ROCC/GOG-3043: a randomized controlled trial of robotic versus open surgery for early-stage cervical cancer

Mario M Leitao Jr; Kristin L Bixel; Dana Meredith Chase; Allison Quick; Colleen McCormick; Destin Black; Peter C Lim; Ramez N Eskander; Walter H Gotlieb; Salvatore LoCoco; Martin A Martino; Joan L Walker; Larry J Copeland; Bradley J Monk; Leslie M Randall

doi:10.1016/j.ijgc.2025.101760

ROCC/GOG-3043: a randomized controlled trial of robotic versus open surgery for early-stage cervical cancer

Int J Gynecol Cancer. 2025 Feb 28:101760. doi: 10.1016/j.ijgc.2025.101760. Online ahead of print.

Authors

Affiliations

¹ Gynecology 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.
² Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Stanford University, Palo Alto, CA, USA.
³ Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, David Geffen School of Medicine at UCLA Health, Los Angeles, CA, USA.
⁴ Department of Radiation Oncology, Ohio State University, James Cancer Center, Columbus, OH, USA.
⁵ The University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.
⁶ Department of Obstetrics & Gynecology, Willis-Knighton Physicians Network and Louisiana State University Health, Shreveport, LA, USA; Trials365, LLC, Shreveport, LA, USA.
⁷ Center of Hope, Reno, NV, USA.
⁸ Department 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.
⁹ Division of Gynecologic Oncology, McGill University - Jewish General Hospital, Montreal, Canada.
¹⁰ Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
¹¹ Department of Gynecologic Oncology and Women's Health, Ascension St. Vincent's, Jacksonville, FL, USA.
¹² Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
¹³ Department of Obstetrics & Gynecology, Division of Gynecologic Oncology, Ohio State University, James Cancer Center, Columbus, OH, USA.
¹⁴ Division of Gynecologic Oncology, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ, USA.
¹⁵ Gynecologic Cancer Service Line, Inova Schar Cancer Center, Inova Health System, Fairfax, VA, USA.

PMID: 40188007
DOI: 10.1016/j.ijgc.2025.101760

Abstract

Background: The 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 objective: Our 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 design: This 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 results: 2030.

Trial registration: ClinicalTrials.gov identifier: NCT04831580.

Keywords: Cervical Cancer; Radical Hysterectomy; Robotic-Assisted Surgery; Simple Hysterectomy.

Associated data

ClinicalTrials.gov/NCT04831580