RecruitingNot ApplicableNCT04831580

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer (ROCC)

Sponsor

GOG Foundation

Enrollment

840 participants

Start Date

Mar 22, 2022

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for early-stage cervical cancer: traditional open surgery versus robotic-assisted surgery (using a robotic system controlled by the surgeon). Previous research suggested open surgery may have better cancer outcomes — this trial aims to confirm that finding. **You may be eligible if...** - You have been diagnosed with early-stage cervical cancer (stage IA2, IB1, or IB2) confirmed by biopsy - Your tumor is no larger than 4 cm on MRI imaging - You are a suitable candidate for surgery - You agree to be randomly assigned to either open or robotic surgery **You may NOT be eligible if...** - Your cancer has spread beyond the cervix to surrounding tissue, lymph nodes, or distant organs - Your tumor is larger than 4 cm - Your uterus is too large for a standard surgical approach - You have another medical condition that makes surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEda Vinci

Minimally invasive robotic-assisted radical or simple hysterectomy

OTHERopen surgery

open radical or simple hysterectomy

Locations(136)

Western Regional Medical Center LLC

Goodyear, Arizona, United States

City of Hope

Duarte, California, United States

University of California San Diego Medical Center

Encinitas, California, United States

City of Hope Orange County Lennar Foundation Cancer

Irvine, 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

Stanford Hospital

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

City of Hope - Upland

Upland, California, United States

University of California San Diego Medical Center

Vista, 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

South Miami Hospital

Miami, Florida, United States

Mercy Hospital

Miami, Florida, United States

Miami Cancer Institute at Baptist Health, Inc.

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

Minnesota Oncology Hematology

Minneapolis, Minnesota, 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

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

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

Duke University Hospital

Durham, North Carolina, United States

Duke Cancer Center

Durham, North Carolina, United States

Duke Cancer Center

Durham, 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

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

Montreal, Quebec, Canada

Centre Hospitalier De L'Universite De Montreal

Montreal, Canada

View Full Details on ClinicalTrials.gov

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NCT04831580

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