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Robot or scalpel? a Head-to-Head trial for cervical cancer surgery

NCT ID NCT04831580

Disease control Sponsor: GOG Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial compares two surgical approaches for early-stage cervical cancer: robotic-assisted surgery using the da Vinci system versus traditional open surgery. Researchers are asking whether the minimally invasive robotic method can match or improve upon open surgery in terms of cancer-free survival three years after treatment. The study enrolls 840 women with specific early-stage cervical cancer types and stages, aiming to clarify the best surgical option for long-term outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
robotic-assisted surgery using the da Vinci system
What this could lead to
If robotic surgery proves as effective as open surgery, it could offer a less invasive option with faster recovery for early-stage cervical cancer patients.
What could go wrong
This is a large trial, but robotic surgery may still carry higher risks of certain complications or lower survival rates compared to the traditional open approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 840 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    136 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.C.Camargo Cancer Center

    RECRUITING

    São Paulo, São Paulo, 01509001, Brazil

  • AHN West Penn Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Abington Memorial Hospital

    RECRUITING

    Abington, Pennsylvania, 19001, United States

  • Alliance Cancer Specialists, PC

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

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

    RECRUITING

    Jacksonville, Florida, 32204, United States

  • Asplundh Cancer Pavillion

    RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

  • Baptist Health

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Baptist Health Lexington

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Barretos Cancer Hospital

    RECRUITING

    Barretos, São Paulo, 14784-400, Brazil

  • Baystate Medical Center

    WITHDRAWN

    Springfield, Massachusetts, 01199, United States

  • Brazilian National Cancer Institute

    RECRUITING

    Rio de Janeiro, 20081-250, Brazil

  • CHA Bundang Medical Center

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • California Pacific Medical Center-Research Institute

    WITHDRAWN

    San Francisco, California, 91409, United States

  • Center of Hope

    RECRUITING

    Reno, Nevada, 89511, United States

  • Centre Hospitalier De L'Universite De Montreal

    RECRUITING

    Montreal, H2X 3E4, Canada

  • Chattanooga's Program in Women's Oncology

    RECRUITING

    Chattanooga, Tennessee, 37403, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope - Upland

    RECRUITING

    Upland, California, 91786, United States

  • City of Hope Orange County Lennar Foundation Cancer

    RECRUITING

    Irvine, California, 92618, United States

  • David C. Pratt Center

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27705, United States

  • FirstHealth Outpatient Cancer Center

    WITHDRAWN

    Pinehurst, North Carolina, 28374, United States

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, Republic of Korea, 06273, South Korea

  • Georgian Cancer Center at Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Harford HealthCare Cancer Institute at the Hospital of Central Connecticut

    RECRUITING

    New Britain, Connecticut, 06053, United States

  • Hartford Healthcare Cancer Institute at Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Hartford Healthcare Medical Group-Manchester

    RECRUITING

    Manchester, Connecticut, 06042, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Hoag Gynecologic Oncology

    RECRUITING

    Newport Beach, California, 92633, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hospital Erasto Gaertner

    RECRUITING

    Curitiba, Paraná, 81520-060, Brazil

  • Hospital Municipal Vila Santa Catarina

    RECRUITING

    São Paulo, Sao Paula, 04378-500, Brazil

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

    RECRUITING

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

  • Inova Health System

    RECRUITING

    Fairfax, Virginia, 22031, United States

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

    RECRUITING

    Columbus, Ohio, 43210, United States

  • JamesCare Gynecologic Oncology at Mill Run

    RECRUITING

    Hilliard, Ohio, 43026, United States

  • Josie Robertson Surgery Center

    RECRUITING

    New York, New York, 10065, United States

  • Kettering Health Cancer Center

    RECRUITING

    Kettering, Ohio, 45429, United States

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 02843, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, Republic of Korea, 08308, South Korea

  • LSU Health New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Laura and Issac Perlmutter Cancer Center at NYU Langone

    RECRUITING

    Brooklyn, New York, 11220, United States

  • Laura and Issac Perlmutter Cancer Center at NYU Langone

    RECRUITING

    New York, New York, 10016, United States

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

    RECRUITING

    New York, New York, 10016, United States

  • Legacy Good Samaritan Medical Center-Gynecological Oncology Group

    WITHDRAWN

    Portland, Oregon, 97210, United States

  • Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology

    WITHDRAWN

    Tualatin, Oregon, 97062, United States

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

    WITHDRAWN

    Vancouver, Washington, 98686, United States

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

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Magee - Womens Hospital of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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

    RECRUITING

    Scarborough, Maine, 04074, United States

  • McGill University Health Centre-Glen Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering (Basking Ridge)

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering (Bergen)

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering (Commack)

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering (Monmouth)

    RECRUITING

    Middletown, New York, 07748, United States

  • Memorial Sloan Kettering (Nassau)

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering (Westchester)

    RECRUITING

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering Cancer Center (Main Campus)

    RECRUITING

    New York, New York, 10065, United States

  • Mercy Hospital

    RECRUITING

    Miami, Florida, 33133, United States

  • Mercy Hospital

    RECRUITING

    Miami, Florida, 33173, United States

  • Miami Cancer Institute at Baptist Health, Inc.

    RECRUITING

    Miami, Florida, 33176, United States

  • Miami Cancer Institute at Baptist Health, Inc.

    RECRUITING

    Miami, Florida, 33176, United States

  • Minnesota Oncology Hematology

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Mount Sinai Comprehensive Cancer Center

    WITHDRAWN

    Miami, Florida, 33140, United States

  • NHPP/Gynecologic Oncology at New Hyde Park

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • NYU Langone Ambulatory Care Bay Ridge

    RECRUITING

    Brooklyn, New York, 11220, United States

  • NYU Langone Hospital-Brooklym

    RECRUITING

    Brooklyn, New York, 11220, United States

  • NYU Langone Medical Center (Tisch Hospital)

    RECRUITING

    New York, New York, 10016, United States

  • Northwell Health Physician Partners/Gynecological Oncology at Brightwaters

    RECRUITING

    Brightwaters, New York, 11718, United States

  • Northwell Health/Huntington Hospital

    RECRUITING

    Huntington, New York, 11743, United States

  • Northwell Health/Long Island Jewish Medical Center

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • Northwell Health/South Shore University Hospital

    RECRUITING

    Bay Shore, New York, 11706, United States

  • Novant Health Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Novant Health Cancer Institute

    RECRUITING

    Greensboro, North Carolina, 27403, United States

  • Novant Health Cancer Institute

    RECRUITING

    Kernersville, North Carolina, 27284, United States

  • Novant Health Cancer Institute

    RECRUITING

    Mount Airy, North Carolina, 27030, United States

  • Novant Health Cancer Institute

    RECRUITING

    North Wilkesboro, North Carolina, 28659, United States

  • Novant Health Cancer Institute

    RECRUITING

    Statesville, North Carolina, 28625, United States

  • Novant Health Cancer Institute

    RECRUITING

    Thomasville, North Carolina, 27360, United States

  • Novant Health Cancer Institute

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • OSU Wexner Medical Center Hospital East

    RECRUITING

    Columbus, Ohio, 43203, United States

  • OSU Wexner Medical Center Martha Morehouse Outpatient Care

    RECRUITING

    Columbus, Ohio, 43221, United States

  • OSU Wexner Medical Center Outpatient Care Dublin

    RECRUITING

    Dublin, Ohio, 43016, United States

  • OSU Wexner Medical Center Outpatient Care East

    RECRUITING

    Columbus, Ohio, 43203, United States

  • OSU Wexner Medical Center Outpatient Care Gahanna

    RECRUITING

    Columbus, Ohio, 43230, United States

  • OSU Wexner Medical Center Outpatient Care Lewis Center

    RECRUITING

    Lewis Center, Ohio, 43035, United States

  • OSU Wexner Medical Center Outpatient Care New Albany

    RECRUITING

    Westerville, Ohio, 43081, United States

  • OSU Wexner Medical Center Outpatient Care Upper Arlington

    RECRUITING

    Columbus, Ohio, 43221, United States

  • OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center

    RECRUITING

    Columbus, Ohio, 43212, United States

  • OSU Wexner Medical Center University Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Orlando Health Cancer Center

    WITHDRAWN

    Orlando, Florida, 32806, United States

  • Orlando Health Winnie Palmer Hospital for Woman and Babies

    WITHDRAWN

    Orlando, Florida, 32806, United States

  • Palo Alto Medical Foundation

    WITHDRAWN

    Palo Alto, California, 94040, United States

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G2M9, Canada

  • Providence Center Institute Franz Clinic

    RECRUITING

    Portland, Oregon, 97213, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul St. Mary's Hospital - Catholic University

    RECRUITING

    Seoul, 06591, South Korea

  • Severance Hospital - Yonsei Cancer Center

    RECRUITING

    Seoul, Republic of Korea, 07722, South Korea

  • Severance Hospital - Yonsei Cancer Center

    RECRUITING

    Seoul, 07722, South Korea

  • South Miami Hospital

    RECRUITING

    Miami, Florida, 33143, United States

  • South Miami Hospital

    RECRUITING

    Miami, Florida, 33143, United States

  • Southeastern Regional Medical Center LLC

    WITHDRAWN

    Newnan, Georgia, 30265, United States

  • St. Elizabeth Healthcare

    ACTIVE_NOT_RECRUITING

    Edgewood, Kentucky, 41017, United States

  • St. Vincent Hospital and Health Care Center Inc

    WITHDRAWN

    Indianapolis, Indiana, 46260, United States

  • St. Vincent Hospital and Health Care Center, Inc

    WITHDRAWN

    Indianapolis, Indiana, 46260, United States

  • Stanford Hospital

    RECRUITING

    Palo Alto, California, 94305, United States

  • Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Summa Health Jean and Milton Copper Pavilion

    RECRUITING

    Akron, Ohio, 44304, United States

  • Summa Health Jean and Milton Copper Pavillion

    RECRUITING

    Akron, Ohio, 44304, United States

  • Tampa General Hospital

    WITHDRAWN

    Tampa, Florida, 33606, United States

  • Texas Oncology

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Texas Oncology- GYN ONC DFWW

    RECRUITING

    Bedford, Texas, 76022, United States

  • Texas Oncology-Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • Texas Oncology-DFWW

    RECRUITING

    Bedford, Texas, 76022, United States

  • Texas Oncology-GYN ONC DFWW

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Texas Oncology-San Antonio

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Texas Oncology-The Woodlands, Gynecologic Oncology

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • The Blavatnik Family - Chelsea Medical Center at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • The West Clinic, PLLC dba West Cancer Center

    RECRUITING

    Germantown, Tennessee, 38119, United States

  • TriHealth Cancer Institute-Good Samaritan Hospital

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45220, United States

  • TriHealth Cancer Institute-Thomas Comprehensive Care Center

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45220, United States

  • UCLA Gynecologic Oncology Clinic

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California San Diego Medical Center

    RECRUITING

    Encinitas, California, 92024, United States

  • University of California San Diego Medical Center

    RECRUITING

    La Jolla, California, 92037, United States

  • University of California San Diego Medical Center

    RECRUITING

    San Diego, California, 92103, United States

  • University of California San Diego Medical Center

    RECRUITING

    Vista, California, 92081, United States

  • University of California San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of New Mexico Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Albuquerque, New Mexico, 87131, United States

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

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Texas Southwestern Medical Center-Simmons Cancer Center

    RECRUITING

    Dallas, Texas, 75390, United States

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

    RECRUITING

    Dallas, Texas, 75390, United States

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

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Virginia Comprehensive Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin Clinical Science Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • VCU Health Emergency Center at New Kent

    RECRUITING

    Quinton, Virginia, 23141, United States

  • VCU Health Short Pump Pavillion

    RECRUITING

    Richmond, Virginia, 23233, United States

  • VCU Health at GreenGate

    RECRUITING

    Henrico, Virginia, 23233, United States

  • VCU Health at Tappahannock Hospital

    ACTIVE_NOT_RECRUITING

    Tappahannock, Virginia, 25560, United States

  • VCU Health-William and Mary

    RECRUITING

    Williamsburg, Virginia, 23185, United States

  • VCU Massey Cancer Center at Stony Point

    RECRUITING

    Richmond, Virginia, 23235, United States

  • Virginia Commonwealth University Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Virginia Commonwealth University-Main Hospital

    RECRUITING

    Richmond, Virginia, 23298, United States

  • West Virginia

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Western Regional Medical Center LLC

    WITHDRAWN

    Goodyear, Arizona, 85338, United States

  • Willis-Knighton Physician Network Gynecologic Oncology Associates

    RECRUITING

    Shreveport, Louisiana, 71118, United States

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

    RECRUITING

    Providence, Rhode Island, 02905, United States

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