Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence

Condition(s) studied

Investigational drug(s) / intervention(s)

Minimally invasive pelvic exenteration: If all criteria are met, patients are registered. The patient is enrolled before the surgery, at the time of pelvic evaluation under anaesthesia. A diagnostic laparoscopic assessment can be performed before the operation to exclude peritoneal metastasis. The experimental procedure in this protocol involves the use of a minimally invasive approach (robot-assisted or laparoscopic) for performing pelvic exenteration.

Study 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.

Eligibility

Primary outcome measure(s)

• Disease free survival (DFS) — From the enrollment for the following three years.
  The primary aim is to assess the 3-year disease free survival

Trial sites (1)

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