Actively Recruiting
Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-07-17
64
Participants Needed
1
Research Sites
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Policlinico Agostino Gemelli IRCCS
Rome, Italy
Actively Recruiting
Research Team
N
Nicolò Bizzarri
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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