ROCC/GOG-3043: A randomized controlled trial of robotic versus open surgery for early-stage cervical cancer
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 noninferiority trial of minimally invasive surgery vs an open approach in patients undergoing radical hysterectomy for early-stage cervical cancer did not meet its primary endpoint of 4.5-year disease-free survival and was terminated early due to 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 noninferior after robotic-assisted vs abdominal radical or simple hysterectomy. Trial Design: This multicenter, randomized noninferiority trial conducted through the Gynecologic Oncology Group has specified surgeon qualification criteria. It requires a pelvic magnetic resonance imaging (MRI) scan in all patients prior to 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 transcervical uterine manipulators. Major Inclusion/Exclusion Criteria: Patients with early-stage (2018 International Federation of Gynecology and Obstetrics stages…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 840 participants or records.
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