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| Name | Class |
|---|---|
| Intuitive Foundation | UNKNOWN |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open radical or simple hysterectomy | Active Comparator |
| |
| Robotic radical or simple hysterectomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci | Device | Minimally invasive robotic-assisted radical or simple hysterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 3 year disease-free survival | 36 months |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Klein, MEd | Contact | 215-854-0770 | jklein@gog.org |
| Name | Affiliation | Role |
|---|---|---|
| Kristin Bixel, MD | Standford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Regional Medical Center LLC | Recruiting | Goodyear | Arizona | 85338 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40188007 | Derived | 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. | |
| 37650664 |
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| open surgery | Other | open radical or simple hysterectomy |
|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
|
| University of California San Diego Medical Center | Recruiting | Encinitas | California | 92024 | United States |
|
| City of Hope Orange County Lennar Foundation Cancer | Recruiting | Irvine | California | 92618 | United States |
|
| University of California San Diego Medical Center | Recruiting | La Jolla | California | 92037 | United States |
|
| University of California San Diego Moores Cancer Center | Recruiting | La Jolla | California | 92093 | United States |
|
| Hoag Gynecologic Oncology | Recruiting | Newport Beach | California | 92633 | United States |
|
| Hoag Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92663 | United States |
|
| Palo Alto Medical Foundation | Recruiting | Palo Alto | California | 94040 | United States |
|
| Stanford Hospital | Recruiting | Palo Alto | California | 94305 | United States |
|
| University of California San Diego Medical Center | Recruiting | San Diego | California | 92103 | United States |
|
| California Pacific Medical Center-Research Institute | Recruiting | San Francisco | California | 91409 | United States |
|
| City of Hope - Upland | Recruiting | Upland | California | 91786 | United States |
|
| University of California San Diego Medical Center | Recruiting | Vista | California | 92081 | United States |
|
| Hartford Healthcare Cancer Institute at Hartford Hospital | Recruiting | Hartford | Connecticut | 06106 | United States |
|
| Hartford Hospital | Recruiting | Hatford | Connecticut | 06102 | United States |
|
| Hartford Healthcare Medical Group-Manchester | Recruiting | Manchester | Connecticut | 06042 | United States |
|
| Harford HealthCare Cancer Institute at the Hospital of Central Connecticut | Recruiting | New Britain | Connecticut | 06053 | United States |
|
| Ascension Medical Group St. Vincent's Obstetrics and Gynecology | Recruiting | Jacksonville | Florida | 32204 | United States |
|
| Mercy Hospital | Recruiting | Miami | Florida | 33133 | United States |
|
| Mount Sinai Comprehensive Cancer Center | Withdrawn | Miami | Florida | 33140 | United States |
| South Miami Hospital | Recruiting | Miami | Florida | 33143 | United States |
|
| South Miami Hospital | Recruiting | Miami | Florida | 33143 | 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 |
|
| Orlando Health Cancer Center | Withdrawn | Orlando | Florida | 32806 | United States |
| Orlando Health Winnie Palmer Hospital for Woman and Babies | Recruiting | Orlando | Florida | 32806 | United States |
|
| Tampa General Hospital | Withdrawn | Tampa | Florida | 33606 | United States |
| Georgian Cancer Center at Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
|
| Southeastern Regional Medical Center LLC | Recruiting | Newnan | Georgia | 30265 | 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 |
| St. Elizabeth Healthcare | Recruiting | Edgewood | Kentucky | 41017 | United States |
|
| Baptist Health Lexington | Recruiting | Lexington | Kentucky | 40503 | United States |
|
| Baptist Health | Recruiting | Lexington | Kentucky | 40503 | United States |
|
| LSU Health New Orleans | Recruiting | New Orleans | Louisiana | 70112 | United States |
|
| Willis-Knighton Physician Network Gynecologic Oncology Associates | Recruiting | Shreveport | Louisiana | 71118 | United States |
|
| Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology | Recruiting | Scarborough | Maine | 04074 | United States |
|
| Baystate Medical Center | Withdrawn | Springfield | Massachusetts | 01199 | United States |
| Minnesota Oncology Hematology | Recruiting | Minneapolis | Minnesota | 55404 | 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 |
|
| David C. Pratt Center | Recruiting | St Louis | Missouri | 63141 | United States |
|
| Center of Hope | Recruiting | Reno | Nevada | 89511 | United States |
|
| Memorial Sloan Kettering (Basking Ridge) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
|
| Memorial Sloan Kettering (Bergen) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| University of New Mexico Comprehensive Cancer Center | Recruiting | Albuquerque | New Mexico | 87131 | United States |
|
| Northwell Health/South Shore University Hospital | Recruiting | Bay Shore | New York | 11706 | United States |
|
| Northwell Health Physician Partners/Gynecological Oncology at Brightwaters | Recruiting | Brightwaters | New York | 11718 | United States |
|
| Laura and Issac Perlmutter Cancer Center at NYU Langone | Recruiting | Brooklyn | New York | 11220 | 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 |
|
| Memorial Sloan Kettering (Commack) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering (Westchester) | Recruiting | Harrison | New York | 10604 | United States |
|
| Northwell Health/Huntington Hospital | Recruiting | Huntington | New York | 11743 | United States |
|
| Memorial Sloan Kettering (Monmouth) | Recruiting | Middletown | New York | 07748 | United States |
|
| Northwell Health/Long Island Jewish Medical Center | Recruiting | New Hyde Park | New York | 11040 | United States |
|
| NHPP/Gynecologic Oncology at New Hyde Park | Recruiting | New Hyde Park | New York | 11042 | United States |
|
| Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street | Recruiting | New York | New York | 10016 | United States |
|
| Laura and Issac Perlmutter Cancer Center at NYU Langone | Recruiting | New York | New York | 10016 | United States |
|
| NYU Langone Medical Center (Tisch Hospital) | Recruiting | New York | New York | 10016 | United States |
|
| The Blavatnik Family - Chelsea Medical Center at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Josie Robertson Surgery Center | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Cancer Center (Main Campus) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering (Nassau) | Recruiting | Uniondale | New York | 11553 | United States |
|
| Novant Health Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
|
| Duke University Hospital | Recruiting | Durham | North Carolina | 27705 | United States |
|
| Duke Cancer Center | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Duke Cancer Center | Recruiting | Durham | North Carolina | 27710 | 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 |
|
| FirstHealth Outpatient Cancer Center | Recruiting | Pinehurst | North Carolina | 28374 | 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 |
|
| 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 |
|
| TriHealth Cancer Institute-Good Samaritan Hospital | Recruiting | Cincinnati | Ohio | 45220 | United States |
|
| TriHealth Cancer Institute-Thomas Comprehensive Care Center | Recruiting | Cincinnati | Ohio | 45220 | United States |
|
| University of Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| OSU Wexner Medical Center Hospital East | Recruiting | Columbus | Ohio | 43203 | United States |
|
| OSU Wexner Medical Center Outpatient Care East | Recruiting | Columbus | Ohio | 43203 | United States |
|
| James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
|
| OSU Wexner Medical Center University Hospital | Recruiting | Columbus | Ohio | 43210 | United States |
|
| OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center | Recruiting | Columbus | Ohio | 43212 | United States |
|
| OSU Wexner Medical Center Martha Morehouse Outpatient Care | Recruiting | Columbus | Ohio | 43221 | United States |
|
| OSU Wexner Medical Center Outpatient Care Upper Arlington | Recruiting | Columbus | Ohio | 43221 | United States |
|
| OSU Wexner Medical Center Outpatient Care Gahanna | Recruiting | Columbus | Ohio | 43230 | United States |
|
| OSU Wexner Medical Center Outpatient Care Dublin | Recruiting | Dublin | Ohio | 43016 | United States |
|
| JamesCare Gynecologic Oncology at Mill Run | Recruiting | Hilliard | Ohio | 43026 | United States |
|
| Kettering Health Cancer Center | Recruiting | Kettering | Ohio | 45429 | 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 |
|
| Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| Legacy Good Samaritan Medical Center-Gynecological Oncology Group | Withdrawn | Portland | Oregon | 97210 | United States |
| Providence Center Institute Franz Clinic | Recruiting | Portland | Oregon | 97213 | United States |
|
| Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology | Withdrawn | Tualatin | Oregon | 97062 | United States |
| Abington Memorial Hospital | Recruiting | Abington | Pennsylvania | 19001 | United States |
|
| University of Pennsylvania Health System, Perelman Center for Advanced Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Magee - Womens Hospital of UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| AHN West Penn Hospital | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
|
| Asplundh Cancer Pavillion | Recruiting | Willow Grove | Pennsylvania | 19090 | United States |
|
| Women's and Infants Hospital of Rhode Island Program in Women's Oncology | Recruiting | Providence | Rhode Island | 02905 | United States |
|
| Chattanooga's Program in Women's Oncology | Recruiting | Chattanooga | Tennessee | 37403 | United States |
|
| The West Clinic, PLLC dba West Cancer Center | Recruiting | Germantown | Tennessee | 38119 | United States |
|
| Texas Oncology-Austin | Recruiting | Austin | Texas | 78758 | United States |
|
| Texas Oncology- GYN ONC DFWW | Recruiting | Bedford | Texas | 76022 | United States |
|
| Texas Oncology-DFWW | Recruiting | Bedford | Texas | 76022 | United States |
|
| Texas Oncology- Baylor Charles A. Sammons Cancer Center | Recruiting | Dallas | Texas | 75246 | 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 Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|
| Texas Oncology-GYN ONC DFWW | Recruiting | Fort Worth | Texas | 76104 | United States |
|
| Texas Oncology | 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 |
|
| University of Virginia Comprehensive Cancer Center | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| VCU Health at GreenGate | Recruiting | Henrico | Virginia | 23233 | United States |
|
| VCU Health Emergency Center at New Kent | Recruiting | Quinton | Virginia | 23141 | United States |
|
| Virginia Commonwealth University Massey Cancer Center | Recruiting | Richmond | Virginia | 23219 | United States |
|
| VCU Health Short Pump Pavillion | Recruiting | Richmond | Virginia | 23233 | United States |
|
| VCU Massey Cancer Center at Stony Point | Recruiting | Richmond | Virginia | 23235 | United States |
|
| Virginia Commonwealth University-Main Hospital | Recruiting | Richmond | Virginia | 23298 | United States |
|
| VCU Health at Tappahannock Hospital | Recruiting | Tappahannock | Virginia | 25560 | United States |
|
| VCU Health-William and Mary | Recruiting | Williamsburg | Virginia | 23185 | United States |
|
| Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology | Recruiting | Vancouver | Washington | 98686 | United States |
|
| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
|
| West Virginia | Recruiting | Morgantown | West Virginia | 26506 | United States |
|
| University of Wisconsin Clinical Science Center | Recruiting | Madison | Wisconsin | 53792 | United States |
|
| McGill University Health Centre-Glen Site | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
|
| Centre Hospitalier De L'Universite De Montreal | Recruiting | Montreal | H2X 3E4 | Canada |
|
| 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. |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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