A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

Last updated: December 16, 2024
Sponsor: GOG Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Cancer

Dysfunctional Uterine Bleeding

Pelvic Cancer

Treatment

da Vinci

open surgery

Clinical Study ID

NCT04831580
GOG-3043
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 ofdefinitive 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 torandomization are eligible.

  3. Patient must have uterine size <12 cm AND felt to be appropriate for vaginaldelivery of the specimen per investigator.

  4. Patient must be suitable surgical candidate with preoperative assessments such aslabs and EKG performed per institutional standard and agree to be randomized toundergo open or robotic radical (or simple) hysterectomy. NOTE: Simple hysterectomy will be allowed in patients who meet the followingcriteria:

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

  6. less than 50% stromal invasion on MRI if tumor present or less than 10 mm ofstromal invasion if an excisional (cold knife or LEEP) has been performed. Submission of source documents in the GOG Partners Source Document Portal will berequired prior to randomization for review and confirmation of simple hysterectomybeing met (see Section 6.0 for instructions).

  7. Patient must be age 18 years or older.

  8. Patient must have ECOG performance status 0-1.

  9. Patient must have a negative urine pregnancy test within 30 days of surgery inpre-menopausal women.

  10. Patient must have signed an approved informed consent and authorization permittingthe release of personal health information.

Exclusion

Exclusion Criteria:

  1. Patients with any tumor histology other than those listed above, specificallyexcluding the following histologies: neuroendocrine, other adenocarcinoma (gastrictype, 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 torandomization are excluded. Patients with definite evidence of vaginal/parametrialinvolvement on MRI are excluded; if MRI findings are not definitive, then clinicalexamination must also not reveal parametrial or vaginal extension).

  5. Patients with evidence of metastatic disease (imaging or histologically positivelymph 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 ofnon-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 Design

Total Participants: 840
Treatment Group(s): 2
Primary Treatment: da Vinci
Phase:
Study Start date:
March 22, 2022
Estimated Completion Date:
August 31, 2029

Study 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)

Connect with a study center

  • McGill University Health Centre-Glen Site

    Montréal, Quebec H4A 3J1
    Canada

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  • Centre Hospitalier De L'Universite De Montreal

    Montréal, H2X 3E4
    Canada

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  • Palo Alto Medical Foundation

    Palo Alto, California 94040
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  • Stanford Hospital

    Palo Alto, California 94305
    United States

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  • University of California San Diego Medical Center

    San Diego, California 92103
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    San Francisco, California 91409
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    Upland, California 91786
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    Vista, California 92081
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    Hartford, Connecticut 06106
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    Hartford, Connecticut 06102
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    Manchester, Connecticut 06042
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    New Britain, Connecticut 06053
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    Tampa, Florida 33606
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    Indianapolis, Indiana 46260
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    Indianapolis, Indiana 46260
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    Edgewood, Kentucky 41017
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  • Baystate Medical Center

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  • OSU Wexner Medical Center Martha Morehouse Outpatient Care

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  • OSU Wexner Medical Center Outpatient Care East

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  • OSU Wexner Medical Center Outpatient Care Gahanna

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  • OSU Wexner Medical Center Outpatient Care Upper Arlington

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  • OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio 43212
    United States

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  • OSU Wexner Medical Center University Hospital

    Columbus, Ohio 43210
    United States

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  • OSU Wexner Medical Center Outpatient Care Dublin

    Dublin, Ohio 43016
    United States

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  • JamesCare Gynecologic Oncology at Mill Run

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    United States

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  • Kettering Health Cancer Center

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  • OSU Wexner Medical Center Outpatient Care Lewis Center

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    United States

    Active - Recruiting

  • OSU Wexner Medical Center Outpatient Care New Albany

    Westerville, Ohio 43081
    United States

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  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

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  • Legacy Good Samaritan Medical Center-Gynecological Oncology Group

    Portland, Oregon 97210
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    Site Not Available

  • Providence Center Institute Franz Clinic

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology

    Tualatin, Oregon 97062
    United States

    Site Not Available

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

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

    Philadelphia, Pennsylvania 19104
    United States

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  • AHN West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

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  • Magee - Womens Hospital of UPMC

    Pittsburgh, Pennsylvania 15213
    United States

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  • Asplundh Cancer Pavillion

    Willow Grove, Pennsylvania 19090
    United States

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

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee 37403
    United States

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  • The West Clinic, PLLC dba West Cancer Center

    Germantown, Tennessee 38119
    United States

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  • Texas Oncology-Austin

    Austin, Texas 78758
    United States

    Active - Recruiting

  • Texas Oncology- GYN ONC DFWW

    Bedford, Texas 76022
    United States

    Active - Recruiting

  • Texas Oncology-DFWW

    Bedford, Texas 76022
    United States

    Active - Recruiting

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center-Simmons Cancer Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

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

    Dallas, Texas 75390
    United States

    Active - Recruiting

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

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Texas Oncology

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Texas Oncology-GYN ONC DFWW

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Texas Oncology-San Antonio

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Texas Oncology-The Woodlands, Gynecologic Oncology

    The Woodlands, Texas 77380
    United States

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  • University of Virginia

    Charlottesville, Virginia 22903
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  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia 22903
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  • VCU Health at GreenGate

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  • VCU Health Emergency Center at New Kent

    Quinton, Virginia 23141
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  • VCU Health Short Pump Pavillion

    Richmond, Virginia 23233
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  • VCU Massey Cancer Center at Stony Point

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  • Virginia Commonwealth University Massey Cancer Center

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    Richmond, Virginia 23298
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    Tappahannock, Virginia 25560
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  • VCU Health-William and Mary

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

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  • West Virginia

    Morgantown, West Virginia 26506
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    Morgantown, West Virginia 26506
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  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin 53792
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