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Clinical Trials in Brazil / NCT04831580
Recruiting Not applicable

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

NCT04831580 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2022-03-22
Last updated
2026-07-30

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

da Vinciopen surgery

da Vinci: Minimally invasive robotic-assisted radical or simple hysterectomy

open surgery: open radical or simple hysterectomy

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell) 2. 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. 3. Patient must have uterine size \<12 cm AND felt to be appropriate for vaginal delivery of the 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. 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). 5. Patient must be age 18 years or older. 6. Patient must have ECOG performance status 0-1. 7. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women. 8. Patient must have signed an approved informed consent and authorization permitting the release of personal health information. Exclusion Criteria: 1. 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) 2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging). 3. Patient with inability to receive an MRI. 4. 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). 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 \< 5 years from enrollment with the exception of non-melanoma 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.

Primary outcome measure(s)

Trial sites (156)

FacilityCityRegionStatus
Western Regional Medical Center LLC Goodyear Arizona Withdrawn
City of Hope Duarte California Recruiting
University of California San Diego Medical Center Encinitas California Recruiting
City of Hope Orange County Lennar Foundation Cancer Irvine California Recruiting
University of California San Diego Medical Center La Jolla California Recruiting
University of California San Diego Moores Cancer Center La Jolla California Recruiting
UCLA Gynecologic Oncology Clinic Los Angeles California Recruiting
Hoag Gynecologic Oncology Newport Beach California Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Palo Alto Medical Foundation Palo Alto California Withdrawn
Stanford Hospital Palo Alto California Recruiting
University of California San Diego Medical Center San Diego California Recruiting
California Pacific Medical Center-Research Institute San Francisco California Withdrawn
City of Hope - Upland Upland California Recruiting
University of California San Diego Medical Center Vista California Recruiting
Hartford Hospital Hartford Connecticut Recruiting
Hartford Healthcare Cancer Institute at Hartford Hospital Hartford Connecticut Recruiting
Hartford Healthcare Medical Group-Manchester Manchester Connecticut Recruiting
Harford HealthCare Cancer Institute at the Hospital of Central Connecticut New Britain Connecticut Recruiting
Ascension Medical Group St. Vincent's Obstetrics and Gynecology Jacksonville Florida Recruiting
Mercy Hospital Miami Florida Recruiting
Mount Sinai Comprehensive Cancer Center Miami Florida Withdrawn
South Miami Hospital Miami Florida Recruiting
South Miami Hospital Miami Florida Recruiting
Mercy Hospital Miami Florida Recruiting
Miami Cancer Institute at Baptist Health, Inc. Miami Florida Recruiting
Miami Cancer Institute at Baptist Health, Inc. Miami Florida Recruiting
Orlando Health Cancer Center Orlando Florida Withdrawn
Orlando Health Winnie Palmer Hospital for Woman and Babies Orlando Florida Withdrawn
Tampa General Hospital Tampa Florida Withdrawn
Georgian Cancer Center at Augusta University Augusta Georgia Recruiting
Southeastern Regional Medical Center LLC Newnan Georgia Withdrawn
St. Vincent Hospital and Health Care Center Inc Indianapolis Indiana Withdrawn
St. Vincent Hospital and Health Care Center, Inc Indianapolis Indiana Withdrawn
St. Elizabeth Healthcare Edgewood Kentucky Active Not Recruiting
Baptist Health Lexington Lexington Kentucky Recruiting
Baptist Health Lexington Kentucky Recruiting
LSU Health New Orleans New Orleans Louisiana Recruiting
Willis-Knighton Physician Network Gynecologic Oncology Associates Shreveport Louisiana Recruiting
Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology Scarborough Maine Recruiting

+ 116 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04831580 on ClinicalTrials.gov ↗ ← All trials in Brazil