ROCC/GOG-3043: a randomized controlled trial of robotic versus open surgery for early-stage cervical cancer.
Mario M Leitao, Kristin L Bixel, Dana Meredith Chase...
https://pubmed.ncbi.nlm.nih.gov/40188007Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID04831580
A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer (ROCC)
Led by GOG Foundation · Updated on 2024-12-19
840
Participants Needed
136
Research Sites
52 weeks
Total Duration
On this page
Sponsors
G
GOG Foundation
Lead Sponsor
I
Intuitive Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating survival outcomes for patients with early stage cervical cancer undergoing either robotic-assisted laparoscopy or open hysterectomy with lymph node assessment. This multi-center, randomized trial tests the hypothesis that robotic hysterectomy with tumor containment before colpotomy is not inferior to abdominal hysterectomy regarding disease-free survival. The study focuses on patients with specific cervical cancer stages and tumor sizes, aiming to compare surgical approaches. Participants are randomly assigned to one of two groups: the standard open surgery group performing radical or simple hysterectomy using established techniques with vaginal closure over the tumor before colpotomy, and the robotic surgery group using minimally invasive robotic-assisted hysterectomy with vaginal closure prior to intracorporeal colpotomy. Surgeons perform thorough intraoperative assessments for metastatic disease, and certain patients with confirmed metastases are excluded from final analysis. Detailed surgical data and complications are recorded for all cases. During the study, participants will undergo preoperative assessments, surgery, and follow-up evaluations. Researchers will monitor survival over 36 months as the primary outcome, documenting operative time, findings, blood loss, and complications. Patients will be followed to assess disease-free survival, with attention to surgical outcomes and safety. The total duration of participation includes the surgery and long-term survival monitoring to compare the effectiveness of the two surgical methods.
CONDITIONS
Brief Title
A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, or adenosquamous carcinoma (including glassy cell)
- Patient must be FIGO Stage IA2, IB1, or IB2 (2018 staging) without evidence of parametrial, vaginal, nodal, or distant metastases on exam or imaging
- Tumor size must be 4 cm or less confirmed by MRI prior to randomization
- Uterine size less than 12 cm and suitable for vaginal specimen delivery
- Suitable surgical candidate with preoperative labs and EKG per institutional standards
- Patient must be age 18 years or older
- ECOG performance status 0-1
- Negative urine pregnancy test within 30 days of surgery in pre-menopausal women
- Signed informed consent and authorization for personal health information release
You will not qualify if you...
- Tumor histology other than those listed, including neuroendocrine and certain adenocarcinoma types (gastric, endometrioid, clear cell, serous, signet ring, minimal deviation)
- FIGO stage 1A1, IB3, II-IV (2018 staging)
- Inability to receive MRI
- Tumor size greater than 4 cm or evidence of vaginal/parametrial involvement on MRI or clinical exam
- Evidence of metastatic disease or positive lymph nodes
- History of prior pelvic or abdominal radiotherapy
- Prior malignancy within 5 years except non-melanoma skin cancer
- Inability to tolerate prolonged lithotomy or steep Trendelenburg position
- Compliance or geographic issues preventing adequate follow-up
- Poorly controlled HIV with CD4 count less than 500
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery and immediate recovery period
Participants undergo either robotic-assisted or open radical or simple hysterectomy surgery with tumor containment prior to colpotomy. Surgeons document operative details including operative time, findings, complications, and blood loss. Intraoperative decisions may affect surgery continuation.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 36 months
Participants are monitored after surgery for recovery and outcomes related to treatment.
Regular follow-up visits over 36 months
Trial Site Locations
Total: 136 locations
1
Western Regional Medical Center LLC
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
University of California San Diego Medical Center
Encinitas, California, United States, 92024
Actively Recruiting
4
City of Hope Orange County Lennar Foundation Cancer
Irvine, California, United States, 92618
Actively Recruiting
5
University of California San Diego Medical Center
La Jolla, California, United States, 92037
Actively Recruiting
6
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
7
Hoag Gynecologic Oncology
Newport Beach, California, United States, 92633
Actively Recruiting
8
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
9
Palo Alto Medical Foundation
Palo Alto, California, United States, 94040
Actively Recruiting
10
Stanford Hospital
Palo Alto, California, United States, 94305
Actively Recruiting
11
University of California San Diego Medical Center
San Diego, California, United States, 92103
Actively Recruiting
12
California Pacific Medical Center-Research Institute
San Francisco, California, United States, 91409
Actively Recruiting
13
City of Hope - Upland
Upland, California, United States, 91786
Actively Recruiting
14
University of California San Diego Medical Center
Vista, California, United States, 92081
Actively Recruiting
15
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut, United States, 06106
Actively Recruiting
16
Hartford Hospital
Hatford, Connecticut, United States, 06102
Actively Recruiting
17
Hartford Healthcare Medical Group-Manchester
Manchester, Connecticut, United States, 06042
Actively Recruiting
18
Harford HealthCare Cancer Institute at the Hospital of Central Connecticut
New Britain, Connecticut, United States, 06053
Actively Recruiting
19
Ascension Medical Group St. Vincent's Obstetrics and Gynecology
Jacksonville, Florida, United States, 32204
Actively Recruiting
20
Mercy Hospital
Miami, Florida, United States, 33133
Actively Recruiting
21
Mount Sinai Comprehensive Cancer Center
Miami, Florida, United States, 33140
Withdrawn
22
South Miami Hospital
Miami, Florida, United States, 33143
Actively Recruiting
23
South Miami Hospital
Miami, Florida, United States, 33143
Actively Recruiting
24
Mercy Hospital
Miami, Florida, United States, 33173
Actively Recruiting
25
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
26
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
27
Orlando Health Cancer Center
Orlando, Florida, United States, 32806
Withdrawn
28
Orlando Health Winnie Palmer Hospital for Woman and Babies
Orlando, Florida, United States, 32806
Actively Recruiting
29
Tampa General Hospital
Tampa, Florida, United States, 33606
Withdrawn
30
Georgian Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
31
Southeastern Regional Medical Center LLC
Newnan, Georgia, United States, 30265
Actively Recruiting
32
St. Vincent Hospital and Health Care Center Inc
Indianapolis, Indiana, United States, 46260
Withdrawn
33
St. Vincent Hospital and Health Care Center, Inc
Indianapolis, Indiana, United States, 46260
Withdrawn
34
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Actively Recruiting
35
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Actively Recruiting
36
Baptist Health
Lexington, Kentucky, United States, 40503
Actively Recruiting
37
LSU Health New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
38
Willis-Knighton Physician Network Gynecologic Oncology Associates
Shreveport, Louisiana, United States, 71118
Actively Recruiting
39
Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology
Scarborough, Maine, United States, 04074
Actively Recruiting
40
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Withdrawn
41
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
42
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
43
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
44
David C. Pratt Center
St Louis, Missouri, United States, 63141
Actively Recruiting
45
Center of Hope
Reno, Nevada, United States, 89511
Actively Recruiting
46
Memorial Sloan Kettering (Basking Ridge)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
47
Memorial Sloan Kettering (Bergen)
Montvale, New Jersey, United States, 07645
Actively Recruiting
48
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
49
Northwell Health/South Shore University Hospital
Bay Shore, New York, United States, 11706
Actively Recruiting
50
Northwell Health Physician Partners/Gynecological Oncology at Brightwaters
Brightwaters, New York, United States, 11718
Actively Recruiting
51
Laura and Issac Perlmutter Cancer Center at NYU Langone
Brooklyn, New York, United States, 11220
Actively Recruiting
52
NYU Langone Ambulatory Care Bay Ridge
Brooklyn, New York, United States, 11220
Actively Recruiting
53
NYU Langone Hospital-Brooklym
Brooklyn, New York, United States, 11220
Actively Recruiting
54
Memorial Sloan Kettering (Commack)
Commack, New York, United States, 11725
Actively Recruiting
55
Memorial Sloan Kettering (Westchester)
Harrison, New York, United States, 10604
Actively Recruiting
56
Northwell Health/Huntington Hospital
Huntington, New York, United States, 11743
Actively Recruiting
57
Memorial Sloan Kettering (Monmouth)
Middletown, New York, United States, 07748
Actively Recruiting
58
Northwell Health/Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
59
NHPP/Gynecologic Oncology at New Hyde Park
New Hyde Park, New York, United States, 11042
Actively Recruiting
60
Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street
New York, New York, United States, 10016
Actively Recruiting
61
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
62
NYU Langone Medical Center (Tisch Hospital)
New York, New York, United States, 10016
Actively Recruiting
63
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
64
Josie Robertson Surgery Center
New York, New York, United States, 10065
Actively Recruiting
65
Memorial Sloan Kettering Cancer Center (Main Campus)
New York, New York, United States, 10065
Actively Recruiting
66
Memorial Sloan Kettering (Nassau)
Uniondale, New York, United States, 11553
Actively Recruiting
67
Novant Health Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
68
Duke University Hospital
Durham, North Carolina, United States, 27705
Actively Recruiting
69
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
70
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
71
Novant Health Cancer Institute
Greensboro, North Carolina, United States, 27403
Actively Recruiting
72
Novant Health Cancer Institute
Kernersville, North Carolina, United States, 27284
Actively Recruiting
73
Novant Health Cancer Institute
Mount Airy, North Carolina, United States, 27030
Actively Recruiting
74
Novant Health Cancer Institute
North Wilkesboro, North Carolina, United States, 28659
Actively Recruiting
75
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
76
Novant Health Cancer Institute
Statesville, North Carolina, United States, 28625
Actively Recruiting
77
Novant Health Cancer Institute
Thomasville, North Carolina, United States, 27360
Actively Recruiting
78
Novant Health Cancer Institute
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
79
Summa Health Jean and Milton Copper Pavilion
Akron, Ohio, United States, 44304
Actively Recruiting
80
Summa Health Jean and Milton Copper Pavillion
Akron, Ohio, United States, 44304
Actively Recruiting
81
TriHealth Cancer Institute-Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Actively Recruiting
82
TriHealth Cancer Institute-Thomas Comprehensive Care Center
Cincinnati, Ohio, United States, 45220
Actively Recruiting
83
University of Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
84
OSU Wexner Medical Center Hospital East
Columbus, Ohio, United States, 43203
Actively Recruiting
85
OSU Wexner Medical Center Outpatient Care East
Columbus, Ohio, United States, 43203
Actively Recruiting
86
James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
87
OSU Wexner Medical Center University Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
88
OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212
Actively Recruiting
89
OSU Wexner Medical Center Martha Morehouse Outpatient Care
Columbus, Ohio, United States, 43221
Actively Recruiting
90
OSU Wexner Medical Center Outpatient Care Upper Arlington
Columbus, Ohio, United States, 43221
Actively Recruiting
91
OSU Wexner Medical Center Outpatient Care Gahanna
Columbus, Ohio, United States, 43230
Actively Recruiting
92
OSU Wexner Medical Center Outpatient Care Dublin
Dublin, Ohio, United States, 43016
Actively Recruiting
93
JamesCare Gynecologic Oncology at Mill Run
Hilliard, Ohio, United States, 43026
Actively Recruiting
94
Kettering Health Cancer Center
Kettering, Ohio, United States, 45429
Actively Recruiting
95
OSU Wexner Medical Center Outpatient Care Lewis Center
Lewis Center, Ohio, United States, 43035
Actively Recruiting
96
OSU Wexner Medical Center Outpatient Care New Albany
Westerville, Ohio, United States, 43081
Actively Recruiting
97
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
98
Legacy Good Samaritan Medical Center-Gynecological Oncology Group
Portland, Oregon, United States, 97210
Withdrawn
99
Providence Center Institute Franz Clinic
Portland, Oregon, United States, 97213
Actively Recruiting
100
Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology
Tualatin, Oregon, United States, 97062
Withdrawn
101
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Actively Recruiting
102
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
103
Magee - Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
104
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
105
Asplundh Cancer Pavillion
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
106
Women's and Infants Hospital of Rhode Island Program in Women's Oncology
Providence, Rhode Island, United States, 02905
Actively Recruiting
107
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
108
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States, 38119
Actively Recruiting
109
Texas Oncology-Austin
Austin, Texas, United States, 78758
Actively Recruiting
110
Texas Oncology- GYN ONC DFWW
Bedford, Texas, United States, 76022
Actively Recruiting
111
Texas Oncology-DFWW
Bedford, Texas, United States, 76022
Actively Recruiting
112
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
113
University of Texas Southwestern Medical Center-Simmons Cancer Center
Dallas, Texas, United States, 75390
Actively Recruiting
114
University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital
Dallas, Texas, United States, 75390
Actively Recruiting
115
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
Dallas, Texas, United States, 75390
Actively Recruiting
116
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
117
Texas Oncology-GYN ONC DFWW
Fort Worth, Texas, United States, 76104
Actively Recruiting
118
Texas Oncology
Fort Worth, Texas, United States, 76104
Actively Recruiting
119
Texas Oncology-San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
120
Texas Oncology-The Woodlands, Gynecologic Oncology
The Woodlands, Texas, United States, 77380
Actively Recruiting
121
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
122
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
123
VCU Health at GreenGate
Henrico, Virginia, United States, 23233
Actively Recruiting
124
VCU Health Emergency Center at New Kent
Quinton, Virginia, United States, 23141
Actively Recruiting
125
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23219
Actively Recruiting
126
VCU Health Short Pump Pavillion
Richmond, Virginia, United States, 23233
Actively Recruiting
127
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
128
Virginia Commonwealth University-Main Hospital
Richmond, Virginia, United States, 23298
Actively Recruiting
129
VCU Health at Tappahannock Hospital
Tappahannock, Virginia, United States, 25560
Actively Recruiting
130
VCU Health-William and Mary
Williamsburg, Virginia, United States, 23185
Actively Recruiting
131
Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology
Vancouver, Washington, United States, 98686
Actively Recruiting
132
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
133
West Virginia
Morgantown, West Virginia, United States, 26506
Actively Recruiting
134
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
135
McGill University Health Centre-Glen Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
136
Centre Hospitalier De L'Universite De Montreal
Montreal, Canada, H2X 3E4
Actively Recruiting
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Research Team
J
Jennifer Klein, MEd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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Michelle Boisen, Richard Guido
https://pubmed.ncbi.nlm.nih.gov/37650664