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Spots Global Cancer Trial Database for A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

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Trial Identification

Brief Title: A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

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

Study ID: NCT04831580

Conditions

Cervical Cancer

Study Description

Brief Summary: 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.

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)

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Western Regional Medical Center LLC, Goodyear, Arizona, United States

University of California San Diego Medical Center, Encinitas, California, United States

University of California San Diego Medical Center, La Jolla, 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

University of California San Diego Medical Center, San Diego, California, United States

California Pacific Medical Center-Research Institute, San Francisco, California, United States

University of California San Diego Medical Center, Vista, California, United States

Hartford Hospital, Hartford, Connecticut, United States

Hartford Healthcare Cancer Institute at Hartford Hospital, Hartford, 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

Mercy Hospital, 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

M Health Fairview University of Minnesota Medical Center-East Bank Hospital, Minneapolis, Minnesota, United States

David C. Pratt Center, Saint 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, Brooklyn, 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

Laura and Issac Perlmutter Cancer Center at NYU Langone, 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, Charlotte, North Carolina, United States

Novant Health Cancer Institute, Greensboro, North Carolina, United States

Novant Health Cancer Institute, Kernersville, North Carolina, United States

Novant Health Cancer Institute, Mount Airy, North Carolina, United States

Novant Health Cancer Institute, North Wilkesboro, North Carolina, United States

FirstHealth Outpatient Cancer Center, Pinehurst, North Carolina, United States

Novant Health Cancer Institute, Statesville, North Carolina, United States

Novant Health Cancer Institute, Thomasville, North Carolina, United States

Novant Health Cancer Institute, Winston-Salem, 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

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

Contact Details

Name: Kristin Bixel, MD

Affiliation: The Ohio State Unversity

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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