Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence (MIPEX)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Vaginal Cancers

Cervical Cancers

Treatments

Procedure: Minimally invasive pelvic exenteration

Study type

Interventional

Funder types

Other

Identifiers

NCT06867445

ID 7338

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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