A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer (ROCC)
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.
Detailed description
This is a multi-center, open-label, randomized, non-inferiority clinical trial with the hypothesis that robotically assisted hysterectomy with tumor containment prior to colpotomy is non-inferior to abdominal hysterectomy with respect to disease free survival. At the commencement of surgery, a thorough inspection of all peritoneal surfaces should be performed. The location of any suspected metastatic disease should be documented in the operative report and a biopsy should be performed to confirm the diagnosis. If intraperitoneal disease is detected, the radical hysterectomy should be abandoned. In patients with macroscopic evidence of metastatic disease to the lymph nodes, intraoperative frozen section should be performed to confirm the presence of metastatic disease. Intraoperative management will be left to the discretion of the surgeon. Patients who have confirmed macroscopic lymph node metastases intraoperatively will be excluded from final analysis and replaced due to the controversy surrounding the decision to perform a radical hysterectomy in this setting. Patients in whom the hysterectomy is abandoned will be deemed non-evaluable and excluded from final analysis and will be replaced. For all patients, the surgeon should document operative time from incision to close, detailed description of operative findings, intraoperative complications, and blood loss. For patients randomized to the robotic arm, the surgeon should document the use of and specify the type of vaginal manipulator and the reason for conversion to laparotomy (if applicable). Transcervical manipulators are not permitted. Standard arm: Radical or simple hysterectomy is performed as per standard technique (peon radical hysterectomy (Piver type 2 or 3 or Querleu \& Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Prior to colpotomy, the vagina must be closed over the tumor (ie, Wertheim clamps, contour stapling device). Study arm: Radical or simple hysterectomy is performed as per standard robotic technique (Querleu \& Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Colpotomy may be made intracorporally or vaginally. Vagina must be closed prior to intracorporeal colpotomy (see below, #10)
Arms & interventions
- Deviceda Vinci
Minimally invasive robotic-assisted radical or simple hysterectomy
- Otheropen surgery
open radical or simple hysterectomy
Outcome measures
Primary
Survival
3 year disease-free survival
Time frame: 36 months
Eligibility criteria
Study locations (134)
Western Regional Medical Center LLC
Goodyear, Arizona, 85338
City of Hope
Duarte, California, 91010
University of California San Diego Medical Center
Encinitas, California, 92024
City of Hope Orange County Lennar Foundation Cancer
Irvine, California, 92618
University of California San Diego Medical Center
La Jolla, California, 92037
University of California San Diego Moores Cancer Center
La Jolla, California, 92093
Hoag Gynecologic Oncology
Newport Beach, California, 92633
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Palo Alto Medical Foundation
Palo Alto, California, 94040
Stanford Hospital
Palo Alto, California, 94305
University of California San Diego Medical Center
San Diego, California, 92103
California Pacific Medical Center-Research Institute
San Francisco, California, 91409
City of Hope - Upland
Upland, California, 91786
University of California San Diego Medical Center
Vista, California, 92081
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06106
Hartford Hospital
Hatford, Connecticut, 06102
Hartford Healthcare Medical Group-Manchester
Manchester, Connecticut, 06042
Harford HealthCare Cancer Institute at the Hospital of Central Connecticut
New Britain, Connecticut, 06053
Ascension Medical Group St. Vincent's Obstetrics and Gynecology
Jacksonville, Florida, 32204
Mercy Hospital
Miami, Florida, 33133
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
South Miami Hospital
Miami, Florida, 33143
South Miami Hospital
Miami, Florida, 33143
Mercy Hospital
Miami, Florida, 33173
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Orlando Health Cancer Center
Orlando, Florida, 32806
Orlando Health Winnie Palmer Hospital for Woman and Babies
Orlando, Florida, 32806
Tampa General Hospital
Tampa, Florida, 33606
Georgian Cancer Center at Augusta University
Augusta, Georgia, 30912
Southeastern Regional Medical Center LLC
Newnan, Georgia, 30265
St. Vincent Hospital and Health Care Center Inc
Indianapolis, Indiana, 46260
St. Vincent Hospital and Health Care Center, Inc
Indianapolis, Indiana, 46260
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
Baptist Health Lexington
Lexington, Kentucky, 40503
Baptist Health
Lexington, Kentucky, 40503
LSU Health New Orleans
New Orleans, Louisiana, 70112
Willis-Knighton Physician Network Gynecologic Oncology Associates
Shreveport, Louisiana, 71118
Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology
Scarborough, Maine, 04074
Baystate Medical Center
Springfield, Massachusetts, 01199
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota, 55455
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota, 55455
David C. Pratt Center
St Louis, Missouri, 63141
Center of Hope
Reno, Nevada, 89511
Memorial Sloan Kettering (Basking Ridge)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering (Bergen)
Montvale, New Jersey, 07645
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
Northwell Health/South Shore University Hospital
Bay Shore, New York, 11706
Northwell Health Physician Partners/Gynecological Oncology at Brightwaters
Brightwaters, New York, 11718
Laura and Issac Perlmutter Cancer Center at NYU Langone
Brooklyn, New York, 11220
NYU Langone Ambulatory Care Bay Ridge
Brooklyn, New York, 11220
NYU Langone Hospital-Brooklym
Brooklyn, New York, 11220
Memorial Sloan Kettering (Commack)
Commack, New York, 11725
Memorial Sloan Kettering (Westchester)
Harrison, New York, 10604
Northwell Health/Huntington Hospital
Huntington, New York, 11743
Memorial Sloan Kettering (Monmouth)
Middletown, New York, 07748
Northwell Health/Long Island Jewish Medical Center
New Hyde Park, New York, 11040
NHPP/Gynecologic Oncology at New Hyde Park
New Hyde Park, New York, 11042
Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street
New York, New York, 10016
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
NYU Langone Medical Center (Tisch Hospital)
New York, New York, 10016
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York, 10029
Josie Robertson Surgery Center
New York, New York, 10065
Memorial Sloan Kettering Cancer Center (Main Campus)
New York, New York, 10065
Memorial Sloan Kettering (Nassau)
Uniondale, New York, 11553
Novant Health Cancer Institute
Charlotte, North Carolina, 28204
Duke University Hospital
Durham, North Carolina, 27705
Duke Cancer Center
Durham, North Carolina, 27710
Duke Cancer Center
Durham, North Carolina, 27710
Novant Health Cancer Institute
Greensboro, North Carolina, 27403
Novant Health Cancer Institute
Kernersville, North Carolina, 27284
Novant Health Cancer Institute
Mount Airy, North Carolina, 27030
Novant Health Cancer Institute
North Wilkesboro, North Carolina, 28659
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374
Novant Health Cancer Institute
Statesville, North Carolina, 28625
Novant Health Cancer Institute
Thomasville, North Carolina, 27360
Novant Health Cancer Institute
Winston-Salem, North Carolina, 27103
Summa Health Jean and Milton Copper Pavilion
Akron, Ohio, 44304
Summa Health Jean and Milton Copper Pavillion
Akron, Ohio, 44304
TriHealth Cancer Institute-Good Samaritan Hospital
Cincinnati, Ohio, 45220
TriHealth Cancer Institute-Thomas Comprehensive Care Center
Cincinnati, Ohio, 45220
University of Cleveland Medical Center
Cleveland, Ohio, 44106
OSU Wexner Medical Center Hospital East
Columbus, Ohio, 43203
OSU Wexner Medical Center Outpatient Care East
Columbus, Ohio, 43203
James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
OSU Wexner Medical Center University Hospital
Columbus, Ohio, 43210
OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
OSU Wexner Medical Center Martha Morehouse Outpatient Care
Columbus, Ohio, 43221
OSU Wexner Medical Center Outpatient Care Upper Arlington
Columbus, Ohio, 43221
OSU Wexner Medical Center Outpatient Care Gahanna
Columbus, Ohio, 43230
OSU Wexner Medical Center Outpatient Care Dublin
Dublin, Ohio, 43016
JamesCare Gynecologic Oncology at Mill Run
Hilliard, Ohio, 43026
Kettering Health Cancer Center
Kettering, Ohio, 45429
OSU Wexner Medical Center Outpatient Care Lewis Center
Lewis Center, Ohio, 43035
OSU Wexner Medical Center Outpatient Care New Albany
Westerville, Ohio, 43081
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Legacy Good Samaritan Medical Center-Gynecological Oncology Group
Portland, Oregon, 97210
Providence Center Institute Franz Clinic
Portland, Oregon, 97213
Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology
Tualatin, Oregon, 97062
Abington Memorial Hospital
Abington, Pennsylvania, 19001
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Magee - Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Asplundh Cancer Pavillion
Willow Grove, Pennsylvania, 19090
Women's and Infants Hospital of Rhode Island Program in Women's Oncology
Providence, Rhode Island, 02905
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, 37403
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38119
Texas Oncology-Austin
Austin, Texas, 78758
Texas Oncology- GYN ONC DFWW
Bedford, Texas, 76022
Texas Oncology-DFWW
Bedford, Texas, 76022
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
University of Texas Southwestern Medical Center-Simmons Cancer Center
Dallas, Texas, 75390
University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital
Dallas, Texas, 75390
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
Dallas, Texas, 75390
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Texas Oncology-GYN ONC DFWW
Fort Worth, Texas, 76104
Texas Oncology
Fort Worth, Texas, 76104
Texas Oncology-San Antonio
San Antonio, Texas, 78240
Texas Oncology-The Woodlands, Gynecologic Oncology
The Woodlands, Texas, 77380
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
University of Virginia
Charlottesville, Virginia, 22903
VCU Health at GreenGate
Henrico, Virginia, 23233
VCU Health Emergency Center at New Kent
Quinton, Virginia, 23141
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23219
VCU Health Short Pump Pavillion
Richmond, Virginia, 23233
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Virginia Commonwealth University-Main Hospital
Richmond, Virginia, 23298
VCU Health at Tappahannock Hospital
Tappahannock, Virginia, 25560
VCU Health-William and Mary
Williamsburg, Virginia, 23185
Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology
Vancouver, Washington, 98686
West Virginia University
Morgantown, West Virginia, 26506
West Virginia
Morgantown, West Virginia, 26506
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
References
- Leitao MM Jr, Bixel KL, Chase DM, Quick A, McCormick C, Black D, Lim PC, Eskander RN, Gotlieb WH, LoCoco S, Martino MA, Walker JL, Copeland LJ, Monk BJ, Randall LM. ROCC/GOG-3043: a randomized controlled trial of robotic versus open surgery for early-stage cervical cancer. Int J Gynecol Cancer. 2025 Jul;35(7):101760. doi: 10.1016/j.ijgc.2025.101760. Epub 2025 Feb 28.(PubMed)
- Boisen M, Guido R. Emerging Treatment Options for Cervical Dysplasia and Early Cervical Cancer. Clin Obstet Gynecol. 2023 Sep 1;66(3):500-515. doi: 10.1097/GRF.0000000000000790. Epub 2023 Jul 25.(PubMed)