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

July 11, 2025 updated by: Bizzarri Nicolò, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recruited patients
Cervical cancer or vaginal cancer patients with recurrent/persistent disease assessed for elegibility
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: From the enrollment for the following three years.
The primary aim is to assess the 3-year disease free survival
From the enrollment for the following three years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
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.
One of the secondary aim is to assess the overall survival.
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.
Intraoperative complication rate
Time Frame: During the procedure
Intraoperative complications will be assessed with CTCAE 5.0 classification (Common Terminology Criteria for Adverse Events).
During the procedure
Post-operative complication rate
Time Frame: One month and six months after surgery
Post-operative complications: will be assessed with Clavien-Dindo classification
One month and six months after surgery
Health Related Quality of Life (HRQoL) n.1
Time Frame: At baseline and one month, six months, one years and two years after surgery.

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).
At baseline and one month, six months, one years and two years after surgery.
Health Related Quality of Life (HRQoL) n. 2
Time Frame: At baseline and one month, six months, one years and two years after surgery.

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. 2 comprises the EORTC QLQCX24 (European Organization for Research and Treatment of Cancer; QLQ: Quality-of-Life questionnaire)
At baseline and one month, six months, one years and two years after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Study Director: Giovanni Scambia, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 7338

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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