A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer | NCT04831580 | Trialant

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer | NCT04831580 | Trialant

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

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Eligibility Criteria: 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:

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.

Exclusion Criteria:

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.

Western Regional Medical Center LLCWithdrawn

Goodyear, Arizona 85338, United States

City of HopeRecruiting

Duarte, California 91010, United States

Raechelle TinsleyContact

RTinsley@coh.org

Mihae Song, MDPrincipal Investigator

University of California San Diego Medical CenterRecruiting

Encinitas, California 92024, United States

City of Hope Orange County Lennar Foundation CancerRecruiting

Irvine, California 92618, United States

University of California San Diego Medical CenterRecruiting

La Jolla, California 92037, United States

University of California San Diego Moores Cancer CenterRecruiting

La Jolla, California 92093, United States

UCLA Gynecologic Oncology ClinicRecruiting

Los Angeles, California 90095, United States

Hoag Gynecologic OncologyRecruiting

Newport Beach, California 92633, United States

Hoag Memorial Hospital PresbyterianRecruiting

Newport Beach, California 92663, United States

Palo Alto Medical FoundationWithdrawn

Palo Alto, California 94040, United States

Stanford HospitalRecruiting

Palo Alto, California 94305, United States

University of California San Diego Medical CenterRecruiting

San Diego, California 92103, United States

California Pacific Medical Center-Research InstituteWithdrawn

San Francisco, California 91409, United States

City of Hope - UplandRecruiting

Upland, California 91786, United States

University of California San Diego Medical CenterRecruiting

Vista, California 92081, United States

Hartford HospitalRecruiting

Hartford, Connecticut 06102, United States

Hartford Healthcare Cancer Institute at Hartford HospitalRecruiting

Hartford, Connecticut 06106, United States

Hartford Healthcare Medical Group-ManchesterRecruiting

Manchester, Connecticut 06042, United States

Harford HealthCare Cancer Institute at the Hospital of Central ConnecticutRecruiting

New Britain, Connecticut 06053, United States

Ascension Medical Group St. Vincent's Obstetrics and GynecologyRecruiting

Jacksonville, Florida 32204, United States

Mercy HospitalRecruiting

Miami, Florida 33133, United States

Mount Sinai Comprehensive Cancer CenterWithdrawn

Miami, Florida 33140, United States

South Miami HospitalRecruiting

Miami, Florida 33143, United States

South Miami HospitalRecruiting

Miami, Florida 33143, United States

Mercy HospitalRecruiting

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 CenterWithdrawn

Orlando, Florida 32806, United States

Orlando Health Winnie Palmer Hospital for Woman and BabiesWithdrawn

Orlando, Florida 32806, United States

Tampa General HospitalWithdrawn

Tampa, Florida 33606, United States

Georgian Cancer Center at Augusta UniversityRecruiting

Augusta, Georgia 30912, United States

Southeastern Regional Medical Center LLCWithdrawn

Newnan, Georgia 30265, United States

St. Vincent Hospital and Health Care Center IncWithdrawn

Indianapolis, Indiana 46260, United States

St. Vincent Hospital and Health Care Center, IncWithdrawn

Indianapolis, Indiana 46260, United States

St. Elizabeth HealthcareActive, not recruiting

Edgewood, Kentucky 41017, United States

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Lexington, Kentucky 40503, United States

Baptist HealthRecruiting

Lexington, Kentucky 40503, United States

LSU Health New OrleansRecruiting

New Orleans, Louisiana 70112, United States

Willis-Knighton Physician Network Gynecologic Oncology AssociatesRecruiting

Shreveport, Louisiana 71118, United States

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

Scarborough, Maine 04074, United States

Baystate Medical CenterWithdrawn

Springfield, Massachusetts 01199, United States

Minnesota Oncology HematologyRecruiting

Minneapolis, Minnesota 55404, United States

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

Minneapolis, Minnesota 55455, United States

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

Minneapolis, Minnesota 55455, United States

David C. Pratt CenterRecruiting

St Louis, Missouri 63141, United States

Center of HopeRecruiting

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 CenterActive, not recruiting

Albuquerque, New Mexico 87131, United States

Northwell Health/South Shore University HospitalRecruiting

Bay Shore, New York 11706, United States

Northwell Health Physician Partners/Gynecological Oncology at BrightwatersRecruiting

Brightwaters, New York 11718, United States

Laura and Issac Perlmutter Cancer Center at NYU LangoneRecruiting

Brooklyn, New York 11220, United States

NYU Langone Ambulatory Care Bay RidgeRecruiting

Brooklyn, New York 11220, United States

NYU Langone Hospital-BrooklymRecruiting

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 HospitalRecruiting

Huntington, New York 11743, United States

Memorial Sloan Kettering (Monmouth)Recruiting

Middletown, New York 07748, United States

Northwell Health/Long Island Jewish Medical CenterRecruiting

New Hyde Park, New York 11040, United States

NHPP/Gynecologic Oncology at New Hyde ParkRecruiting

New Hyde Park, New York 11042, United States

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

New York, New York 10016, United States

Laura and Issac Perlmutter Cancer Center at NYU LangoneRecruiting

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 SinaiRecruiting

New York, New York 10029, United States

Josie Robertson Surgery CenterRecruiting

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 InstituteRecruiting

Charlotte, North Carolina 28204, United States

Duke University HospitalRecruiting

Durham, North Carolina 27705, United States

Duke Cancer CenterRecruiting

Durham, North Carolina 27710, United States

Duke Cancer CenterRecruiting

Durham, North Carolina 27710, United States

Novant Health Cancer InstituteRecruiting

Greensboro, North Carolina 27403, United States

Novant Health Cancer InstituteRecruiting

Kernersville, North Carolina 27284, United States

Novant Health Cancer InstituteRecruiting

Mount Airy, North Carolina 27030, United States

Novant Health Cancer InstituteRecruiting

North Wilkesboro, North Carolina 28659, United States

FirstHealth Outpatient Cancer CenterWithdrawn

Pinehurst, North Carolina 28374, United States

Novant Health Cancer InstituteRecruiting

Statesville, North Carolina 28625, United States

Novant Health Cancer InstituteRecruiting

Thomasville, North Carolina 27360, United States

Novant Health Cancer InstituteRecruiting

Winston-Salem, North Carolina 27103, United States

Summa Health Jean and Milton Copper PavilionRecruiting

Akron, Ohio 44304, United States

Summa Health Jean and Milton Copper PavillionRecruiting

Akron, Ohio 44304, United States

TriHealth Cancer Institute-Good Samaritan HospitalActive, not recruiting

Cincinnati, Ohio 45220, United States

TriHealth Cancer Institute-Thomas Comprehensive Care CenterActive, not recruiting

Cincinnati, Ohio 45220, United States

University of Cleveland Medical CenterRecruiting

Cleveland, Ohio 44106, United States

OSU Wexner Medical Center Hospital EastRecruiting

Columbus, Ohio 43203, United States

OSU Wexner Medical Center Outpatient Care EastRecruiting

Columbus, Ohio 43203, United States

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

Columbus, Ohio 43210, United States

OSU Wexner Medical Center University HospitalRecruiting

Columbus, Ohio 43210, United States

OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast CenterRecruiting

Columbus, Ohio 43212, United States

OSU Wexner Medical Center Martha Morehouse Outpatient CareRecruiting

Columbus, Ohio 43221, United States

OSU Wexner Medical Center Outpatient Care Upper ArlingtonRecruiting

Columbus, Ohio 43221, United States

OSU Wexner Medical Center Outpatient Care GahannaRecruiting

Columbus, Ohio 43230, United States

OSU Wexner Medical Center Outpatient Care DublinRecruiting

Dublin, Ohio 43016, United States

JamesCare Gynecologic Oncology at Mill RunRecruiting

Hilliard, Ohio 43026, United States

Kettering Health Cancer CenterRecruiting

Kettering, Ohio 45429, United States

OSU Wexner Medical Center Outpatient Care Lewis CenterRecruiting

Lewis Center, Ohio 43035, United States

OSU Wexner Medical Center Outpatient Care New AlbanyRecruiting

Westerville, Ohio 43081, United States

Stephenson Cancer CenterRecruiting

Oklahoma City, Oklahoma 73104, United States

Legacy Good Samaritan Medical Center-Gynecological Oncology GroupWithdrawn

Portland, Oregon 97210, United States

Providence Center Institute Franz ClinicRecruiting

Portland, Oregon 97213, United States

Legacy Meridian Park Medical Center-Legacy Medical Gynecologic OncologyWithdrawn

Tualatin, Oregon 97062, United States

Abington Memorial HospitalRecruiting

Abington, Pennsylvania 19001, United States

University of Pennsylvania Health System, Perelman Center for Advanced MedicineRecruiting

Philadelphia, Pennsylvania 19104, United States

Magee - Womens Hospital of UPMCRecruiting

Pittsburgh, Pennsylvania 15213, United States

AHN West Penn HospitalRecruiting

Pittsburgh, Pennsylvania 15224, United States

Asplundh Cancer PavillionRecruiting

Willow Grove, Pennsylvania 19090, United States

Alliance Cancer Specialists, PCRecruiting

Wynnewood, Pennsylvania 19096, United States

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

Providence, Rhode Island 02905, United States

Chattanooga's Program in Women's OncologyRecruiting

Chattanooga, Tennessee 37403, United States

The West Clinic, PLLC dba West Cancer CenterRecruiting

Germantown, Tennessee 38119, United States

Texas Oncology-AustinRecruiting

Austin, Texas 78758, United States

Texas Oncology- GYN ONC DFWWRecruiting

Bedford, Texas 76022, United States

Texas Oncology-DFWWRecruiting

Bedford, Texas 76022, United States

Texas Oncology- Baylor Charles A. Sammons Cancer CenterRecruiting

Dallas, Texas 75246, United States

University of Texas Southwestern Medical Center-Simmons Cancer CenterRecruiting

Dallas, Texas 75390, United States

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

Dallas, Texas 75390, United States

University of Texas Southwestern Medical Center-Zale Lipshy University HospitalRecruiting

Dallas, Texas 75390, United States

University of Texas Southwestern Medical CenterRecruiting

Dallas, Texas 75390, United States

Texas Oncology-GYN ONC DFWWRecruiting

Fort Worth, Texas 76104, United States

Texas OncologyRecruiting

Fort Worth, Texas 76104, United States

Texas Oncology-San AntonioRecruiting

San Antonio, Texas 78240, United States

Texas Oncology-The Woodlands, Gynecologic OncologyRecruiting

The Woodlands, Texas 77380, United States

University of Virginia Comprehensive Cancer CenterRecruiting

Charlottesville, Virginia 22903, United States

University of VirginiaRecruiting

Charlottesville, Virginia 22903, United States

Inova Health SystemRecruiting

Fairfax, Virginia 22031, United States

VCU Health at GreenGateRecruiting

Henrico, Virginia 23233, United States

VCU Health Emergency Center at New KentRecruiting

Quinton, Virginia 23141, United States

Virginia Commonwealth University Massey Cancer CenterRecruiting

Richmond, Virginia 23219, United States

VCU Health Short Pump PavillionRecruiting

Richmond, Virginia 23233, United States

VCU Massey Cancer Center at Stony PointRecruiting

Richmond, Virginia 23235, United States

Virginia Commonwealth University-Main HospitalRecruiting

Richmond, Virginia 23298, United States

VCU Health at Tappahannock HospitalActive, not recruiting

Tappahannock, Virginia 25560, United States

VCU Health-William and MaryRecruiting

Williamsburg, Virginia 23185, United States

Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic OncologyWithdrawn

Vancouver, Washington 98686, United States

West Virginia UniversityRecruiting

Morgantown, West Virginia 26506, United States

West VirginiaRecruiting

Morgantown, West Virginia 26506, United States

University of Wisconsin Clinical Science CenterRecruiting

Madison, Wisconsin 53792, United States

Hospital Erasto GaertnerRecruiting

Curitiba, Paraná 81520-060, Brazil

Hospital Municipal Vila Santa CatarinaRecruiting

São Paulo, Sao Paula 04378-500, Brazil

Barretos Cancer HospitalRecruiting

Barretos, São Paulo 14784-400, Brazil

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

São José do Rio Preto, São Paulo 15090-000, Brazil

A.C.Camargo Cancer CenterRecruiting

São Paulo, São Paulo 01509001, Brazil

Brazilian National Cancer InstituteRecruiting

Rio de Janeiro, 20081-250, Brazil

Princess Margaret Cancer CenterRecruiting

Toronto, Ontario M5G2M9, Canada

McGill University Health Centre-Glen SiteRecruiting

Montreal, Quebec H4A 3J1, Canada

Centre Hospitalier De L'Universite De MontrealRecruiting

Montreal, H2X 3E4, Canada

CHA Bundang Medical CenterRecruiting

Seongnam-si, Gyeonggi-do 13496, South Korea

Seoul National University Bundang HospitalRecruiting

Seongnam-si, Gyeonggi-do 13620, South Korea

Gangnam Severance HospitalRecruiting

Seoul, Republic of Korea 06273, South Korea

Severance Hospital - Yonsei Cancer CenterRecruiting

Seoul, Republic of Korea 07722, South Korea

Korea University Guro HospitalRecruiting

Seoul, Republic of Korea 08308, South Korea

Korea University Anam HospitalRecruiting

Seoul, 02843, South Korea

Asan Medical CenterRecruiting

Seoul, 05505, South Korea

Samsung Medical CenterRecruiting

Seoul, 06351, South Korea

Seoul St. Mary's Hospital - Catholic UniversityRecruiting

Seoul, 06591, South Korea

Severance Hospital - Yonsei Cancer CenterRecruiting

Seoul, 07722, South Korea