Clinical trial NCT06867445: Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Official title: Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancers
Vaginal Cancers
Keywords: cervical cancer
vaginal cancer
minimally invasive surgery
pelvic exenteration
gynecologic oncology
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients will be considered pre-operatively eligible in case of recurrence/persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). Histological diagnosis of recurrent or persistent disease obtained with biopsy performed during examination under anesthesia or US-guided biopsy, or RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria of progressive disease are required, as by standard clinical practice. All patients will undergo MRI pelvic scan and PET/CT scan within one month before the surgery, as by standard clinical practice. After obtaining oral and written informed consent, patients will be registered. Pelvic exenteration will be performed with the aim of removing a single specimen with negative surgical margins.

A mini-laparotomy of up to 7 cm will be allowed to complete the reconstructive phase of the procedure.

Registration data has to be entered to an electronic Case Report Form (eCRF). The Principal Investigator (PI) of the study will independently take responsibility for the development of an electronic Case Report Form (CRF) for data collection.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Contraindications to surgery
* Serious concomitant systemic disorders incompatible with surgery or minimally invasive surgery (at the discretion of the investigator)
* Women unable to tolerate prolonged lithotomy and steep Trendelenburg positions
* Women with secondary invasive neoplasm in the last 5 years

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: From the enrollment for the following three years.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 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.
measure: Health Related Quality of Life (HRQoL)
timeFrame: At baseline and one month, six months, one years and two years after surgery.
measure: Intraoperative complication rate
timeFrame: During the procedure
measure: Post-operative complication rate
timeFrame: One month and six months after surgery
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giovanni Scambia, MD, PhD
role: STUDY_DIRECTOR
References:
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citation: Bizzarri N, Chiantera V, Ercoli A, Fagotti A, Tortorella L, Conte C, Cappuccio S, Di Donna MC, Gallotta V, Scambia G, Vizzielli G. Minimally Invasive Pelvic Exenteration for Gynecologic Malignancies: A Multi-Institutional Case Series and Review of the Literature. J Minim Invasive Gynecol. 2019 Nov-Dec;26(7):1316-1326. doi: 10.1016/j.jmig.2018.12.019. Epub 2019 Jan 4.
citation: Sardain H, Lavoue V, Redpath M, Bertheuil N, Foucher F, Leveque J. Curative pelvic exenteration for recurrent cervical carcinoma in the era of concurrent chemotherapy and radiation therapy. A systematic review. Eur J Surg Oncol. 2015 Aug;41(8):975-85. doi: 10.1016/j.ejso.2015.03.235. Epub 2015 Apr 14.