Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Minimally invasive pelvic exenteration
Treatment groups
64 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov