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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Minimally invasive pelvic exenteration
Procedure/SurgeryIf 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.
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: Recruited patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disease free survival (DFS)
The primary aim is to assess the 3-year disease free survival
Time frame
From the enrollment for the following three years.Secondary outcomes
1
Overall survival (OS)
One of the secondary aim is to assess the overall survival.
Time frame
Survival time is calculated from the date of surgery until the date of death from any cause, or for patients still alive to the date of last clinical follow-up or contact, assessed up to 100 months.2
Intraoperative complication rate
Intraoperative complications will be assessed with CTCAE 5.0 classification (Common Terminology Criteria for Adverse Events).
Time frame
During the procedure3
Post-operative complication rate
Post-operative complications: will be assessed with Clavien-Dindo classification
Time frame
One month and six months after surgery4
Health Related Quality of Life (HRQoL) n.1
Quality of life will be assessed by questionnaires completed by study participants preferably as electronical patient reported outcome measures or during the clinic visit. Questionnaire n. 1 comprises the EORTC QLQ-30 (version 3.0, EORTC: European Organization for Research and Treatment of Cancer; QLQ: Quality-of-Life questionnaire).
Time frame
At baseline and one month, six months, one years and two years after surgery.Sponsors and contacts
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Source ClinicalTrials.gov