Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence (NCT06867445) | Clinical Trial Compass
RecruitingNot Applicable
Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Italy64 participantsStarted 2025-07-07
Plain-language summary
The aim of this clinical trial is to assess the oncologic safety of minimally invasive pelvic exenteration in patients with recurrence or persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). The primary aim is to assess the 3-year disease-free survival (DFS). The secondary aim is to assess the 3-year overall survival (OS), the intraoperative and post-operative complication rate, and the patient's quality of life.
Who can participate
Age range
18 Years
Sex
FEMALE
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:
* Diagnosis of recurrent or persistent vaginal or cervical cancer
* Proven histological diagnosis of squamous carcinoma, adenocarcinoma or adenosquamous carcinoma
* Isolated central pelvic recurrence
* MRI-measured maximum tumor diameter ≤ 50 mm
* Age \> 18 years
* Patients who have signed an approved informed consent form
* Patients must be suitable for surgery
* ECOG Performance Status of 0, 1 or 2 (Eastern Cooperative Oncology Group)
Exclusion Criteria:
* Para-aortic lymph nodes with a short-axis diameter ≥ 15 mm on MRI scan and/or SUV max ≥ 2.5 on PET/CT scan
* Involvement of lateral pelvic structures (on preoperative imaging or during examination under anaesthesia)
* Sciatic nerve involvement (at pre-operative imaging or during examination under anaesthesia)
* Distant metastasis at PET/CT scan
* Any histological type other than squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma
* Contraindications to surgery
* Serious concomitant systemic disorders incompatible with surgery or minimally invasive surgery (at the discretion of the investigator)
* Women unable to tolerate prolonged lithotomy and steep Trendelenburg positions
* Women with secondary invasive neoplasm in the last 5 years
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.
What they're measuring
1
Disease free survival (DFS)
Timeframe: From the enrollment for the following three years.