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

February 21, 2024 updated by: GOG Foundation

A Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC)

This is a randomized controlled trial to compare survival for patients who undergi robotic assisted laparoscopy versus open radical 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 radical hysterectomy with tumor containment prior to colpotomy is non-inferior to abdominal radical hysterectomy with respect to disease free survival.

A t 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 radical 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 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 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

  • Name: Jennifer Klein, MEd
  • Phone Number: 215-854-0770
  • Email: jklein@gog.org

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
    • California
      • Encinitas, California, United States, 92024
        • Recruiting
        • University of California San Diego Medical Center
        • Principal Investigator:
          • Ramez Eskander, MD
        • Contact:
          • Alexandrea Cronin
        • Contact:
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego Medical Center
        • Principal Investigator:
          • Ramez Eskander, MD
        • Contact:
          • Alexandrea Cronin
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego Moores Cancer Center
        • Principal Investigator:
          • Ramez Eskander, MD
        • Contact:
          • Alexandrea Cronin
        • 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, 94040
        • Recruiting
        • Palo Alto Medical Foundation
        • Contact:
        • Principal Investigator:
          • Ming-teh Dwight Chen, MD
      • San Diego, California, United States, 92103
        • Recruiting
        • University of California San Diego Medical Center
        • Principal Investigator:
          • Ramez Eskander, MD
        • Contact:
          • Alexandrea Cronin
        • Contact:
      • San Francisco, California, United States, 91409
        • Recruiting
        • California Pacific Medical Center-Research Institute
        • Contact:
        • Principal Investigator:
          • Ming-teh Dwight Chen, MD
      • Vista, California, United States, 92081
        • Recruiting
        • University of California San Diego Medical Center
        • Principal Investigator:
          • Ramez Eskander, MD
        • Contact:
          • Alexandrea Cronin
        • Contact:
    • 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, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Brian Slomovitz, MD
      • Miami, Florida, United States, 33133
      • Miami, Florida, United States, 33173
      • Orlando, Florida, United States, 32806
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Winnie Palmer Hospital for Woman and Babies
        • Contact:
        • Principal Investigator:
          • Shelly Seward, MD
      • Tampa, Florida, United States, 33606
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgian Cancer Center at Augusta University
        • Contact:
        • Principal Investigator:
          • Sharad Ghamande, MD
      • Newnan, Georgia, United States, 30265
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • St. Vincent Hospital and Health Care Center Inc
        • Contact:
        • Principal Investigator:
          • Sarah Goodrich, MD
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • St. Vincent Hospital and Health Care Center, Inc
        • Principal Investigator:
          • Sarah Goodrich, MD
        • Contact:
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington
        • Principal Investigator:
          • Monica Vetter, MD
        • Contact:
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health
        • Principal Investigator:
          • Monica Vetter, 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
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview University of Minnesota Medical Center-East Bank Hospital
        • Contact:
        • Principal Investigator:
          • Collen Rivard, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • David C. Pratt Center
        • Principal Investigator:
          • Dan-Arin Silasi, MD
        • Contact:
    • 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
        • Recruiting
        • University of New Mexico Comprehensive Cancer Center
        • Principal Investigator:
          • Colleen McCormick, MD
        • Contact:
    • 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
        • Contact:
        • Principal Investigator:
          • Ghadir Salame, MD
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Issac Perlmutter Cancer Center at NYU Langone
        • Contact:
        • Principal Investigator:
          • Ghadir Salame, MD
      • 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 Anderson, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Cancer Institute
        • Contact:
          • Kunal Shah
        • Contact:
        • Principal Investigator:
          • Elizabeth Skinner, 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
        • Recruiting
        • FirstHealth Outpatient Cancer Center
        • Contact:
        • Principal Investigator:
          • Michael Sundborg, MD
      • 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:
          • Stephen Andrews, MD
      • Akron, Ohio, United States, 44304
        • Recruiting
        • Summa Health Jean and Milton Copper Pavillion
        • Principal Investigator:
          • Stephen Andrews, MD
        • Contact:
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45220
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University of Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Kristine Zanotti, MD
      • Columbus, Ohio, United States, 43203
        • Recruiting
        • OSU Wexner Medical Center Hospital East
        • Contact:
        • Principal Investigator:
          • Crista Nagel, MD
      • Columbus, Ohio, United States, 43203
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care East
        • Principal Investigator:
          • Crista Nagel, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Crista Nagel, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • OSU Wexner Medical Center University Hospital
        • Contact:
        • Principal Investigator:
          • Crista Nagel, MD
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center
        • Contact:
        • Principal Investigator:
          • Crista Nagel, MD
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • OSU Wexner Medical Center Martha Morehouse Outpatient Care
        • Contact:
        • Principal Investigator:
          • Crista Nagel, MD
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care Upper Arlington
        • Contact:
        • Principal Investigator:
          • Crista Nagel, MD
      • Columbus, Ohio, United States, 43230
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care Gahanna
        • Contact:
        • Principal Investigator:
          • Crista Nagel, MD
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care Dublin
        • Contact:
        • Principal Investigator:
          • Crista Nagel, MD
      • Hilliard, Ohio, United States, 43026
        • Recruiting
        • JamesCare Gynecologic Oncology at Mill Run
        • Principal Investigator:
          • Crista Nagel, MD
        • Contact:
      • Kettering, Ohio, United States, 45429
      • Lewis Center, Ohio, United States, 43035
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care Lewis Center
        • Contact:
        • Principal Investigator:
          • Crista Nagel, MD
      • Westerville, Ohio, United States, 43081
        • Recruiting
        • OSU Wexner Medical Center Outpatient Care New Albany
        • Contact:
        • Principal Investigator:
          • Crista Nagel, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Medical Center-Gynecological Oncology Group
        • Contact:
        • Principal Investigator:
          • Gina Westoff, MD
      • Tualatin, Oregon, United States, 97062
        • Recruiting
        • Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology
        • Contact:
        • Principal Investigator:
          • Gina Westoff, MD
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
      • 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
    • 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:
          • Salvatore LoCoco, MD
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
        • Contact:
        • Principal Investigator:
          • Salvatore LoCoco, 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
      • Henrico, Virginia, United States, 23233
        • Recruiting
        • VCU Health at GreenGate
        • Contact:
        • Principal Investigator:
          • Stephanie Sullivan, MD
      • Quinton, Virginia, United States, 23141
        • Recruiting
        • VCU Health Emergency Center at New Kent
        • Contact:
        • Principal Investigator:
          • Stephanie Sullivan, MD
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • Stephanie Sullivan, MD
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Stephanie Sullivan, MD
      • Richmond, Virginia, United States, 23233
        • Recruiting
        • VCU Health Short Pump Pavillion
        • Contact:
        • Principal Investigator:
          • Stephanie Sullivan, MD
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University-Main Hospital
        • Contact:
        • Principal Investigator:
          • Stephanie Sullivan, MD
      • Tappahannock, Virginia, United States, 25560
        • Recruiting
        • VCU Health at Tappahannock Hospital
        • Contact:
        • Principal Investigator:
          • Stephanie Sullivan, MD
      • Williamsburg, Virginia, United States, 23185
        • Recruiting
        • VCU Health-William and Mary
        • Contact:
        • Principal Investigator:
          • Stephanie Sullivan, MD
    • Washington
      • Vancouver, Washington, United States, 98686
        • Recruiting
        • Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology
        • Contact:
        • Principal Investigator:
          • Gina Westoff, MD
    • 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.
  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 hysterectomy
Other: open surgery
open radical hysterectomy
Experimental: Robotic radical hysterectomy
Device: da Vinci
Minimally invasive robotic-assisted surgical device

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, The Ohio State Unversity

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)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

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)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

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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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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