Evidence map›Paper›PMID 40188007›Full record

ArticleInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2025

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, Allison Quick, Colleen McCormick, Destin Black, Peter C Lim, Ramez N Eskander, Walter H Gotlieb, Salvatore LoCoco and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04831580 (A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04831580 narecruitingnot on this map

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

TypeinterventionalSponsorGOG FoundationRan2022 to 2030Enrolled840ConditionsCervical CancerArmsda Vinci, open surgery
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Mario M LeitaoGynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of OB/GYN, Weill Cornell Medical College of Cornell University, New York, NY, USA. Electronic address: leitaom@mskcc.org.
Kristin L BixelDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, Stanford University, Palo Alto, CA, USA.
Dana Meredith ChaseDepartment of Obstetrics and Gynecology, Division of Gynecologic Oncology, David Geffen School of Medicine at UCLA Health, Los Angeles, CA, USA.
Allison QuickDepartment of Radiation Oncology, Ohio State University, James Cancer Center, Columbus, OH, USA.
Colleen McCormickThe University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.
Destin BlackDepartment of Obstetrics & Gynecology, Willis-Knighton Physicians Network and Louisiana State University Health, Shreveport, LA, USA; Trials365, LLC, Shreveport, LA, USA.
Peter C LimCenter of Hope, Reno, NV, USA.
Ramez N EskanderDepartment of Obstetrics, Gynecology and Reproductive Sciences, Division of Gynecologic Oncology, University of California San Diego, Rebecca and John Moores Cancer Center, La Jolla, CA, USA.
Walter H GotliebDivision of Gynecologic Oncology, McGill University - Jewish General Hospital, Montreal, Canada.
Salvatore LoCocoDepartment of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Martin A MartinoDepartment of Gynecologic Oncology and Women's Health, Ascension St. Vincent's, Jacksonville, FL, USA.
Joan L WalkerStephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Larry J CopelandDepartment of Obstetrics & Gynecology, Division of Gynecologic Oncology, Ohio State University, James Cancer Center, Columbus, OH, USA.
Bradley J MonkDivision of Gynecologic Oncology, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ, USA.
Leslie M RandallGynecologic Cancer Service Line, Inova Schar Cancer Center, Inova Health System, Fairfax, VA, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe Laparoscopic Approach to Cervical Cancer trial is the only randomized trial to date addressing the role of surgical approach in cervical cancer; however, this non-inferiority trial of minimally invasive surgery vs an open approach in patients undergoing radical hysterectomy for early-stage cervical cancer did not meet its primary end point of 4.5-year disease-free survival and was terminated early because of significantly worse disease-specific survival, overall survival, and locoregional recurrence in the minimally invasive surgery cohort. PRIMARY

objectiveOur trial compares 3-year disease-free survival after robotic-assisted or abdominal radical or simple (in select cases) hysterectomy in early-stage cervical cancer. STUDY HYPOTHESIS: We hypothesize that disease-free survival is non-inferior after robotic-assisted vs abdominal radical or simple hysterectomy. TRIAL

designThis multi-center, randomized non-inferiority trial conducted through the Gynecologic Oncology Group has specified surgeon qualification criteria. It requires a pelvic magnetic resonance imaging scan in all patients before enrollment and will use 1:1 randomization to assign patients to robotic-assisted or abdominal hysterectomy. All surgeons must use specified tumor-containment techniques in both arms. It does not allow trans-cervical uterine manipulators. MAJOR INCLUSION/EXCLUSION CRITERIA: Patients with early-stage (2018 International Federation of Gynecology and Obstetrics stages IA2-IB2) cervical cancer. Histologic types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Pelvic magnetic resonance imaging must confirm a tumor that is 4 cm or less without definitive extra-cervical spread. A simple hysterectomy is allowed in select cases after trial study principal investigator review. PRIMARY ENDPOINT: The primary end point is the 3-year disease-free survival between robotic-assisted or abdominal hysterectomy. SAMPLE SIZE: The trial will randomly allocate 840 patients, with planned interim analysis for futility (oncologic safety) after we have randomly allocated 370 and 640 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING

results2030.

trial registrationClinicalTrials.gov identifier: NCT04831580.

Indexed as

HysterectomyRobotic Surgical ProceduresUterine Cervical NeoplasmsAdultEquivalence Trials as TopicFemaleHumansMulticenter Studies as TopicNeoplasm StagingRandomized Controlled Trials as TopicCervical CancerRadical HysterectomyRobotic-Assisted SurgerySimple Hysterectomy

Identifiers

PMID40188007
PMCPMC13254790

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.