A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer (ROCC)

July 29, 2026 updated by: GOG Foundation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20081-250
        • Recruiting
        • Brazilian National Cancer Institute
        • Contact:
        • Principal Investigator:
          • Gustavo Guitmann, PhD
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
    • Sao Paula
      • São Paulo, Sao Paula, Brazil, 04378-500
        • Recruiting
        • Hospital Municipal Vila Santa Catarina
        • Principal Investigator:
          • Renato Moretti-Marques, MD
        • Contact:
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Hospital de Base - Fundacao Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos E Andrade, MD
      • São Paulo, São Paulo, Brazil, 01509001
  • Canada
      • Montreal, Canada, H2X 3E4
    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Dae Yeon Kim, MD
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Chel Hun Choi, PhD
      • Seoul, South Korea, 02843
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
        • Principal Investigator:
          • Jae-Yun Song, MD
      • Seoul, South Korea, 06591
        • Recruiting
        • Seoul St. Mary's Hospital - Catholic University
        • Contact:
        • Principal Investigator:
          • Sung Jong Lee, MD
      • Seoul, South Korea, 07722
        • Recruiting
        • Severance Hospital - Yonsei Cancer Center
        • Contact:
        • Principal Investigator:
          • Sangwun Kim, MD
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Dong Hoon Suh, MD
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:
        • Principal Investigator:
          • Hyun Park, MD
    • Republic of Korea
      • Seoul, Republic of Korea, South Korea, 06273
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • JaeHoon Kim
      • Seoul, Republic of Korea, South Korea, 07722
        • Recruiting
        • Severance Hospital - Yonsei Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sang-wun Kim, MD, PhD
      • Seoul, Republic of Korea, South Korea, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Sohyeon Jeong, MD
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Withdrawn
        • Western Regional Medical Center LLC
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Mihae Song, MD
        • Contact:
      • Encinitas, California, United States, 92024
        • Recruiting
        • University of California San Diego Medical Center
        • Contact:
          • Alexandrea Cronin
        • Contact:
        • Principal Investigator:
          • Pratibha Binder, MD
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope Orange County Lennar Foundation Cancer
        • Principal Investigator:
          • Mihae Song, MD
        • Contact:
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego Medical Center
        • Contact:
          • Alexandrea Cronin
        • Contact:
        • Principal Investigator:
          • Pratibha Binder, MD
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego Moores Cancer Center
        • Principal Investigator:
          • Ramez Eskander, MD
        • Contact:
          • Alexandrea Cronin
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Gynecologic Oncology Clinic
        • Principal Investigator:
          • Dana Chase, MD
        • Contact:
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
        • Principal Investigator:
          • Alberto Mendivil, MD
        • Contact:
      • Newport Beach, California, United States, 92633
        • Recruiting
        • Hoag Gynecologic Oncology
        • Contact:
        • Principal Investigator:
          • Alberto Meddivil, MD
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford Hospital
        • Contact:
        • Principal Investigator:
          • Amer K Karam, MD
      • Palo Alto, California, United States, 94040
        • Withdrawn
        • Palo Alto Medical Foundation
      • San Diego, California, United States, 92103
        • Recruiting
        • University of California San Diego Medical Center
        • Contact:
          • Alexandrea Cronin
        • Contact:
        • Principal Investigator:
          • Pratibha Binder, MD
      • San Francisco, California, United States, 91409
        • Withdrawn
        • California Pacific Medical Center-Research Institute
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope - Upland
        • Principal Investigator:
          • Mihae Song, MD
        • Contact:
      • Vista, California, United States, 92081
        • Recruiting
        • University of California San Diego Medical Center
        • Contact:
          • Alexandrea Cronin
        • Contact:
        • Principal Investigator:
          • Pratibha Binder, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06102
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Hartford HealthCare Cancer Institute at Hartford Hospital
        • Contact:
        • Principal Investigator:
          • Johathan Cosin, MD
      • Manchester, Connecticut, United States, 06042
      • New Britain, Connecticut, United States, 06053
        • Recruiting
        • Harford HealthCare Cancer Institute at the Hospital of Central Connecticut
        • Contact:
        • Principal Investigator:
          • Johathan Cosin, MD
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Ascension Medical Group St. Vincent's Obstetrics and Gynecology
        • Contact:
        • Principal Investigator:
          • Martin Martino, MD
      • Miami, Florida, United States, 33143
      • Miami, Florida, United States, 33176
      • Miami, Florida, United States, 33133
      • Miami, Florida, United States, 33173
      • Miami, Florida, United States, 33140
        • Withdrawn
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, United States, 32806
        • Withdrawn
        • Orlando Health Cancer Center
      • Orlando, Florida, United States, 32806
        • Withdrawn
        • Orlando Health Winnie Palmer Hospital for Woman and Babies
      • Tampa, Florida, United States, 33606
        • Withdrawn
        • Tampa General Hospital
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgian Cancer Center at Augusta University
        • Contact:
        • Principal Investigator:
          • Sharad Ghamande, MD
      • Newnan, Georgia, United States, 30265
        • Withdrawn
        • Southeastern Regional Medical Center LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Withdrawn
        • St. Vincent Hospital and Health Care Center Inc
      • Indianapolis, Indiana, United States, 46260
        • Withdrawn
        • St. Vincent Hospital and Health Care Center, Inc
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Active, not recruiting
        • St. Elizabeth Healthcare
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington
        • Principal Investigator:
          • Hope Cottrill, MD
        • Contact:
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health
        • Principal Investigator:
          • Hope Cottrill, MD
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • LSU Health New Orleans
        • Principal Investigator:
          • Amelia Jernigan, MD
        • Contact:
      • Shreveport, Louisiana, United States, 71118
        • Recruiting
        • Willis-Knighton Physician Network Gynecologic Oncology Associates
        • Principal Investigator:
          • Destin Black, MD
        • Contact:
    • Maine
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology
        • Principal Investigator:
          • Leslie Bradford, MD
        • Contact:
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Withdrawn
        • Baystate Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview University of Minnesota Medical Center-East Bank Hospital
        • Contact:
        • Principal Investigator:
          • Collen Rivard, MD
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • David C. Pratt Center
        • Contact:
        • Principal Investigator:
          • Erica Huelsmann, MD
    • Nevada
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Center of Hope
        • Principal Investigator:
          • Peter Lim, MD
        • Contact:
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering (Basking Ridge)
        • Contact:
        • Principal Investigator:
          • Mario Leitao, MD
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering (Bergen)
        • Contact:
        • Principal Investigator:
          • Mario Leitao, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Active, not recruiting
        • University of New Mexico Comprehensive Cancer Center
    • New York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Northwell Health/South Shore University Hospital
        • Contact:
        • Principal Investigator:
          • Jill Whyte, MD
      • Brightwaters, New York, United States, 11718
        • Recruiting
        • Northwell Health Physician Partners/Gynecological Oncology at Brightwaters
        • Contact:
        • Principal Investigator:
          • Jill Whyte, MD
      • Brooklyn, New York, United States, 11220
        • Recruiting
        • Laura and Issac Perlmutter Cancer Center at NYU Langone
        • Principal Investigator:
          • Whitfield Growdon, MD
        • Contact:
      • Brooklyn, New York, United States, 11220
      • Brooklyn, New York, United States, 11220
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering (Commack)
        • Contact:
        • Principal Investigator:
          • Mario Leitao, MD
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering (Westchester)
        • Contact:
        • Principal Investigator:
          • Mario Leitao, MD
      • Huntington, New York, United States, 11743
        • Recruiting
        • Northwell Health/Huntington Hospital
        • Contact:
        • Principal Investigator:
          • Jill Whyte, MD
      • Middletown, New York, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering (Monmouth)
        • Contact:
        • Principal Investigator:
          • Mario Leitao, MD
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Northwell Health/Long Island Jewish Medical Center
        • Contact:
        • Principal Investigator:
          • Jill Whyte, MD
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • NHPP/Gynecologic Oncology at New Hyde Park
        • Contact:
        • Principal Investigator:
          • Jill Whyte, MD
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street
        • Principal Investigator:
          • Whitfield Growdon, MD
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Issac Perlmutter Cancer Center at NYU Langone
        • Principal Investigator:
          • Whitfield Growdon, MD
        • Contact:
      • New York, New York, United States, 10016
      • New York, New York, United States, 10065
        • Recruiting
        • Josie Robertson Surgery Center
        • Contact:
        • Principal Investigator:
          • Mario Leitao, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (Main Campus)
        • Principal Investigator:
          • Mario Leitao, MD
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • The Blavatnik Family - Chelsea Medical Center at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Kristen P Zeligs, MD
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering (Nassau)
        • Contact:
        • Principal Investigator:
          • Mario Leitao, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Cancer Institute
        • Contact:
          • Kunal Shah
        • Contact:
        • Principal Investigator:
          • Elizabeth Skinner, MD
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
        • Principal Investigator:
          • Emma Rossi, MD
        • Contact:
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Hospital
        • Contact:
        • Principal Investigator:
          • Emma Rossi, MD
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • Novant Health Cancer Institute
        • Contact:
          • Kunal Shah
        • Contact:
        • Principal Investigator:
          • Elizabeth Skinner, MD
      • Kernersville, North Carolina, United States, 27284
        • Recruiting
        • Novant Health Cancer Institute
        • Contact:
          • Kunal Shah
        • Contact:
        • Principal Investigator:
          • Elizabeth Skinner, MD
      • Mount Airy, North Carolina, United States, 27030
        • Recruiting
        • Novant Health Cancer Institute
        • Contact:
          • Kunal Shah
        • Contact:
        • Principal Investigator:
          • Elizabeth Skinner, MD
      • North Wilkesboro, North Carolina, United States, 28659
        • Recruiting
        • Novant Health Cancer Institute
        • Contact:
          • Kunal Shah
        • Contact:
        • Principal Investigator:
          • Elizabeth Skinner, MD
      • Pinehurst, North Carolina, United States, 28374
        • Withdrawn
        • FirstHealth Outpatient Cancer Center
      • Statesville, North Carolina, United States, 28625
        • Recruiting
        • Novant Health Cancer Institute
        • Contact:
          • Kunal Shah
        • Contact:
        • Principal Investigator:
          • Elizabeth Skinner, MD
      • Thomasville, North Carolina, United States, 27360
        • Recruiting
        • Novant Health Cancer Institute
        • Contact:
          • Kunal Shah
        • Contact:
        • Principal Investigator:
          • Elizabeth Skinner, MD
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Cancer Institute
        • Contact:
          • Kunal Shah
        • Contact:
        • Principal Investigator:
          • Elizabeth Skinner, MD
    • Ohio
      • Akron, Ohio, United States, 44304
        • Recruiting
        • Summa Health Jean and Milton Copper Pavilion
        • Contact:
        • Principal Investigator:
          • Clarissa Polen, MD
      • Akron, Ohio, United States, 44304
        • Recruiting
        • Summa Health Jean and Milton Copper Pavillion
        • Contact:
        • Principal Investigator:
          • Clarissa De-Polen, MD
      • Cincinnati, Ohio, United States, 45220
        • Active, not recruiting
        • TriHealth Cancer Institute-Good Samaritan Hospital
      • Cincinnati, Ohio, United States, 45220
        • Active, not recruiting
        • TriHealth Cancer Institute-Thomas Comprehensive Care Center
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University of Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Lindsey Ferguson, MD
      • Columbus, Ohio, United States, 43203
        • Recruiting
        • OSU Wexner Medical Center Hospital East
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Columbus, Ohio, United States, 43203
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care East
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • OSU Wexner Medical Center University Hospital
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • OSU Wexner Medical Center Martha Morehouse Outpatient Care
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care Upper Arlington
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Columbus, Ohio, United States, 43230
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care Gahanna
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care Dublin
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Hilliard, Ohio, United States, 43026
        • Recruiting
        • JamesCare Gynecologic Oncology at Mill Run
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Kettering, Ohio, United States, 45429
      • Lewis Center, Ohio, United States, 43035
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care Lewis Center
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Westerville, Ohio, United States, 43081
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care New Albany
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97210
        • Withdrawn
        • Legacy Good Samaritan Medical Center-Gynecological Oncology Group
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Center Institute Franz Clinic
        • Contact:
        • Principal Investigator:
          • Christopher Darus, MD
      • Tualatin, Oregon, United States, 97062
        • Withdrawn
        • Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Recruiting
        • Abington Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Mitchell Edelson, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Health System, Perelman Center for Advanced Medicine
        • Contact:
        • Principal Investigator:
          • Nawr Latif, MD
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • AHN West Penn Hospital
        • Principal Investigator:
          • Sarah Crafton, MD
        • Contact:
          • Janke Mains- Mason
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Magee - Womens Hospital of UPMC
        • Contact:
        • Principal Investigator:
          • Alexander Olawaiye, MD
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavillion
        • Contact:
        • Principal Investigator:
          • Mitchell Edelson, MD
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Alliance Cancer Specialists, PC
        • Principal Investigator:
          • Mark Shahin, MD
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women's and Infants Hospital of Rhode Island Program in Women's Oncology
        • Principal Investigator:
          • Elizabeth Lokich, MD
        • Contact:
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • Chattanooga's Program In Women's Oncology
        • Principal Investigator:
          • Stephen DePasquale, MD
        • Contact:
      • Germantown, Tennessee, United States, 38119
        • Recruiting
        • The West Clinic, PLLC dba West Cancer Center
        • Contact:
        • Principal Investigator:
          • Todd Tillmanns, MD
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • Texas Oncology-Austin
        • Principal Investigator:
          • Helen Eshed, MD
        • Contact:
      • Bedford, Texas, United States, 76022
      • Bedford, Texas, United States, 76022
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital
        • Contact:
        • Principal Investigator:
          • Elizabeth Stock, MD
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
        • Contact:
        • Principal Investigator:
          • Elizabeth Stock, MD
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology- Baylor Charles A. Sammons Cancer Center
        • Contact:
        • Principal Investigator:
          • Brandon Sawyer, MD
      • Fort Worth, Texas, United States, 76104
      • Fort Worth, Texas, United States, 76104
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology-San Antonio
        • Principal Investigator:
          • Joseph de la Garza, MD
        • Contact:
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology-The Woodlands, Gynecologic Oncology
        • Principal Investigator:
          • Christine Lee, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Leigh Cantrell, MD
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Health System
        • Contact:
        • Principal Investigator:
          • Leslie Randall, MD
      • Henrico, Virginia, United States, 23233
        • Recruiting
        • VCU Health at GreenGate
        • Principal Investigator:
          • Chelsea Salyer, MD
        • Contact:
      • Quinton, Virginia, United States, 23141
        • Recruiting
        • VCU Health Emergency Center at New Kent
        • Contact:
        • Principal Investigator:
          • Chelsea Salyer, MD
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • Chelsea Salyer, MD
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Chelsea Salyer, MD
      • Richmond, Virginia, United States, 23233
        • Recruiting
        • VCU Health Short Pump Pavillion
        • Contact:
        • Principal Investigator:
          • Chelsea Salyer, MD
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University-Main Hospital
        • Contact:
        • Principal Investigator:
          • Chelsea Salyer, MD
      • Tappahannock, Virginia, United States, 25560
        • Active, not recruiting
        • VCU Health at Tappahannock Hospital
      • Williamsburg, Virginia, United States, 23185
        • Recruiting
        • VCU Health-William and Mary
        • Contact:
        • Principal Investigator:
          • Chelsea Salyer, MD
    • Washington
      • Vancouver, Washington, United States, 98686
        • Withdrawn
        • Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
      • Morgantown, West Virginia, United States, 26506
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Clinical Science Center
        • Contact:
        • Principal Investigator:
          • Stephen Rose, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
  2. 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.
  3. Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.

  4. 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:

    1. pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND
    2. 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).

  5. Patient must be age 18 years or older.
  6. Patient must have ECOG performance status 0-1.
  7. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.
  8. Patient must have signed an approved informed consent and authorization permitting the release of personal health information.

Exclusion Criteria:

  1. 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)
  2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
  3. Patient with inability to receive an MRI.
  4. 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).
  5. Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
  6. Patients with a history of prior pelvic or abdominal radiotherapy.
  7. Patients with a prior malignancy < 5 years from enrollment with the exception of non-melanoma skin cancer.
  8. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
  9. Patient compliance and geographic proximity that do not allow adequate follow-up.
  10. Patients with poorly controlled HIV with CD4 counts <500.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open radical or simple hysterectomy
Other: open surgery
open radical or simple hysterectomy
Experimental: Robotic radical or simple hysterectomy
Device: da Vinci
Minimally invasive robotic-assisted radical or simple hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 36 months
3 year disease-free survival
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GOG Foundation

Collaborators

Intuitive Foundation

Investigators

  • Study Chair: Kristin Bixel, MD, Standford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-3043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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