A Randomized Controlled Trial of Robotic versus Open Surgery for Early Stage Cervical Cancer (ROCC trial)

The purpose of this study is to investigate if minimally invasive surgery, called robotic assisted laparoscopy (small incision surgery), is better or worse than open surgery (otherwise known as a laparotomy) when performing a hysterectomy for cervical cancer.

For more information visit: https://clinicaltrials.gov/study/NCT04831580

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042

1. Patient must have histologically confirmed uterine cervical adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, or adenosquamous carcinoma (includes glassy cell).
2. Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) uterine cervical cancer without evidence ofdefinitive 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.
3. Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of specimen per investigator.
4. 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:
   1. pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND
   2. 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.
5. Patient must be age 18 years or older.
6. Patient must have ECOG performance status 0-1.
7. Patient must have signed an approved informed consent and authorization permitting the release of personal health information.

1. Patients with any uterine cervical cancer tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation).
2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
3. Patient with inability to obtain MRI.
4. Patients with tumor size greater than 4cm on MRI confirmed prior to randomization are excluded. Patients with definite evidence of vaginal/parametrial involvement on MRI are excluded; if MRI findings are not definitive, then clinical examination must also not reveal parametrial or vaginal extension.
5. Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
6. Patients with a history of prior pelvic or abdominal radiotherapy.
7. Patients with a prior malignancy within < 5 years from enrollment with the exception of nonmelanoma skin cancer.
8. Patients who are unable to withstand prolonged lithotomy or steep Trendelenberg.
9. Patient compliance and geographic proximity that do not allow adequate follow-up.
10. Patients with poorly controlled HIV with CD4 counts <500.