A Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC)
Description
This is a randomized controlled trial to compare survival for patients undergoing robotic assisted laparoscopy versus open radical hysterectomy and lymph node assessment for the treatment of early-stage cervical cancer.
Status
Accepting new patients
Primary Study Objective(s)
Survival
Core eligibility
Note: This is only a partial list of eligibility criteria.
Inclusion Criteria:
- 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 Criteria:
- 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.
