AzTrials
AzTrials

Cervical CancerROCCNCT04831580

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

A study testing da Vinci and open surgery in people with Cervical Cancer, run by GOG Foundation at 156 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
da Vinci and open surgery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
156 sitesin 4 countries
Study dates
22 Mar 2022to Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

156 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Sarin Chhab contact

215-854-0770

schhab@gog.org

Shanon Matkin contact

801-661-1584

smatkin@gog.org

156 sites in 4 countries

United States137 sites, 117 recruiting

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

    Ashley Douglas, ashley.douglas@jefferson.edu

    Mitchell Edelson, MD

    Recruiting

  • Summa Health Jean and Milton Copper Pavilion

    Akron, Ohio, 44304

    Danielle McCutcheon, mccutcheond@summahealth.org

    Clarissa Polen, MD

    Recruiting

  • Summa Health Jean and Milton Copper Pavillion

    Akron, Ohio, 44304

    Danielle McCutcheon, mamccutcheond@summahealth.org

    Clarissa De-Polen, MD

    Recruiting

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

    Active, not recruiting

  • Georgian Cancer Center at Augusta University

    Augusta, Georgia, 30912

    Angela Goebel, agoebel@augusta.edu

    Sharad Ghamande, MD

    Recruiting

  • Texas Oncology-Austin

    Austin, Texas, 78758

    Kelli Watkins, kelli.watkins@mckesson.com

    Helen Eshed, MD

    Recruiting

  • Memorial Sloan Kettering (Basking Ridge)

    Basking Ridge, New Jersey, 07920

    Josie Anderson, andersj@mskcc.org

    Mario Leitao, MD

    Recruiting

  • Northwell Health/South Shore University Hospital

    Bay Shore, New York, 11706

    Batool Mubashar, mailto:bmubashar@northwell.edu

    Jill Whyte, MD

    Recruiting

  • Texas Oncology- GYN ONC DFWW

    Bedford, Texas, 76022

    Nori Sullivan, mailto:nori.sullivan@usoncology.com

    Noelle Cloven, MD

    Recruiting

  • Texas Oncology-DFWW

    Bedford, Texas, 76022

    Sarah Wade, mailto:Sarah.Wade@usoncology.com

    Mark Messing, MD

    Recruiting

  • Northwell Health Physician Partners/Gynecological Oncology at Brightwaters

    Brightwaters, New York, 11718

    Batool Mubashar, mailto:bmubashar@northwell.edu

    Jill Whyte, MD

    Recruiting

  • Laura and Issac Perlmutter Cancer Center at NYU Langone

    Brooklyn, New York, 11220

    Kathryn Allen, mailto:Kathryn.Allen@nyulangone.org

    Whitfield Growdon, MD

    Recruiting

  • NYU Langone Ambulatory Care Bay Ridge

    Brooklyn, New York, 11220

    Kathryn Allen, mailto:Kathryn.Allen@nyulangone.org

    Whitfield Growdon, MD

    Recruiting

  • NYU Langone Hospital-Brooklym

    Brooklyn, New York, 11220

    Kathryn Allen, mailto:Kathryn.Allen@nyulangone.org

    Whitfield Growdon, MD

    Recruiting

  • Novant Health Cancer Institute

    Charlotte, North Carolina, 28204

    Kunal Shah

    kashah@novanthealth.org

    Recruiting

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22903

    Rachel Lacy, mrmc9p@hscmail.mcc.virginia.edu

    Leigh Cantrell, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22903

    Rachel Lacy, rmc9p@hscmail.mcc.virginia.edu

    Leigh Cantrell, MD

    Recruiting

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

    Kimberly Donelson, Kimberly.Donelson@erlanger.org

    Stephen Depasquale, MD

    Recruiting

  • TriHealth Cancer Institute-Good Samaritan Hospital

    Cincinnati, Ohio, 45220

    Active, not recruiting

  • TriHealth Cancer Institute-Thomas Comprehensive Care Center

    Cincinnati, Ohio, 45220

    Active, not recruiting

  • University of Cleveland Medical Center

    Cleveland, Ohio, 44106

    Lauren Patrick, Lauren.Patrick@uhhospitals.org

    Lindsey Ferguson, MD

    Recruiting

  • OSU Wexner Medical Center Hospital East

    Columbus, Ohio, 43203

    Callan Myerscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • OSU Wexner Medical Center Outpatient Care East

    Columbus, Ohio, 43203

    Callan Myserscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Callan Myercough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • OSU Wexner Medical Center University Hospital

    Columbus, Ohio, 43210

    Callan Myerscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212

    Callan Myerscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • OSU Wexner Medical Center Martha Morehouse Outpatient Care

    Columbus, Ohio, 43221

    Callan Myerscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • OSU Wexner Medical Center Outpatient Care Upper Arlington

    Columbus, Ohio, 43221

    Callan Myerscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • OSU Wexner Medical Center Outpatient Care Gahanna

    Columbus, Ohio, 43230

    Callan Myerscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • Memorial Sloan Kettering (Commack)

    Commack, New York, 11725

    Josie Anderson, andersj@mskcc.org

    Mario Leitao, MD

    Recruiting

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

    Christine Terraciano, 214-370-1000, christine.terraciano@usoncology.com

    Brandon Sawyer, MD

    Recruiting

  • University of Texas Southwestern Medical Center-Simmons Cancer Center

    Dallas, Texas, 75390

    Annette Paulsen, mailto:Annette.Paulsen@UTSouthwestern.edu

    Elizabeth Stock, MD

    Recruiting

  • University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital

    Dallas, Texas, 75390

    Annette Paulsen, Annette.Paulsen@UTSouthwestern.edu

    Elizabeth Stock, MD

    Recruiting

  • University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

    Dallas, Texas, 75390

    Annette Paulsen, Annette.Paulsen@UTSouthwestern.edu

    Elizabeth Stock, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Annette Paulsen, mailto:Annette.Paulsen@UTSouthwestern.edu

    Elizabeth Stock, MD

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Raechelle Tinsley, RTinsley@coh.org

    Mihae Song, MD

    Recruiting

  • OSU Wexner Medical Center Outpatient Care Dublin

    Dublin, Ohio, 43016

    Callan Myerscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • Duke University Hospital

    Durham, North Carolina, 27705

    Taylor Hayes, taylor.hayes@duke.edu

    Emma Rossi, MD

    Recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Taylor Hayes, taylor.hayes@duke.edu

    Emma Rossi, MD

    Recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Lauren March, lauren.march@duke.edu

    Emma Rossi, MD

    Recruiting

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

    Active, not recruiting

  • University of California San Diego Medical Center

    Encinitas, California, 92024

    Alexandrea Cronin

    aocronin@health.ucsd.edu

    Recruiting

  • Inova Health System

    Fairfax, Virginia, 22031

    Takada Harris, takada.harris@inova.org

    Leslie Randall, MD

    Recruiting

  • Texas Oncology-GYN ONC DFWW

    Fort Worth, Texas, 76104

    Nori Sullivan, mailto:nori.sullivan@usoncology.com

    Noelle Cloven, MD

    Recruiting

  • Texas Oncology

    Fort Worth, Texas, 76104

    Nori Sullivan, mailto:nori.sullivan@usoncology.com

    Noelle Cloven, MD

    Recruiting

  • The West Clinic, PLLC dba West Cancer Center

    Germantown, Tennessee, 38119

    Joslyn Walker, 901-683-0055, jowalker@westclinic.com

    Todd Tillmanns, MD

    Recruiting

  • Western Regional Medical Center LLC

    Goodyear, Arizona, 85338

    Withdrawn

  • Novant Health Cancer Institute

    Greensboro, North Carolina, 27403

    Kunal Shah

    kashah@novanthealth.org

    Recruiting

  • Memorial Sloan Kettering (Westchester)

    Harrison, New York, 10604

    Josie Anderson, andersj@mskcc.org

    Mario Leitao, MD

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Siobhan Reilly, mailto:siobhan.reilly@hhchealth.org

    Johathan Cosin, MD

    Recruiting

  • Hartford Healthcare Cancer Institute at Hartford Hospital

    Hartford, Connecticut, 06106

    Siobhan Reilly, mailto:siobhan.reilly@hhchealth.org

    Johathan Cosin, MD

    Recruiting

  • VCU Health at GreenGate

    Henrico, Virginia, 23233

    Sonya Washington, slwashington@vcu.edu

    Chelsea Salyer, MD

    Recruiting

  • JamesCare Gynecologic Oncology at Mill Run

    Hilliard, Ohio, 43026

    Callan Myerscough, macallan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • Northwell Health/Huntington Hospital

    Huntington, New York, 11743

    Batool Mubashar, mailto:bmubashar@northwell.edu

    Jill Whyte, MD

    Recruiting

  • St. Vincent Hospital and Health Care Center Inc

    Indianapolis, Indiana, 46260

    Withdrawn

  • St. Vincent Hospital and Health Care Center, Inc

    Indianapolis, Indiana, 46260

    Withdrawn

  • City of Hope Orange County Lennar Foundation Cancer

    Irvine, California, 92618

    Raechelle Tinsley, rtinsley@coh.org

    Mihae Song, MD

    Recruiting

  • Ascension Medical Group St. Vincent's Obstetrics and Gynecology

    Jacksonville, Florida, 32204

    Nicole Antenucci, nicole.antenucci@ascension.org

    Martin Martino, MD

    Recruiting

  • Novant Health Cancer Institute

    Kernersville, North Carolina, 27284

    Kunal Shah

    kashah@novanthealth.org

    Recruiting

  • Kettering Health Cancer Center

    Kettering, Ohio, 45429

    Julie Carstens, julie.carstens@ketteringhealth.org

    Thomas Reid, MD

    Recruiting

  • University of California San Diego Medical Center

    La Jolla, California, 92037

    Alexandrea Cronin

    aocronin@health.ucsd.edu

    Recruiting

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

    Alexandrea Cronin

    aocronin@health.ucsd.edu

    Recruiting

  • OSU Wexner Medical Center Outpatient Care Lewis Center

    Lewis Center, Ohio, 43035

    Callan Myerscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

    Lauren Higgins, lauren.higgins@bhsi.com

    Hope Cottrill, MD

    Recruiting

  • Baptist Health

    Lexington, Kentucky, 40503

    Lauren Higgins, lauren.higgins@bhsi.com

    Hope Cottrill, MD

    Recruiting

  • UCLA Gynecologic Oncology Clinic

    Los Angeles, California, 90095

    Dana Chase, MD, dmchase@mednet.ucla.edu

    Dana Chase, MD

    Recruiting

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

    Claire Kostechka, kostechka@wisc.edu

    Stephen Rose, MD

    Recruiting

  • Hartford Healthcare Medical Group-Manchester

    Manchester, Connecticut, 06042

    Siobhan Reilly, mailto:siobhan.reilly@hhchealth.org

    Johathan Cosin, MD

    Recruiting

  • Mercy Hospital

    Miami, Florida, 33133

    Jennifer Mosley, Jennifer.mosley@hcahealthcare.com

    Ricardo Estape, MD

    Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami, Florida, 33140

    Withdrawn

  • South Miami Hospital

    Miami, Florida, 33143

    Jacqueline Lebron, jacquelile@baptisthealth.net

    John P Diaz, MD

    Recruiting

  • South Miami Hospital

    Miami, Florida, 33143

    Stephany Fuentes Angulo, Stephany.FuentesAngulo@baptisthealth.net

    John Diaz, MD

    Recruiting

  • Mercy Hospital

    Miami, Florida, 33173

    Jennifer Mosley, Jennifer.mosley@hcahealthcare.com

    Ricardo Estape, MD

    Recruiting

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

    Jacqueline Lebron, jacquelile@baptisthealth.net

    John P Diaz, MD

    Recruiting

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

    Stephany Fuentes Angulo, Stephany.FuentesAngulo@baptisthealth.net

    John Diaz, MD

    Recruiting

  • Memorial Sloan Kettering (Monmouth)

    Middletown, New York, 07748

    Josie Anderson, andersj@mskcc.org

    Mario Leitao, MD

    Recruiting

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

    Jessica Thomes-Pepin, jessica.thomespepin@usoncology.com

    Jessica Thomes-Pepin, MD

    Recruiting

  • M Health Fairview University of Minnesota Medical Center-East Bank Hospital

    Minneapolis, Minnesota, 55455

    Erin Zielinksi, eezielin@umn.edu

    Colleen Rivard, MD

    Recruiting

  • M Health Fairview University of Minnesota Medical Center-East Bank Hospital

    Minneapolis, Minnesota, 55455

    Erin Zielinksi, eezielin@umn.edu

    Collen Rivard, MD

    Recruiting

  • Memorial Sloan Kettering (Bergen)

    Montvale, New Jersey, 07645

    Josie Anderson, andersj@mskcc.org

    Mario Leitao, MD

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Christina Martinelli, mailto:christina.martinelli@hsc.wvu.edu

    Krista Phaendler, MD

    Recruiting

  • West Virginia

    Morgantown, West Virginia, 26506

    Christina Martinelli, mailto:christina.martinelli@hsc.wvu.edu

    Krista Pfaendler, MD

    Recruiting

  • Novant Health Cancer Institute

    Mount Airy, North Carolina, 27030

    Kunal Shah

    kashah@novanthealth.org

    Recruiting

  • Harford HealthCare Cancer Institute at the Hospital of Central Connecticut

    New Britain, Connecticut, 06053

    Siobhan Reilly, mailto:siobhan.reilly@hhchealth.org

    Johathan Cosin, MD

    Recruiting

  • Northwell Health/Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

    Batool Mubashar, mailto:bmubashar@northwell.edu

    Jill Whyte, MD

    Recruiting

  • NHPP/Gynecologic Oncology at New Hyde Park

    New Hyde Park, New York, 11042

    Batool Mubashar, mailto:bmubashar@northwell.edu

    Jill Whyte, MD

    Recruiting

  • LSU Health New Orleans

    New Orleans, Louisiana, 70112

    Dina Brackman, dbrack@lsuhsc.edu

    Amelia Jernigan, MD

    Recruiting

  • Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street

    New York, New York, 10016

    Kathryn Allen, mailto:Kathryn.Allen@nyulangone.org

    Whitfield Growdon, MD

    Recruiting

  • Laura and Issac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Kathryn Allen, mailto:Kathryn.Allen@nyulangone.org

    Whitfield Growdon, MD

    Recruiting

  • NYU Langone Medical Center (Tisch Hospital)

    New York, New York, 10016

    Kathryn Allen, mailto:Kathryn.Allen@nyulangone.org

    Whitfield Growdon, MD

    Recruiting

  • The Blavatnik Family - Chelsea Medical Center at Mount Sinai

    New York, New York, 10029

    Neha Kumarley, 212-824-7859, Kuneha.kumarley@mssm.edu

    Kristen P Zeligs, MD

    Recruiting

  • Josie Robertson Surgery Center

    New York, New York, 10065

    Josie Anderson, andersj@mskcc.org

    Mario Leitao, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center (Main Campus)

    New York, New York, 10065

    Josie Anderson, mailto:andersj@mskcc.org

    Mario Leitao, MD

    Recruiting

  • Southeastern Regional Medical Center LLC

    Newnan, Georgia, 30265

    Withdrawn

  • Hoag Gynecologic Oncology

    Newport Beach, California, 92633

    Ana Navarrete, ana.navarrete@hoag.org

    Alberto Meddivil, MD

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Ana Navarrete, ana.navarrete@hoag.org

    Alberto Mendivil, MD

    Recruiting

  • Novant Health Cancer Institute

    North Wilkesboro, North Carolina, 28659

    Kunal Shah

    kashah@novanthealth.org

    Recruiting

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Morgan Hays, mailto:morgan-hays@ouhsc.edu

    Joan Walker, MD

    Recruiting

  • Orlando Health Cancer Center

    Orlando, Florida, 32806

    Withdrawn

  • Orlando Health Winnie Palmer Hospital for Woman and Babies

    Orlando, Florida, 32806

    Withdrawn

  • Palo Alto Medical Foundation

    Palo Alto, California, 94040

    Withdrawn

  • Stanford Hospital

    Palo Alto, California, 94305

    Samya Konda, skonda@stanford.edu

    Amer K Karam, MD

    Recruiting

  • University of Pennsylvania Health System, Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

    Christine Yang, christine.yang@pennmedicine.upenn.edu

    Nawr Latif, MD

    Recruiting

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

    Withdrawn

  • Magee - Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

    Jessica Yauch, yauchj@upmc.edu

    Alexander Olawaiye, MD

    Recruiting

  • AHN West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Janke Mains- Mason

    janke.mainsmason@ahn.org

    Recruiting

  • Legacy Good Samaritan Medical Center-Gynecological Oncology Group

    Portland, Oregon, 97210

    Withdrawn

  • Providence Center Institute Franz Clinic

    Portland, Oregon, 97213

    Nora Auston, Nora.Auston@providence.org

    Christopher Darus, MD

    Recruiting

  • Women's and Infants Hospital of Rhode Island Program in Women's Oncology

    Providence, Rhode Island, 02905

    Ann John, ajohn@wihri.org

    Elizabeth Lokich, MD

    Recruiting

  • VCU Health Emergency Center at New Kent

    Quinton, Virginia, 23141

    Sonya Washington, mailto:slwashington@vcu.edu

    Chelsea Salyer, MD

    Recruiting

  • Center of Hope

    Reno, Nevada, 89511

    Shannon White Pierpoint, spierpoint@cohreno.com

    Peter Lim, MD

    Recruiting

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23219

    Sonya Washington, mailto:slwashington@vcu.edu

    Chelsea Salyer, MD

    Recruiting

  • VCU Health Short Pump Pavillion

    Richmond, Virginia, 23233

    Sonya Washington, mailto:slwashington@vcu.edu

    Chelsea Salyer, MD

    Recruiting

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

    Sonya Washington, mailto:slwashington@vcu.edu

    Chelsea Salyer, MD

    Recruiting

  • Virginia Commonwealth University-Main Hospital

    Richmond, Virginia, 23298

    Sonya Washington, mailto:slwashington@vcu.edu

    Chelsea Salyer, MD

    Recruiting

  • Texas Oncology-San Antonio

    San Antonio, Texas, 78240

    Riquanda Walker, Riquanda.Walker@McKesson.com

    Joseph de la Garza, MD

    Recruiting

  • University of California San Diego Medical Center

    San Diego, California, 92103

    Alexandrea Cronin

    aocronin@health.ucsd.edu

    Recruiting

  • California Pacific Medical Center-Research Institute

    San Francisco, California, 91409

    Withdrawn

  • Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology

    Scarborough, Maine, 04074

    Robin Donovan, donovr@mmc.org

    Leslie Bradford, MD

    Recruiting

  • Willis-Knighton Physician Network Gynecologic Oncology Associates

    Shreveport, Louisiana, 71118

    Carrie Key, RN, ckay@wkhs.com

    Destin Black, MD

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Withdrawn

  • David C. Pratt Center

    St Louis, Missouri, 63141

    Crystal Tindall, crystal.tindall@mercy.net

    Erica Huelsmann, MD

    Recruiting

  • Novant Health Cancer Institute

    Statesville, North Carolina, 28625

    Kunal Shah

    kashah@novanthealth.org

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Withdrawn

  • VCU Health at Tappahannock Hospital

    Tappahannock, Virginia, 25560

    Active, not recruiting

  • Texas Oncology-The Woodlands, Gynecologic Oncology

    The Woodlands, Texas, 77380

    Kelli Watkins, Kelli.Watkins@mckesson.com

    Christine Lee, MD

    Recruiting

  • Novant Health Cancer Institute

    Thomasville, North Carolina, 27360

    Kunal Shah

    kashah@novanthealth.org

    Recruiting

  • Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology

    Tualatin, Oregon, 97062

    Withdrawn

  • Memorial Sloan Kettering (Nassau)

    Uniondale, New York, 11553

    Josie Anderson, andersj@mskcc.org

    Mario Leitao, MD

    Recruiting

  • City of Hope - Upland

    Upland, California, 91786

    Raechelle Tinsley, rtinsley@coh.org

    Mihae Song, MD

    Recruiting

  • Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology

    Vancouver, Washington, 98686

    Withdrawn

  • University of California San Diego Medical Center

    Vista, California, 92081

    Alexandrea Cronin

    aocronin@health.ucsd.edu

    Recruiting

  • OSU Wexner Medical Center Outpatient Care New Albany

    Westerville, Ohio, 43081

    Callan Myerscough, callan.myerscough@osumc.edu

    Floor Backes, MD

    Recruiting

  • VCU Health-William and Mary

    Williamsburg, Virginia, 23185

    Sonya Washington, mailto:slwashington@vcu.edu

    Chelsea Salyer, MD

    Recruiting

  • Asplundh Cancer Pavillion

    Willow Grove, Pennsylvania, 19090

    Ashley Douglas, ashley.douglas@jefferson.edu

    Mitchell Edelson, MD

    Recruiting

  • Novant Health Cancer Institute

    Winston-Salem, North Carolina, 27103

    Kunal Shah

    kashah@novanthealth.org

    Recruiting

  • Alliance Cancer Specialists, PC

    Wynnewood, Pennsylvania, 19096

    Mark Shahin, MD, mark.shahin@usoncology.com

    Mark Shahin, MD

    Recruiting

Other trials in United States

South Korea10 sites, 10 recruiting

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

    Hyun Park, MD, p06162006@cha.ac.kr

    Hyun Park, MD

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Dong Hoon Suh, MD, sdhwcj@naver.com

    Dong Hoon Suh, MD

    Recruiting

  • Gangnam Severance Hospital

    Seoul, Republic of Korea, 06273

    JaeHoon Kim, jaehoonkim@yuhs.ac

    HyunJin Lee, pistis@yuhs.ac

    Recruiting

  • Severance Hospital - Yonsei Cancer Center

    Seoul, Republic of Korea, 07722

    Ji Won, Woo, te05028@yuhs.ac

    Sang-wun Kim, MD, PhD, san1@yuhs.ac

    Recruiting

  • Korea University Guro Hospital

    Seoul, Republic of Korea, 08308

    Sohyeon Jeong, MD, shj9918@gmail.com

    Sohyeon Jeong, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul, 02843

    Jae-Yun Song, MD, sjyuni105@gmail.com

    Jae-Yun Song, MD

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Dae Yeon Kim, MD, kdyog@amc.seoul.kr

    Dae Yeon Kim, MD

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Chel Hun Choi, PhD, chelhun.choi@samsung.com

    Chel Hun Choi, PhD

    Recruiting

  • Seoul St. Mary's Hospital - Catholic University

    Seoul, 06591

    Sung Jong Lee, MD, orlando@catholic.ac.kr

    Sung Jong Lee, MD

    Recruiting

  • Severance Hospital - Yonsei Cancer Center

    Seoul, 07722

    Sangwun Kim, MD, san1@yuhs.ac

    Sangwun Kim, MD

    Recruiting

Other trials in South Korea

Brazil6 sites, 6 recruiting

  • Barretos Cancer Hospital

    Barretos, São Paulo, 14784-400

    Daniela Augustin, daniela.augustin@lacogcancerresearch.org

    Ricardo dos Reis, PhD

    Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

    Erik M Coelho, erik.coelho@lacog.group

    Audrey Tsunoda, MD, atsunoda@gmail.com

    Recruiting

  • Brazilian National Cancer Institute

    Rio de Janeiro, 20081-250

    Gustavo Guitmann, PhD, Guitmann@clinicagincol.com.br

    Gustavo Guitmann, PhD

    Recruiting

  • Hospital de Base - Fundacao Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

    Carlos E Andrade, MD, mdcarlosandrade@gmail.com

    Erik Coelho, erik.coelho@lacog.group

    Recruiting

  • Hospital Municipal Vila Santa Catarina

    São Paulo, Sao Paula, 04378-500

    Renato Moretti-Marques, MD, renato.moretti@einstein.br

    Renato Moretti-Marques, MD

    Recruiting

  • A.C.Camargo Cancer Center

    São Paulo, São Paulo, 01509001

    Daniela Augustin, daniela.augustin@lacogcancerresearch.org

    Glauco Baiocchi Neto, PhD

    Recruiting

Other trials in Brazil

Canada3 sites, 3 recruiting

  • McGill University Health Centre-Glen Site

    Montreal, Quebec, H4A 3J1

    Phuong-Nam Nguyen, mailto:phuong-nam.nguyen@mail.mcgill.ca

    Xing Zeng, MD

    Recruiting

  • Centre Hospitalier De L'Universite De Montreal

    Montreal, H2X 3E4

    Mathilde Duplaix, mathilde.duplaix.chum@ssss.gouv.qc.ca

    Vanessa Samouelian, MD

    Recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G2M9

    Vanessa Ballin, Vanessa.Ballin@uhn.ca

    Sarah Ferguson, MD, sarah.ferguson@uhn.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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)

Conditions
Cervical Cancer
Being tested
da Vinci, open surgery
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • da VinciDevice

    Minimally invasive robotic-assisted radical or simple hysterectomy

  • open surgeryOther

    open radical or simple hysterectomy

Study groups in NCT04831580
Study groupRoleWhat they receive
Open radical or simple hysterectomyActive comparatorNot described
Receives: Other: open surgery
Robotic radical or simple hysterectomyExperimentalNot described
Receives: Device: da Vinci

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    3 year disease-free survival

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start22 Mar 2022
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
840 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04831580
Sponsor's protocol ID
GOG-3043
Acronym
ROCC
Status last verified
Jul 2026
First submitted
1 Apr 2021
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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 40188007

  • 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 37650664

Questions about this trial

What is this clinical trial studying?

A study testing da Vinci and open surgery in people with Cervical Cancer, run by GOG Foundation at 156 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, South Korea, Brazil, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarin Chhab (215-854-0770, schhab@gog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04831580, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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