A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
18 Years and older, Male and Female
GOG-3043 (primary)
NCI-2022-02747
Summary
This is a randomized controlled trial to compare survival for patients who undergoe
robotic assisted laparoscopy versus open hysterectomy and lymph node assessment for the
treatment of early stage cervical cancer.
Objectives
This is a multi-center, open-label, randomized, non-inferiority clinical trial with the
hypothesis that robotically assisted hysterectomy with tumor containment prior to
colpotomy is non-inferior to abdominal hysterectomy with respect to disease free
survival.
At the commencement of surgery, a thorough inspection of all peritoneal surfaces should
be performed. The location of any suspected metastatic disease should be documented in
the operative report and a biopsy should be performed to confirm the diagnosis. If
intraperitoneal disease is detected, the radical hysterectomy should be abandoned. In
patients with macroscopic evidence of metastatic disease to the lymph nodes,
intraoperative frozen section should be performed to confirm the presence of metastatic
disease. Intraoperative management will be left to the discretion of the surgeon.
Patients who have confirmed macroscopic lymph node metastases intraoperatively will be
excluded from final analysis and replaced due to the controversy surrounding the decision
to perform a radical hysterectomy in this setting. Patients in whom the hysterectomy is
abandoned will be deemed non-evaluable and excluded from final analysis and will be
replaced. For all patients, the surgeon should document operative time from incision to
close, detailed description of operative findings, intraoperative complications, and
blood loss. For patients randomized to the robotic arm, the surgeon should document the
use of and specify the type of vaginal manipulator and the reason for conversion to
laparotomy (if applicable). Transcervical manipulators are not permitted.
Standard arm: Radical or simple hysterectomy is performed as per standard technique (peon
radical hysterectomy (Piver type 2 or 3 or Querleu & Morrow Type B or C) with
salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition.
Prior to colpotomy, the vagina must be closed over the tumor (ie, Wertheim clamps,
contour stapling device).
Study arm: Radical or simple hysterectomy is performed as per standard robotic technique
(Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be
removed or preserved +/- transposition. Colpotomy may be made intracorporally or
vaginally. Vagina must be closed prior to intracorporeal colpotomy (see below, #10)
Eligibility
- Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
- Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patients with tumor size less than or equal to 4 cm confirmed on MRI prior to randomization are eligible.
- Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.
- Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard and agree to be randomized to undergo open or robotic radical (or simple) hysterectomy. NOTE: Simple hysterectomy will be allowed in patients who meet the following criteria:
- pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND
- less than 50% stromal invasion on MRI if tumor present or less than 10 mm of stromal invasion if an excisional (cold knife or LEEP) has been performed. Submission of source documents in the GOG Partners Source Document Portal will be required prior to randomization for review and confirmation of simple hysterectomy being met (see Section 6.0 for instructions).
- Patient must be age 18 years or older.
- Patient must have ECOG performance status 0-1.
- Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.
- Patient must have signed an approved informed consent and authorization permitting the release of personal health information.
Treatment Sites in Georgia
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