A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
- Conditions
- Cervical Cancer
- Interventions
- Device: da VinciOther: open surgery
- Registration Number
- NCT04831580
- Lead Sponsor
- GOG Foundation
- Brief 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.
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 840
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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
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Robotic radical or simple hysterectomy da Vinci - Open radical or simple hysterectomy open surgery -
- Primary Outcome Measures
Name Time Method Survival 36 months 3 year disease-free survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (120)
Minnesota Oncology Hematology
🇺🇸Minneapolis, Minnesota, United States
Western Regional Medical Center LLC
🇺🇸Goodyear, Arizona, United States
City of Hope
🇺🇸Duarte, California, United States
University of California San Diego Medical Center
🇺🇸Vista, California, United States
City of Hope Orange County Lennar Foundation Cancer
🇺🇸Irvine, California, United States
University of California San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Hoag Gynecologic Oncology
🇺🇸Newport Beach, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Palo Alto Medical Foundation
🇺🇸Palo Alto, California, United States
Stanford Hospital
🇺🇸Palo Alto, California, United States
California Pacific Medical Center-Research Institute
🇺🇸San Francisco, California, United States
City of Hope - Upland
🇺🇸Upland, California, United States
Hartford Healthcare Cancer Institute at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Hartford Hospital
🇺🇸Hatford, Connecticut, United States
Hartford Healthcare Medical Group-Manchester
🇺🇸Manchester, Connecticut, United States
Harford HealthCare Cancer Institute at the Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Ascension Medical Group St. Vincent's Obstetrics and Gynecology
🇺🇸Jacksonville, Florida, United States
Mercy Hospital
🇺🇸Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
South Miami Hospital
🇺🇸Miami, Florida, United States
Miami Cancer Institute at Baptist Health, Inc.
🇺🇸Miami, Florida, United States
Orlando Health Cancer Center
🇺🇸Orlando, Florida, United States
Orlando Health Winnie Palmer Hospital for Woman and Babies
🇺🇸Orlando, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Georgian Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
Southeastern Regional Medical Center LLC
🇺🇸Newnan, Georgia, United States
St. Vincent Hospital and Health Care Center Inc
🇺🇸Indianapolis, Indiana, United States
St. Vincent Hospital and Health Care Center, Inc
🇺🇸Indianapolis, Indiana, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Baptist Health
🇺🇸Lexington, Kentucky, United States
LSU Health New Orleans
🇺🇸New Orleans, Louisiana, United States
Willis-Knighton Physician Network Gynecologic Oncology Associates
🇺🇸Shreveport, Louisiana, United States
Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology
🇺🇸Scarborough, Maine, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
🇺🇸Minneapolis, Minnesota, United States
David C. Pratt Center
🇺🇸St. Louis, Missouri, United States
Center of Hope
🇺🇸Reno, Nevada, United States
Memorial Sloan Kettering (Basking Ridge)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering (Bergen)
🇺🇸Montvale, New Jersey, United States
University of New Mexico Comprehensive Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Northwell Health/South Shore University Hospital
🇺🇸Bay Shore, New York, United States
Northwell Health Physician Partners/Gynecological Oncology at Brightwaters
🇺🇸Brightwaters, New York, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
🇺🇸New York, New York, United States
NYU Langone Ambulatory Care Bay Ridge
🇺🇸Brooklyn, New York, United States
NYU Langone Hospital-Brooklym
🇺🇸Brooklyn, New York, United States
Memorial Sloan Kettering (Commack)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering (Westchester)
🇺🇸Harrison, New York, United States
Northwell Health/Huntington Hospital
🇺🇸Huntington, New York, United States
Memorial Sloan Kettering (Monmouth)
🇺🇸Middletown, New York, United States
Northwell Health/Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
NHPP/Gynecologic Oncology at New Hyde Park
🇺🇸New Hyde Park, New York, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street
🇺🇸New York, New York, United States
NYU Langone Medical Center (Tisch Hospital)
🇺🇸New York, New York, United States
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
🇺🇸New York, New York, United States
Josie Robertson Surgery Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center (Main Campus)
🇺🇸New York, New York, United States
Memorial Sloan Kettering (Nassau)
🇺🇸Uniondale, New York, United States
Novant Health Cancer Institute
🇺🇸Winston-Salem, North Carolina, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Duke Cancer Center
🇺🇸Durham, North Carolina, United States
FirstHealth Outpatient Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Summa Health Jean and Milton Copper Pavilion
🇺🇸Akron, Ohio, United States
Summa Health Jean and Milton Copper Pavillion
🇺🇸Akron, Ohio, United States
TriHealth Cancer Institute-Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
TriHealth Cancer Institute-Thomas Comprehensive Care Center
🇺🇸Cincinnati, Ohio, United States
University of Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
OSU Wexner Medical Center Hospital East
🇺🇸Columbus, Ohio, United States
OSU Wexner Medical Center Outpatient Care East
🇺🇸Columbus, Ohio, United States
James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
OSU Wexner Medical Center University Hospital
🇺🇸Columbus, Ohio, United States
OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center
🇺🇸Columbus, Ohio, United States
OSU Wexner Medical Center Martha Morehouse Outpatient Care
🇺🇸Columbus, Ohio, United States
OSU Wexner Medical Center Outpatient Care Upper Arlington
🇺🇸Columbus, Ohio, United States
OSU Wexner Medical Center Outpatient Care Gahanna
🇺🇸Columbus, Ohio, United States
OSU Wexner Medical Center Outpatient Care Dublin
🇺🇸Dublin, Ohio, United States
JamesCare Gynecologic Oncology at Mill Run
🇺🇸Hilliard, Ohio, United States
Kettering Health Cancer Center
🇺🇸Kettering, Ohio, United States
OSU Wexner Medical Center Outpatient Care Lewis Center
🇺🇸Lewis Center, Ohio, United States
OSU Wexner Medical Center Outpatient Care New Albany
🇺🇸Westerville, Ohio, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Legacy Good Samaritan Medical Center-Gynecological Oncology Group
🇺🇸Portland, Oregon, United States
Providence Center Institute Franz Clinic
🇺🇸Portland, Oregon, United States
Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology
🇺🇸Tualatin, Oregon, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Magee - Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
AHN West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Asplundh Cancer Pavillion
🇺🇸Willow Grove, Pennsylvania, United States
Women's and Infants Hospital of Rhode Island Program in Women's Oncology
🇺🇸Providence, Rhode Island, United States
Chattanooga's Program in Women's Oncology
🇺🇸Chattanooga, Tennessee, United States
The West Clinic, PLLC dba West Cancer Center
🇺🇸Germantown, Tennessee, United States
Texas Oncology-Austin
🇺🇸Austin, Texas, United States
Texas Oncology- GYN ONC DFWW
🇺🇸Bedford, Texas, United States
Texas Oncology-DFWW
🇺🇸Bedford, Texas, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center-Simmons Cancer Center
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Texas Oncology-GYN ONC DFWW
🇺🇸Fort Worth, Texas, United States
Texas Oncology
🇺🇸Fort Worth, Texas, United States
Texas Oncology-San Antonio
🇺🇸San Antonio, Texas, United States
Texas Oncology-The Woodlands, Gynecologic Oncology
🇺🇸The Woodlands, Texas, United States
University of Virginia Comprehensive Cancer Center
🇺🇸Charlottesville, Virginia, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
VCU Health at GreenGate
🇺🇸Henrico, Virginia, United States
VCU Health Emergency Center at New Kent
🇺🇸Quinton, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
VCU Health Short Pump Pavillion
🇺🇸Richmond, Virginia, United States
VCU Massey Cancer Center at Stony Point
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University-Main Hospital
🇺🇸Richmond, Virginia, United States
VCU Health at Tappahannock Hospital
🇺🇸Tappahannock, Virginia, United States
VCU Health-William and Mary
🇺🇸Williamsburg, Virginia, United States
Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology
🇺🇸Vancouver, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
West Virginia
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin Clinical Science Center
🇺🇸Madison, Wisconsin, United States
McGill University Health Centre-Glen Site
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier De L'Universite De Montreal
🇨🇦Montréal, Canada