RECRUITING

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

Talk to us

Conditions

Cervical Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-22
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04831580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
  2. 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. 3. Patient must have uterine size \<12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.
  4. 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.
  5. 1. pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND
  6. 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.
  7. 5. Patient must be age 18 years or older.
  8. 6. Patient must have ECOG performance status 0-1.
  9. 7. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.
  10. 8. Patient must have signed an approved informed consent and authorization permitting the release of personal health information.
  1. 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. 2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
  3. 3. Patient with inability to receive an MRI.
  4. 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. 5. Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
  6. 6. Patients with a history of prior pelvic or abdominal radiotherapy.
  7. 7. Patients with a prior malignancy \< 5 years from enrollment with the exception of non-melanoma skin cancer.
  8. 8. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
  9. 9. Patient compliance and geographic proximity that do not allow adequate follow-up.
  10. 10. Patients with poorly controlled HIV with CD4 counts \<500.

Contacts and Locations

Study Contact

Jennifer Klein, MEd
CONTACT
215-854-0770
jklein@gog.org

Principal Investigator

Kristin Bixel, MD
STUDY_CHAIR
Standford University

Study Locations (Sites)

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
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
Mercy Hospital
Miami, Florida, 33173
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
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
Saint 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
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
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
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

Collaborators and Investigators

Sponsor: GOG Foundation

  • Kristin Bixel, MD, STUDY_CHAIR, Standford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-22
Study Completion Date2029-08

Study Record Updates

Study Start Date2022-03-22
Study Completion Date2029-08

Terms related to this study

Additional Relevant MeSH Terms

  • Cervical Cancer