RecruitingNot ApplicableNCT06867445

Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

64 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a minimally invasive surgical approach (laparoscopic or robotic) for pelvic exenteration — a major surgery to remove cancer that has returned in the pelvis — in women with recurrent vaginal or cervical cancer. **You may be eligible if...** - You have been diagnosed with recurrent or persistent vaginal or cervical cancer - The cancer is confirmed as squamous cell, adenocarcinoma, or adenosquamous type - The cancer is limited to the central pelvis (has not spread outside) - The tumor measures no more than 50mm on MRI - You are over 18 and in adequate health for surgery **You may NOT be eligible if...** - Your cancer has spread beyond the central pelvis (to lymph nodes or other organs) - You have previously had pelvic exenteration surgery - You are pregnant - You have serious medical conditions that make major surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMinimally 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.


Locations(1)

Policlinico Agostino Gemelli IRCCS

Rome, Italy

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NCT06867445


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