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Cancer

Recruiting

Baptist Health Lexington

Hope McClaine Cottrill

Principal Investigator

Lauren Higgins

Coordinator

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Overview

GOG-3043: A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial)
Description

This is a randomized controlled trial to compare survival for patients who undergo robotic assisted laparoscopy versus open radical hysterectomy and lymph node assessment for the treatment of early stage cervical cancer.

Learn more at clinicaltrials.gov
Eligibility Criteria

Inclusion

  • 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.
  • 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.
  • 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.

Exclusion

  • Patients with any 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)
  • Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
  • Patient with inability to receive an MRI.
  • Patients with a tumor size ≥4cm or with definite evidence of vaginal/parametrial involvement on MRI (if MRI findings are not definitive, then clinical examination must also reveal parametrial or vaginal extension).
  • Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
  • Patients with a history of prior pelvic or abdominal radiotherapy.
  • Patients with a prior malignancy < 5 years from enrollment with the exception of non-melanoma skin cancer.
  • Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
  • Patient compliance and geographic proximity that do not allow adequate follow-up.
  • Patients with poorly controlled HIV with CD4 counts <500.