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Robotic Surgery

Robotic vs Open Hysterectomy for Cervical Cancer (ROCC Trial)

N/A
Recruiting
Research Sponsored by GOG Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have ECOG performance status 0-1
Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging
Must not have
Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes)
Patients with FIGO stage 1A1, IB3, II-IV (2018 staging)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two methods of treatment for cervical cancer to see which one is more effective.

Who is the study for?
This trial is for adults over 18 with early-stage cervical cancer (specific types like adenocarcinoma, squamous cell carcinoma) who are fit for surgery and have no evidence of widespread cancer. They must be able to consent, have a uterus size suitable for vaginal delivery of the specimen, and an ECOG performance status of 0-1.
What is being tested?
The study compares robotic-assisted laparoscopy using da Vinci technology versus traditional open radical hysterectomy in treating early-stage cervical cancer. It aims to see which method offers better survival rates.
What are the potential side effects?
Potential side effects may include pain at the surgical site, infection risk, bleeding complications, possible damage to nearby organs or tissues during surgery, and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cervical cancer is in an early stage without spread to other areas.
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I am 18 years old or older.
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My cancer is confirmed to be a specific type (like adenocarcinoma or squamous cell).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to other parts of my body or lymph nodes.
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My cancer is between stage 1A1 and stage IV according to FIGO 2018.
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My CD4 count is below 500, indicating poorly controlled HIV.
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My tumor is at least 4cm or has spread to the vaginal/parametrial area.
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I cannot stay in positions where my legs are raised high or I'm tilted backward for long.
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My cancer is not neuroendocrine or certain types of adenocarcinoma.
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I have had radiotherapy in my pelvis or abdomen before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Robotic radical or simple hysterectomyExperimental Treatment1 Intervention
Group II: Open radical or simple hysterectomyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

GOG FoundationLead Sponsor
46 Previous Clinical Trials
16,810 Total Patients Enrolled
Intuitive FoundationUNKNOWN
1 Previous Clinical Trials
27 Total Patients Enrolled
Kristin Bixel, MDStudy ChairStandford University

Media Library

da Vinci (Robotic Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT04831580 — N/A
Cervical Cancer Research Study Groups: Robotic radical or simple hysterectomy, Open radical or simple hysterectomy
Cervical Cancer Clinical Trial 2023: da Vinci Highlights & Side Effects. Trial Name: NCT04831580 — N/A
da Vinci (Robotic Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04831580 — N/A
~475 spots leftby Aug 2028
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