington Hospital
RECRUITING
Huntington
Memorial Sloan Kettering (Monmouth)
RECRUITING
Middletown
NHPP/Gynecologic Oncology at New Hyde Park
RECRUITING
New Hyde Park
Northwell Health/Long Island Jewish Medical Center
RECRUITING
New Hyde Park
Josie Robertson Surgery Center
RECRUITING
New York
Laura and Issac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street
RECRUITING
New York
Memorial Sloan Kettering Cancer Center (Main Campus)
RECRUITING
New York
NYU Langone Medical Center (Tisch Hospital)
RECRUITING
New York
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
RECRUITING
New York
Memorial Sloan Kettering (Nassau)
RECRUITING
Uniondale
Ohio
Summa Health Jean and Milton Copper Pavilion
RECRUITING
Akron
Summa Health Jean and Milton Copper Pavillion
RECRUITING
Akron
TriHealth Cancer Institute-Good Samaritan Hospital
RECRUITING
Cincinnati
TriHealth Cancer Institute-Thomas Comprehensive Care Center
RECRUITING
Cincinnati
University of Cleveland Medical Center
RECRUITING
Cleveland
James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
OSU Wexner Medical Center Hospital East
RECRUITING
Columbus
OSU Wexner Medical Center Martha Morehouse Outpatient Care
RECRUITING
Columbus
OSU Wexner Medical Center Outpatient Care East
RECRUITING
Columbus
OSU Wexner Medical Center Outpatient Care Gahanna
RECRUITING
Columbus
OSU Wexner Medical Center Outpatient Care Upper Arlington
RECRUITING
Columbus
OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center
RECRUITING
Columbus
OSU Wexner Medical Center University Hospital
RECRUITING
Columbus
OSU Wexner Medical Center Outpatient Care Dublin
RECRUITING
Dublin
JamesCare Gynecologic Oncology at Mill Run
RECRUITING
Hilliard
Kettering Health Cancer Center
RECRUITING
Kettering
OSU Wexner Medical Center Outpatient Care Lewis Center
RECRUITING
Lewis Center
OSU Wexner Medical Center Outpatient Care New Albany
RECRUITING
Westerville
Oklahoma
Stephenson Cancer Center
RECRUITING
Oklahoma City
Oregon
Legacy Good Samaritan Medical Center-Gynecological Oncology Group
WITHDRAWN
Portland
Providence Center Institute Franz Clinic
RECRUITING
Portland
Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology
WITHDRAWN
Tualatin
Pennsylvania
Abington Memorial Hospital
RECRUITING
Abington
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
RECRUITING
Philadelphia
AHN West Penn Hospital
RECRUITING
Pittsburgh
Magee - Womens Hospital of UPMC
RECRUITING
Pittsburgh
Asplundh Cancer Pavillion
RECRUITING
Willow Grove
Rhode Island
Women's and Infants Hospital of Rhode Island Program in Women's Oncology
RECRUITING
Providence
Tennessee
Chattanooga's Program in Women's Oncology
RECRUITING
Chattanooga
The West Clinic, PLLC dba West Cancer Center
RECRUITING
Germantown
Texas
Texas Oncology-Austin
RECRUITING
Austin
Texas Oncology- GYN ONC DFWW
RECRUITING
Bedford
Texas Oncology-DFWW
RECRUITING
Bedford
Texas Oncology- Baylor Charles A. Sammons Cancer Center
RECRUITING
Dallas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
University of Texas Southwestern Medical Center-Simmons Cancer Center
RECRUITING
Dallas
University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital
RECRUITING
Dallas
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
RECRUITING
Dallas
Texas Oncology
RECRUITING
Fort Worth
Texas Oncology-GYN ONC DFWW
RECRUITING
Fort Worth
Texas Oncology-San Antonio
RECRUITING
San Antonio
Texas Oncology-The Woodlands, Gynecologic Oncology
RECRUITING
The Woodlands
Virginia
University of Virginia
RECRUITING
Charlottesville
University of Virginia Comprehensive Cancer Center
RECRUITING
Charlottesville
VCU Health at GreenGate
RECRUITING
Henrico
VCU Health Emergency Center at New Kent
RECRUITING
Quinton
VCU Health Short Pump Pavillion
RECRUITING
Richmond
VCU Massey Cancer Center at Stony Point
RECRUITING
Richmond
Virginia Commonwealth University Massey Cancer Center
RECRUITING
Richmond
Virginia Commonwealth University-Main Hospital
RECRUITING
Richmond
VCU Health at Tappahannock Hospital
RECRUITING
Tappahannock
VCU Health-William and Mary
RECRUITING
Williamsburg
Washington
Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology
RECRUITING
Vancouver
Wisconsin
University of Wisconsin Clinical Science Center
RECRUITING
Madison
West Virginia
West Virginia
RECRUITING
Morgantown
West Virginia University
RECRUITING
Morgantown
Other Locations
Canada
Centre Hospitalier De L'Universite De Montreal
RECRUITING
Montreal
McGill University Health Centre-Glen Site
RECRUITING
Montreal
Contact Information
Primary
Jennifer Klein, MEd
jklein@gog.org
215-854-0770
Time Frame
Start Date: 2022-03-22
Estimated Completion Date: 2029-08
Participants
Target number of participants: 840
Treatments
Active_comparator: Open radical or simple hysterectomy
Experimental: Robotic radical or simple hysterectomy
Related Therapeutic Areas
Sponsors
Leads: GOG Foundation
Collaborators: Intuitive Foundation

This content was sourced from clinicaltrials.gov