Comparing open surgery with da Vinci for cervical cancer
Official title: A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer (ROCC)
- 2 groups
- Sites in Montreal and Toronto
- Recruiting
Interventions
- Medical device
da Vinci
Minimally invasive robotic-assisted radical or simple hysterectomy
- Other intervention
open surgery
open radical or simple hysterectomy
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
Centre Hospitalier De L'Universite De Montreal
Montreal
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario
- Recruiting
McGill University Health Centre-Glen Site
Montreal, Quebec
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Submission of source documents in the GOG Partners Source Document Portal will be required prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → for review and confirmation of simple hysterectomy being met (see Section 6.0 for instructions).
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- +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.
- +Patient must be age 18 years or older.
- +Patient must have signed an approved informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and authorization permitting the release of personal health information.
- +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.
Exclusion
- −Patients with poorly controlled HIV with CD4 counts \<500.
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives open surgery.
Registry label: A: Open radical or simple hysterectomy
Group B receives da Vinci.
Registry label: B: Robotic radical or simple hysterectomy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 840 people.
The study is currently expected to finish around March 2030.
The main measurement is taken over: 36 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Survival — measured over 36 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04831580 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About da VinciDevice
Minimally invasive robotic-assisted radical or simple hysterectomy
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About open surgeryOther
open radical or simple hysterectomy
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 36 months.
The study as a whole is currently expected to finish around 2030-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 840 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 15 locations, including: Montreal, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Minneapolis, Minnesota, United States; Bay Shore, New York, United States; Brightwaters, New York, United States, and 9 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (22)
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota, United States
Northwell Health/South Shore University Hospital
Bay Shore, New York, United States
Northwell Health Physician Partners/Gynecological Oncology at Brightwaters
Brightwaters, New York, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
Brooklyn, New York, United States
NYU Langone Ambulatory Care Bay Ridge
Brooklyn, New York, United States
NYU Langone Hospital-Brooklym
Brooklyn, New York, United States
Memorial Sloan Kettering (Commack)
Commack, New York, United States
Memorial Sloan Kettering (Westchester)
Harrison, New York, United States
Northwell Health/Huntington Hospital
Huntington, New York, United States
Memorial Sloan Kettering (Monmouth)
Middletown, New York, United States
Northwell Health/Long Island Jewish Medical Center
New Hyde Park, New York, United States
NHPP/Gynecologic Oncology at New Hyde Park
New Hyde Park, New York, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street
New York, New York, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York, United States
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York, United States
Josie Robertson Surgery Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center (Main Campus)
New York, New York, United States
And 2 more sites worldwide.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.