A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
This is a Phase III randomized controlled trial to compare survival for patients who undergi
 robotic assisted laparoscopy versus open radical hysterectomy and lymph node assessment for
 the treatment of early stage cervical cancer.
This is a phase III, multi-center, open-label, randomized, non-inferiority clinical trial
 with the hypothesis that robotically assisted radical hysterectomy with tumor containment
 prior to colpotomy is non-inferior to abdominal radical hysterectomy with respect to disease
 free survival.

 A t 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 radical 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 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 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)
Inclusion Criteria:

 1. Histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma,
 adenosquamous carcinoma (Including glassy cell)

 2. FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial,
 vaginal, nodal or distant metastases on exam or imaging.

 3. Uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen

 4. Suitable surgical candidate

 5. Age 18 years or older

 6. ECOG performance status 0-1

 7. Adequate bone marrow, renal and hepatic function

 8. Negative urine pregnancy test within 30 days of surgery in pre-menopausal women or
 those <2 years after onset of menopause

 9. Prior malignancy allowed if >5 years since diagnosis without evidence of disease

 Exclusion Criteria:

 1. Any tumor histology other than those listed above

 2. FIGO stage 1A1, IB3, II-IV (2018 staging)

 3. Inability to have an MRI

 4. Tumor size ≥4cm or evidence of definitive vaginal/parametrial involvement on pelvic
 exam or MRI

 5. Uterine size >12cm or clinical suspicion that the uterus will not be able to be
 removed vaginally.

 6. Evidence of metastatic disease (imaging or histologically positive lymph nodes)

 7. History of prior pelvic or abdominal radiotherapy

 8. Prior malignancy within 5 years

 9. Unable to withstand prolonged lithotomy or steep trendelenberg

 10. Patient compliance and geographic proximity that do not allow adequate follow-up

 11. Poorly controlled HIV defined as CD4 count <500