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NCT04831580 Clinical Trial

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

Cervical Cancer Clinical Trial

— ROCC  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04831580
Other study ID # GOG-3043
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2022
Est. completion date August 2029

Study information
Verified date February 2024
Source GOG Foundation
Contact Jennifer Klein, MEd
Phone 215-854-0770
Email jklein@gog.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 840
Est. completion date August 2029
Est. primary completion date August 2028
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• da Vinci
Minimally invasive robotic-assisted surgical device
Other:
• open surgery
open radical hysterectomy

Locations
Country Name City State
Canada McGill University Health Centre-Glen Site Montréal Quebec
United States Abington Memorial Hospital Abington Pennsylvania
United States Summa Health Jean and Milton Copper Pavilion Akron Ohio
United States Summa Health Jean and Milton Copper Pavillion Akron Ohio
United States University of New Mexico Comprehensive Cancer Center Albuquerque New Mexico
United States Georgian Cancer Center at Augusta University Augusta Georgia
United States Texas Oncology-Austin Austin Texas
United States Memorial Sloan Kettering (Basking Ridge) Basking Ridge New Jersey
United States Northwell Health/South Shore University Hospital Bay Shore New York
United States Texas Oncology- GYN ONC DFWW Bedford Texas
United States Texas Oncology-DFWW Bedford Texas
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 Novant Health Cancer Institute Charlotte North Carolina
United States University of Virginia Charlottesville Virginia
United States University of Virginia Comprehensive Cancer Center Charlottesville Virginia
United States Chattanooga's Program in Women's Oncology Chattanooga Tennessee
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 James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus Ohio
United States OSU Wexner Medical Center Hospital East Columbus Ohio
United States OSU Wexner Medical Center Martha Morehouse Outpatient Care Columbus Ohio
United States OSU Wexner Medical Center Outpatient Care East Columbus Ohio
United States OSU Wexner Medical Center Outpatient Care Gahanna Columbus Ohio
United States OSU Wexner Medical Center Outpatient Care Upper Arlington Columbus Ohio
United States OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center Columbus Ohio
United States OSU Wexner Medical Center University Hospital Columbus Ohio
United States Memorial Sloan Kettering (Commack) Commack New York
United States Texas Oncology- Baylor Charles A. Sammons Cancer Center Dallas Texas
United States University of Texas Southwestern Medical 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 OSU Wexner Medical Center Outpatient Care Dublin Dublin Ohio
United States St. Elizabeth Healthcare Edgewood Kentucky
United States University of California San Diego Medical Center Encinitas California
United States Texas Oncology Fort Worth Texas
United States Texas Oncology-GYN ONC DFWW Fort Worth Texas
United States The West Clinic, PLLC dba West Cancer Center Germantown Tennessee
United States Western Regional Medical Center LLC Goodyear Arizona
United States Novant Health Cancer Institute Greensboro North Carolina
United States Memorial Sloan Kettering (Westchester) Harrison New York
United States Hartford Healthcare Cancer Institute at Hartford Hospital Hartford Connecticut
United States Hartford Hospital Hartford Connecticut
United States VCU Health at GreenGate Henrico Virginia
United States JamesCare Gynecologic Oncology at Mill Run Hilliard Ohio
United States Northwell Health/Huntington Hospital Huntington New York
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 Ascension Medical Group St. Vincent's Obstetrics and Gynecology Jacksonville Florida
United States Novant Health Cancer Institute Kernersville North Carolina
United States Kettering Health Cancer Center Kettering Ohio
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 OSU Wexner Medical Center Outpatient Care Lewis Center Lewis Center Ohio
United States Baptist Health Lexington Kentucky
United States Baptist Health Lexington Lexington Kentucky
United States University of Wisconsin Clinical Science Center Madison Wisconsin
United States Hartford Healthcare Medical Group-Manchester Manchester Connecticut
United States Mercy Hospital Miami Florida
United States Mercy Hospital Miami Florida
United States Mount Sinai Comprehensive Cancer Center Miami Florida
United States Memorial Sloan Kettering (Monmouth) Middletown New York
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 Memorial Sloan Kettering (Bergen) Montvale New Jersey
United States West Virginia Morgantown West Virginia
United States West Virginia University Morgantown West Virginia
United States Novant Health Cancer Institute Mount Airy North Carolina
United States Harford HealthCare Cancer Institute at the Hospital of Central Connecticut New Britain Connecticut
United States NHPP/Gynecologic Oncology at New Hyde Park New Hyde Park New York
United States Northwell Health/Long Island Jewish Medical Center New Hyde Park New York
United States LSU Health New Orleans New Orleans Louisiana
United States Josie Robertson Surgery Center New York New York
United States Laura and Issac Perlmutter Cancer Center at NYU Langone New York New York
United States Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street New York New York
United States Memorial Sloan Kettering Cancer Center (Main Campus) 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 Southeastern Regional Medical Center LLC Newnan Georgia
United States Hoag Gynecologic Oncology Newport Beach California
United States Hoag Memorial Hospital Presbyterian Newport Beach California
United States Novant Health Cancer Institute North Wilkesboro North Carolina
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Orlando Health Cancer Center Orlando Florida
United States Orlando Health Winnie Palmer Hospital for Woman and Babies Orlando Florida
United States Palo Alto Medical Foundation Palo Alto California
United States University of Pennsylvania Health System, Perelman Center for Advanced Medicine Philadelphia Pennsylvania
United States FirstHealth Outpatient Cancer Center Pinehurst North Carolina
United States AHN West Penn Hospital Pittsburgh Pennsylvania
United States Magee - Womens Hospital of UPMC Pittsburgh Pennsylvania
United States Legacy Good Samaritan Medical Center-Gynecological Oncology Group Portland Oregon
United States Women's and Infants Hospital of Rhode Island Program in Women's Oncology Providence Rhode Island
United States VCU Health Emergency Center at New Kent Quinton Virginia
United States Center of Hope Reno Nevada
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 Massey Cancer Center Richmond Virginia
United States Virginia Commonwealth University-Main Hospital Richmond Virginia
United States David C. Pratt Center Saint Louis Missouri
United States Texas Oncology-San Antonio San Antonio Texas
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 Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology Scarborough Maine
United States Willis-Knighton Physician Network Gynecologic Oncology Associates Shreveport Louisiana
United States Baystate Medical Center Springfield Massachusetts
United States Novant Health Cancer Institute Statesville North Carolina
United States Tampa General Hospital Tampa Florida
United States VCU Health at Tappahannock Hospital Tappahannock Virginia
United States Texas Oncology-The Woodlands, Gynecologic Oncology The Woodlands Texas
United States Novant Health Cancer Institute Thomasville North Carolina
United States Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology Tualatin Oregon
United States Memorial Sloan Kettering (Nassau) Uniondale New York
United States Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology Vancouver Washington
United States University of California San Diego Medical Center Vista California
United States OSU Wexner Medical Center Outpatient Care New Albany Westerville Ohio
United States VCU Health-William and Mary Williamsburg Virginia
United States Asplundh Cancer Pavillion Willow Grove Pennsylvania
United States Novant Health Cancer Institute Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
GOG Foundation Intuitive Foundation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival 3 year disease-free survival 36 months
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