Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence

NCT ID: NCT06867445

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2031-03-01

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.

Conditions

Cervical Cancers; Vaginal Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Recruited patients

Cervical cancer or vaginal cancer patients with recurrent/persistent disease assessed for elegibility

Group Type: EXPERIMENTAL

Minimally invasive pelvic exenteration

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Bizzarri Nicolò

Medical Doctor in the Gynecologic Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Scambia, MD, PhD

Role: STUDY_DIRECTOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Policlinico Agostino Gemelli IRCCS

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Nicolò Bizzarri

Role: CONTACT

nicolo.bizzarri@policlinicogemelli.it

0630156249

Facility Contacts

Nicolò Bizzarri

Role: primary

nicolo.bizzarri@policlinicogemelli.it

0630156249

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Other Identifiers

ID 7338

Identifier Type: -

Identifier Source: org_study_id