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NCT04831580NARecruiting

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

GOG Foundation

Start Date

3/22/2022

Completion Date

3/1/2030

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)

Eligibility Criteria

Age Range: 18 years to No maximum

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 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. 3. Patient must have uterine size \<12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator. 4. 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: 1. pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND 2. 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). 5. Patient must be age 18 years or older. 6. Patient must have ECOG performance status 0-1. 7. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women. 8. Patient must have signed an approved informed consent and authorization permitting the release of personal health information. Exclusion Criteria: 1. 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) 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 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). 5. Patients with evidence of metastatic disease (imaging or histologically positive lymph 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 of non-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.

Interventions

DEVICE

da Vinci

OTHER

open surgery

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Conditions

Cervical Cancer

Locations

Western Regional Medical Center LLC

Goodyear, Arizona 85338

United States

City of Hope

Duarte, California 91010

United States

University of California San Diego Medical Center

Encinitas, California 92024

United States

City of Hope Orange County Lennar Foundation Cancer

Irvine, California 92618

United States

University of California San Diego Medical Center

La Jolla, California 92037

United States

University of California San Diego Moores Cancer Center

La Jolla, California 92093

United States

UCLA Gynecologic Oncology Clinic

Los Angeles, California 90095

United States

Hoag Gynecologic Oncology

Newport Beach, California 92633

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California 92663

United States

Palo Alto Medical Foundation

Palo Alto, California 94040

United States

Stanford Hospital

Palo Alto, California 94305

United States

University of California San Diego Medical Center

San Diego, California 92103

United States

California Pacific Medical Center-Research Institute

San Francisco, California 91409

United States

City of Hope - Upland

Upland, California 91786

United States

University of California San Diego Medical Center

Vista, California 92081

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

Hartford Healthcare Cancer Institute at Hartford Hospital

Hartford, Connecticut 06106

United States

Hartford Healthcare Medical Group-Manchester

Manchester, Connecticut 06042

United States

Harford HealthCare Cancer Institute at the Hospital of Central Connecticut

New Britain, Connecticut 06053

United States

Ascension Medical Group St. Vincent's Obstetrics and Gynecology

Jacksonville, Florida 32204

United States

Mercy Hospital

Miami, Florida 33133

United States

Mount Sinai Comprehensive Cancer Center

Miami, Florida 33140

United States

South Miami Hospital

Miami, Florida 33143

United States

South Miami Hospital

Miami, Florida 33143

United States

Mercy Hospital

Miami, Florida 33173

United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida 33176

United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida 33176

United States

Orlando Health Cancer Center

Orlando, Florida 32806

United States

Orlando Health Winnie Palmer Hospital for Woman and Babies

Orlando, Florida 32806

United States

Tampa General Hospital

Tampa, Florida 33606

United States

Georgian Cancer Center at Augusta University

Augusta, Georgia 30912

United States

Southeastern Regional Medical Center LLC

Newnan, Georgia 30265

United States

St. Vincent Hospital and Health Care Center Inc

Indianapolis, Indiana 46260

United States

St. Vincent Hospital and Health Care Center, Inc

Indianapolis, Indiana 46260

United States

St. Elizabeth Healthcare

Edgewood, Kentucky 41017

United States

Baptist Health Lexington

Lexington, Kentucky 40503

United States

Baptist Health

Lexington, Kentucky 40503

United States

LSU Health New Orleans

New Orleans, Louisiana 70112

United States

Willis-Knighton Physician Network Gynecologic Oncology Associates

Shreveport, Louisiana 71118

United States

Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology

Scarborough, Maine 04074

United States

Baystate Medical Center

Springfield, Massachusetts 01199

United States

Minnesota Oncology Hematology

Minneapolis, Minnesota 55404

United States

M Health Fairview University of Minnesota Medical Center-East Bank Hospital

Minneapolis, Minnesota 55455

United States

M Health Fairview University of Minnesota Medical Center-East Bank Hospital

Minneapolis, Minnesota 55455

United States

David C. Pratt Center

St Louis, Missouri 63141

United States

Center of Hope

Reno, Nevada 89511

United States

Memorial Sloan Kettering (Basking Ridge)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering (Bergen)

Montvale, New Jersey 07645

United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico 87131

United States

Northwell Health/South Shore University Hospital

Bay Shore, New York 11706

United States

Northwell Health Physician Partners/Gynecological Oncology at Brightwaters

Brightwaters, New York 11718

United States

Laura and Issac Perlmutter Cancer Center at NYU Langone

Brooklyn, New York 11220

United States

NYU Langone Ambulatory Care Bay Ridge

Brooklyn, New York 11220

United States

NYU Langone Hospital-Brooklym

Brooklyn, New York 11220

United States

Memorial Sloan Kettering (Commack)

Commack, New York 11725

United States

Memorial Sloan Kettering (Westchester)

Harrison, New York 10604

United States

Northwell Health/Huntington Hospital

Huntington, New York 11743

United States

Memorial Sloan Kettering (Monmouth)

Middletown, New York 07748

United States

Northwell Health/Long Island Jewish Medical Center

New Hyde Park, New York 11040

United States

NHPP/Gynecologic Oncology at New Hyde Park

New Hyde Park, New York 11042

United States

Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street

New York, New York 10016

United States

Laura and Issac Perlmutter Cancer Center at NYU Langone

New York, New York 10016

United States

NYU Langone Medical Center (Tisch Hospital)

New York, New York 10016

United States

The Blavatnik Family - Chelsea Medical Center at Mount Sinai

New York, New York 10029

United States

Josie Robertson Surgery Center

New York, New York 10065

United States

Memorial Sloan Kettering Cancer Center (Main Campus)

New York, New York 10065

United States

Memorial Sloan Kettering (Nassau)

Uniondale, New York 11553

United States

Novant Health Cancer Institute

Charlotte, North Carolina 28204

United States

Duke University Hospital

Durham, North Carolina 27705

United States

Duke Cancer Center

Durham, North Carolina 27710

United States

Duke Cancer Center

Durham, North Carolina 27710

United States

Novant Health Cancer Institute

Greensboro, North Carolina 27403

United States

Novant Health Cancer Institute

Kernersville, North Carolina 27284

United States

Novant Health Cancer Institute

Mount Airy, North Carolina 27030

United States

Novant Health Cancer Institute

North Wilkesboro, North Carolina 28659

United States

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina 28374

United States

Novant Health Cancer Institute

Statesville, North Carolina 28625

United States

Novant Health Cancer Institute

Thomasville, North Carolina 27360

United States

Novant Health Cancer Institute

Winston-Salem, North Carolina 27103

United States

Summa Health Jean and Milton Copper Pavilion

Akron, Ohio 44304

United States

Summa Health Jean and Milton Copper Pavillion

Akron, Ohio 44304

United States

TriHealth Cancer Institute-Good Samaritan Hospital

Cincinnati, Ohio 45220

United States

TriHealth Cancer Institute-Thomas Comprehensive Care Center

Cincinnati, Ohio 45220

United States

University of Cleveland Medical Center

Cleveland, Ohio 44106

United States

OSU Wexner Medical Center Hospital East

Columbus, Ohio 43203

United States

OSU Wexner Medical Center Outpatient Care East

Columbus, Ohio 43203

United States

James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Columbus, Ohio 43210

United States

OSU Wexner Medical Center University Hospital

Columbus, Ohio 43210

United States

OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio 43212

United States

OSU Wexner Medical Center Martha Morehouse Outpatient Care

Columbus, Ohio 43221

United States

OSU Wexner Medical Center Outpatient Care Upper Arlington

Columbus, Ohio 43221

United States

OSU Wexner Medical Center Outpatient Care Gahanna

Columbus, Ohio 43230

United States

OSU Wexner Medical Center Outpatient Care Dublin

Dublin, Ohio 43016

United States

JamesCare Gynecologic Oncology at Mill Run

Hilliard, Ohio 43026

United States

Kettering Health Cancer Center

Kettering, Ohio 45429

United States

OSU Wexner Medical Center Outpatient Care Lewis Center

Lewis Center, Ohio 43035

United States

OSU Wexner Medical Center Outpatient Care New Albany

Westerville, Ohio 43081

United States

Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

Legacy Good Samaritan Medical Center-Gynecological Oncology Group

Portland, Oregon 97210

United States

Providence Center Institute Franz Clinic

Portland, Oregon 97213

United States

Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology

Tualatin, Oregon 97062

United States

Abington Memorial Hospital

Abington, Pennsylvania 19001

United States

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania 19104

United States

Magee - Womens Hospital of UPMC

Pittsburgh, Pennsylvania 15213

United States

AHN West Penn Hospital

Pittsburgh, Pennsylvania 15224

United States

Asplundh Cancer Pavillion

Willow Grove, Pennsylvania 19090

United States

Alliance Cancer Specialists, PC

Wynnewood, Pennsylvania 19096

United States

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

Providence, Rhode Island 02905

United States

Chattanooga's Program in Women's Oncology

Chattanooga, Tennessee 37403

United States

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee 38119

United States

Texas Oncology-Austin

Austin, Texas 78758

United States

Texas Oncology- GYN ONC DFWW

Bedford, Texas 76022

United States

Texas Oncology-DFWW

Bedford, Texas 76022

United States

Texas Oncology- Baylor Charles A. Sammons Cancer Center

Dallas, Texas 75246

United States

University of Texas Southwestern Medical Center-Simmons Cancer Center

Dallas, Texas 75390

United States

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

Dallas, Texas 75390

United States

University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

Dallas, Texas 75390

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Texas Oncology-GYN ONC DFWW

Fort Worth, Texas 76104

United States

Texas Oncology

Fort Worth, Texas 76104

United States

Texas Oncology-San Antonio

San Antonio, Texas 78240

United States

Texas Oncology-The Woodlands, Gynecologic Oncology

The Woodlands, Texas 77380

United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia 22903

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Inova Health System

Fairfax, Virginia 22031

United States

VCU Health at GreenGate

Henrico, Virginia 23233

United States

VCU Health Emergency Center at New Kent

Quinton, Virginia 23141

United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia 23219

United States

VCU Health Short Pump Pavillion

Richmond, Virginia 23233

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia 23235

United States

Virginia Commonwealth University-Main Hospital

Richmond, Virginia 23298

United States

VCU Health at Tappahannock Hospital

Tappahannock, Virginia 25560

United States

VCU Health-William and Mary

Williamsburg, Virginia 23185

United States

Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology

Vancouver, Washington 98686

United States

West Virginia University

Morgantown, West Virginia 26506

United States

West Virginia

Morgantown, West Virginia 26506

United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin 53792

United States

Hospital Erasto Gaertner

Curitiba, Paraná 81520-060

Brazil

Hospital Municipal Vila Santa Catarina

São Paulo, Sao Paula 04378-500

Brazil

Barretos Cancer Hospital

Barretos, São Paulo 14784-400

Brazil

Hospital de Base - Fundacao Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo 15090-000

Brazil

A.C.Camargo Cancer Center

São Paulo, São Paulo 01509001

Brazil

Brazilian National Cancer Institute

Rio de Janeiro, 20081-250

Brazil

Princess Margaret Cancer Center

Toronto, Ontario M5G2M9

Canada

McGill University Health Centre-Glen Site

Montreal, Quebec H4A 3J1

Canada

Centre Hospitalier De L'Universite De Montreal

Montreal, H2X 3E4

Canada

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do 13496

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Gangnam Severance Hospital

Seoul, Republic of Korea 06273

South Korea

Severance Hospital - Yonsei Cancer Center

Seoul, Republic of Korea 07722

South Korea

Korea University Guro Hospital

Seoul, Republic of Korea 08308

South Korea

Korea University Anam Hospital

Seoul, 02843

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Seoul St. Mary's Hospital - Catholic University

Seoul, 06591

South Korea

Severance Hospital - Yonsei Cancer Center

Seoul, 07722

South Korea