A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
Recruiting now · Not applicable
Conditions studied: Cervical Cancer
In brief
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.
Key facts
- Study ID
- NCT04831580
- Run by
- GOG Foundation
- People needed
- 840
- Starts
- 2022-03-22
- Expected to finish
- 2030-03-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 greater than 4cm or 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).
- 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.
Where it is running
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (enrolling)
- Georgian Cancer Center at Augusta University — Augusta, Georgia, United States (enrolling)
- City of Hope Orange County Lennar Foundation Cancer — Irvine, California, United States (enrolling)
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (enrolling)
- University of California San Diego Medical Center — Encinitas, California, United States (enrolling)
- UCLA Gynecologic Oncology Clinic — Los Angeles, California, United States (enrolling)
- Hoag Gynecologic Oncology — Newport Beach, California, United States (enrolling)
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
- University of California San Diego Medical Center — La Jolla, California, United States (enrolling)
- City of Hope — Duarte, California, United States (enrolling)
- University of California San Diego Medical Center — San Diego, California, United States (enrolling)
- University of California San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
- City of Hope - Upland — Upland, California, United States (enrolling)
- University of California San Diego Medical Center — Vista, California, United States (enrolling)
- Hartford Hospital — Hartford, Connecticut, United States (enrolling)
- Hartford Healthcare Cancer Institute at Hartford Hospital — Hartford, Connecticut, United States (enrolling)
- Hartford Healthcare Medical Group-Manchester — Manchester, Connecticut, United States (enrolling)
- Harford HealthCare Cancer Institute at the Hospital of Central Connecticut — New Britain, Connecticut, United States (enrolling)
- Ascension Medical Group St. Vincent's Obstetrics and Gynecology — Jacksonville, Florida, United States (enrolling)
- Mercy Hospital — Miami, Florida, United States (enrolling)
- Stanford Hospital — Palo Alto, California, United States (enrolling)
- South Miami Hospital — Miami, Florida, United States (enrolling)
- South Miami Hospital — Miami, Florida, United States (enrolling)
- Mercy Hospital — Miami, Florida, United States (enrolling)
- Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)
Full record on ClinicalTrials.gov
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