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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
ROCC Trial 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.Check my eligibility
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.See study design
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.
ROCC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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).
ROCC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival
ROCC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Robotic radical hysterectomyExperimental Treatment1 Intervention
Group II: Open radical hysterectomyActive Control1 Intervention
Find a Location
Who is running the clinical trial?
GOG FoundationLead Sponsor
42 Previous Clinical Trials
15,901 Total Patients Enrolled
Intuitive FoundationUNKNOWN
1 Previous Clinical Trials
27 Total Patients Enrolled
Kristin Bixel, MDStudy ChairThe Ohio State Unversity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I am fit for surgery as per my recent lab tests and EKG.My cancer has spread to other parts of my body or lymph nodes.I am 18 years old or older.My cancer is between stage 1A1 and stage IV according to FIGO 2018.My cervical cancer is in an early stage without spread to other areas.My CD4 count is below 500, indicating poorly controlled HIV.My tumor is at least 4cm or has spread to the vaginal/parametrial area.I am pre-menopausal and have a negative pregnancy test within 30 days of surgery.I cannot stay in positions where my legs are raised high or I'm tilted backward for long.My cancer is not neuroendocrine or certain types of adenocarcinoma.I have had radiotherapy in my pelvis or abdomen before.My cancer is confirmed to be a specific type (like adenocarcinoma or squamous cell).I haven't had cancer, except for non-melanoma skin cancer, in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Robotic radical hysterectomy
- Group 2: Open radical hysterectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the geographic scope of this trial's implementation?
"This medical trial is being held at St. Vincent Hospital and Health Care Center Inc in Indianapolis, Indiana, Chattanooga's Program in Women's Oncology in Chattanooga, Tennessee, Kettering Health Cancer Center in Kettering Ohio as well as 7 other sites."
Answered by AI
Is there an enrollment period for participants currently open?
"According to clinicaltrials.gov, this experiment is actively enrolling participants. The trial was first publicized on March 22nd 2022 and the most recent amendment made to it occurred April 13th of that year."
Answered by AI
How many participants are engaged in this experiment?
"Affirmative. Details on clinicaltrials.gov demonstrate that, as of April 13th 2022, this research is still recruiting volunteers. Initially posted on March 22nd 2022, the trial seeks 840 participants from 7 distinct medical facilities."
Answered by AI
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