A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
ROCC
A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer (ROCC)
1 other identifier
interventional
840
2 countries
136
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
136 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedStudy Start
First participant enrolled
March 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
December 19, 2024
December 1, 2024
6.4 years
April 1, 2021
December 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Survival
3 year disease-free survival
36 months
Study Arms (2)
Open radical or simple hysterectomy
ACTIVE COMPARATORRobotic radical or simple hysterectomy
EXPERIMENTALInterventions
Minimally invasive robotic-assisted radical or simple hysterectomy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, 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 to randomization are excluded. Patients with definite evidence of vaginal/parametrial involvement on MRI are excluded; if MRI findings are not definitive, then clinical examination must also not reveal parametrial or vaginal extension).
- Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
- Patients with a history of prior pelvic or abdominal radiotherapy.
- Patients with a prior malignancy \< 5 years from enrollment with the exception of non-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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GOG Foundationlead
- Intuitive Foundationcollaborator
Study Sites (136)
Western Regional Medical Center LLC
Goodyear, Arizona, 85338, United States
City of Hope
Duarte, California, 91010, United States
University of California San Diego Medical Center
Encinitas, California, 92024, United States
City of Hope Orange County Lennar Foundation Cancer
Irvine, California, 92618, United States
University of California San Diego Medical Center
La Jolla, California, 92037, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Hoag Gynecologic Oncology
Newport Beach, California, 92633, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Palo Alto Medical Foundation
Palo Alto, California, 94040, United States
Stanford Hospital
Palo Alto, California, 94305, United States
University of California San Diego Medical Center
San Diego, California, 92103, United States
California Pacific Medical Center-Research Institute
San Francisco, California, 91409, United States
City of Hope - Upland
Upland, California, 91786, United States
University of California San Diego Medical Center
Vista, California, 92081, United States
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06106, United States
Hartford Hospital
Hatford, Connecticut, 06102, United States
Hartford Healthcare Medical Group-Manchester
Manchester, Connecticut, 06042, United States
Harford HealthCare Cancer Institute at the Hospital of Central Connecticut
New Britain, Connecticut, 06053, United States
Ascension Medical Group St. Vincent's Obstetrics and Gynecology
Jacksonville, Florida, 32204, United States
Mercy Hospital
Miami, Florida, 33133, United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140, United States
South Miami Hospital
Miami, Florida, 33143, United States
South Miami Hospital
Miami, Florida, 33143, United States
Mercy Hospital
Miami, Florida, 33173, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Orlando Health Cancer Center
Orlando, Florida, 32806, United States
Orlando Health Winnie Palmer Hospital for Woman and Babies
Orlando, Florida, 32806, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Georgian Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Southeastern Regional Medical Center LLC
Newnan, Georgia, 30265, United States
St. Vincent Hospital and Health Care Center Inc
Indianapolis, Indiana, 46260, United States
St. Vincent Hospital and Health Care Center, Inc
Indianapolis, Indiana, 46260, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Baptist Health
Lexington, Kentucky, 40503, United States
LSU Health New Orleans
New Orleans, Louisiana, 70112, United States
Willis-Knighton Physician Network Gynecologic Oncology Associates
Shreveport, Louisiana, 71118, United States
Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology
Scarborough, Maine, 04074, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404, United States
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota, 55455, United States
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota, 55455, United States
David C. Pratt Center
St Louis, Missouri, 63141, United States
Center of Hope
Reno, Nevada, 89511, United States
Memorial Sloan Kettering (Basking Ridge)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering (Bergen)
Montvale, New Jersey, 07645, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131, United States
Northwell Health/South Shore University Hospital
Bay Shore, New York, 11706, United States
Northwell Health Physician Partners/Gynecological Oncology at Brightwaters
Brightwaters, New York, 11718, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
Brooklyn, New York, 11220, United States
NYU Langone Ambulatory Care Bay Ridge
Brooklyn, New York, 11220, United States
NYU Langone Hospital-Brooklym
Brooklyn, New York, 11220, United States
Memorial Sloan Kettering (Commack)
Commack, New York, 11725, United States
Memorial Sloan Kettering (Westchester)
Harrison, New York, 10604, United States
Northwell Health/Huntington Hospital
Huntington, New York, 11743, United States
Memorial Sloan Kettering (Monmouth)
Middletown, New York, 07748, United States
Northwell Health/Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
NHPP/Gynecologic Oncology at New Hyde Park
New Hyde Park, New York, 11042, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street
New York, New York, 10016, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York, 10016, United States
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York, 10029, United States
Josie Robertson Surgery Center
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center (Main Campus)
New York, New York, 10065, United States
Memorial Sloan Kettering (Nassau)
Uniondale, New York, 11553, United States
Novant Health Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke University Hospital
Durham, North Carolina, 27705, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Novant Health Cancer Institute
Greensboro, North Carolina, 27403, United States
Novant Health Cancer Institute
Kernersville, North Carolina, 27284, United States
Novant Health Cancer Institute
Mount Airy, North Carolina, 27030, United States
Novant Health Cancer Institute
North Wilkesboro, North Carolina, 28659, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
Novant Health Cancer Institute
Statesville, North Carolina, 28625, United States
Novant Health Cancer Institute
Thomasville, North Carolina, 27360, United States
Novant Health Cancer Institute
Winston-Salem, North Carolina, 27103, United States
Summa Health Jean and Milton Copper Pavilion
Akron, Ohio, 44304, United States
Summa Health Jean and Milton Copper Pavillion
Akron, Ohio, 44304, United States
TriHealth Cancer Institute-Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
TriHealth Cancer Institute-Thomas Comprehensive Care Center
Cincinnati, Ohio, 45220, United States
University of Cleveland Medical Center
Cleveland, Ohio, 44106, United States
OSU Wexner Medical Center Hospital East
Columbus, Ohio, 43203, United States
OSU Wexner Medical Center Outpatient Care East
Columbus, Ohio, 43203, United States
James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
OSU Wexner Medical Center University Hospital
Columbus, Ohio, 43210, United States
OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212, United States
OSU Wexner Medical Center Martha Morehouse Outpatient Care
Columbus, Ohio, 43221, United States
OSU Wexner Medical Center Outpatient Care Upper Arlington
Columbus, Ohio, 43221, United States
OSU Wexner Medical Center Outpatient Care Gahanna
Columbus, Ohio, 43230, United States
OSU Wexner Medical Center Outpatient Care Dublin
Dublin, Ohio, 43016, United States
JamesCare Gynecologic Oncology at Mill Run
Hilliard, Ohio, 43026, United States
Kettering Health Cancer Center
Kettering, Ohio, 45429, United States
OSU Wexner Medical Center Outpatient Care Lewis Center
Lewis Center, Ohio, 43035, United States
OSU Wexner Medical Center Outpatient Care New Albany
Westerville, Ohio, 43081, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Legacy Good Samaritan Medical Center-Gynecological Oncology Group
Portland, Oregon, 97210, United States
Providence Center Institute Franz Clinic
Portland, Oregon, 97213, United States
Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology
Tualatin, Oregon, 97062, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Magee - Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Asplundh Cancer Pavillion
Willow Grove, Pennsylvania, 19090, United States
Women's and Infants Hospital of Rhode Island Program in Women's Oncology
Providence, Rhode Island, 02905, United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, 37403, United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38119, United States
Texas Oncology-Austin
Austin, Texas, 78758, United States
Texas Oncology- GYN ONC DFWW
Bedford, Texas, 76022, United States
Texas Oncology-DFWW
Bedford, Texas, 76022, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center-Simmons Cancer Center
Dallas, Texas, 75390, United States
University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital
Dallas, Texas, 75390, United States
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
Dallas, Texas, 75390, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Oncology-GYN ONC DFWW
Fort Worth, Texas, 76104, United States
Texas Oncology
Fort Worth, Texas, 76104, United States
Texas Oncology-San Antonio
San Antonio, Texas, 78240, United States
Texas Oncology-The Woodlands, Gynecologic Oncology
The Woodlands, Texas, 77380, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
VCU Health at GreenGate
Henrico, Virginia, 23233, United States
VCU Health Emergency Center at New Kent
Quinton, Virginia, 23141, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23219, United States
VCU Health Short Pump Pavillion
Richmond, Virginia, 23233, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
Virginia Commonwealth University-Main Hospital
Richmond, Virginia, 23298, United States
VCU Health at Tappahannock Hospital
Tappahannock, Virginia, 25560, United States
VCU Health-William and Mary
Williamsburg, Virginia, 23185, United States
Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology
Vancouver, Washington, 98686, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
West Virginia
Morgantown, West Virginia, 26506, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792, United States
McGill University Health Centre-Glen Site
Montreal, Quebec, H4A 3J1, Canada
Centre Hospitalier De L'Universite De Montreal
Montreal, H2X 3E4, Canada
Related Publications (2)
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.
PMID: 40188007DERIVEDBoisen 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.
PMID: 37650664DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kristin Bixel, MD
Standford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 5, 2021
Study Start
March 22, 2022
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2029
Last Updated
December 19, 2024
Record last verified: 2024-12