Abstract
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.
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.
We hypothesize that disease-free survival is noninferior after robotic-assisted vs abdominal radical or simple hysterectomy.
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.
Patients with early-stage (2018 International Federation of Gynecology and Obstetrics stages IA2-IB2) cervical cancer. Histological types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Pelvic MRI must confirm a tumor that is 4 cm or less without definitive extracervical spread. A simple hysterectomy is allowed in select cases after trial study principal investigator review.
The primary endpoint is the 3-year disease-free survival between robotic-assisted or abdominal hysterectomy.
The trial will randomize 840 patients, with planned interim analysis for futility (oncologic safety) after we have randomized 370 and 640 patients.
2030
ClinicalTrials.gov identifier: NCT04831580.