Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers (NCT05186493) | Clinical Trial Compass
RecruitingNot Applicable
Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers
Norway40 participantsStarted 2021-11-01
Plain-language summary
The Radium Hospital Oslo University Hospital Estimated date of first patient enrolled: 3rd quarter 2021 Anticipated recruitment period: 4 years Estimated date of last patient completed: 4th quarter 2025
Locally advanced pelvic cancer that requires total pelvic exenteration
Expected study-specific follow-up period per patient: 5 years according to standard follow-up for this patient group
Primary endpoint:
R0 resection rate (circumferential resection margin \>1mm)
Secondary endpoints:
Rate of conversion to open surgery, peri- and postoperative complications, hospital length of stay, wound healing at 3 months follow-up, Quality of Life measured by EORTC Quality of Life Questionnaire C-30 preoperatively, at 3 months and 3 year follow-ups, disease-free survival, overall survival.
Diagnosis specific endpoints.
Open label observational study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (\>18 years)
* locally advanced pelvic cancer that require pelvic exenteration
* eligible for robot- assisted minimally invasive surgery by the respective multidisciplinary teams, may be included in the study.
Exclusion Criteria:
* Any reason why the patient in the investigator's opinion is not suited for inclusion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.