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A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

ConditionCervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGOG Foundation

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • da Vinci

    Device

    Minimally invasive robotic-assisted radical or simple hysterectomy

  • open surgery

    Other intervention

    open radical or simple hysterectomy

Treatment groups

840 Participants
are divided into 2 treatment groups
Group A: Open radical or simple hysterectomyActive comparator 1 intervention
Group B: Robotic radical or simple hysterectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival

3 year disease-free survival

Time frame
36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GOG Foundation

Lead sponsor

Intuitive Foundation

Collaborator

Source ClinicalTrials.gov
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