Minimally invasive surgery for recurrent cervical or vaginal cancer

Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence

This study is testing a less invasive surgery for patients with recurring cervical or vaginal cancer to see if it can safely remove the cancer and improve their chances of staying cancer-free for three years.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Rome)
• Trial ID: NCT06867445 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the oncologic safety of minimally invasive pelvic exenteration in patients with recurrent or persistent cervical or vaginal cancer located in the pelvis. Eligible patients will undergo pre-operative assessments including MRI and PET/CT scans, followed by the surgical procedure aimed at removing the cancerous tissue while ensuring negative surgical margins. The study primarily focuses on the 3-year disease-free survival rate, while also assessing overall survival, complication rates, and quality of life post-surgery.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a histological diagnosis of recurrent or persistent cervical or vaginal cancer and isolated central pelvic recurrence.

Not a fit: Patients with distant metastasis, significant lymph node involvement, or contraindications to surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer surgical option with improved recovery outcomes for patients with recurrent cervical or vaginal cancer.

How similar studies have performed: While minimally invasive techniques in oncology are gaining traction, this specific approach to pelvic exenteration for these cancers is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Rome

• Policlinico Agostino Gemelli IRCCS — Rome, Italy (RECRUITING)

Study contacts

• Study coordinator: Nicolò Bizzarri

Conditions: Cervical Cancers, Vaginal Cancers, cervical cancer, vaginal cancer, minimally invasive surgery, pelvic exenteration, gynecologic oncology