Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
Policlinico Agostino Gemelli IRCCS
RECRUITING
Rome
Contact Information
Primary
Nicolò Bizzarri
nicolo.bizzarri@policlinicogemelli.it
0630156249
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2031-03-01
Participants
Target number of participants: 64
Treatments
Experimental: Recruited patients
Cervical cancer or vaginal cancer patients with recurrent/persistent disease assessed for elegibility
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov

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