NCT06867445Recruiting
Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 11 Feb 2025
- Start date
- Jul 2025
- Primary completion date
- Mar 2028
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Cervical cancer
- NCT number
- NCT06867445
What you commit to
- Study type: Interventional
- Planned participants: 64
- From Jul 2025 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to surgery
- Serious concomitant systemic disorders incompatible with surgery or minimally invasive surgery (at the discretion of the investigator)
Other
- 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
- Women unable to tolerate prolonged lithotomy and steep Trendelenburg positions
- Women with secondary invasive neoplasm in the last 5 years
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.