Clinical trial NCT04831580: A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
Official title: A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer (ROCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: Intuitive Foundation
First posted: 2021-04-05
Enrollment: 840
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

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