Minimally invasive surgery for recurrent cervical or vaginal cancer
Official title: Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06867445 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 64 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | July 7, 2025 |
| Main results expected | March 1, 2028 |
| Study ends | March 1, 2031 |
| Registry record updated | July 17, 2025 |
| Trial ID | NCT06867445 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with distant metastasis, significant lymph node involvement, or contraindications to surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Policlinico Agostino Gemelli IRCCS
Rome, Italy Recruiting
Study contacts
- Study coordinator: Nicolò Bizzarri
- Email: nicolo.bizzarri@policlinicogemelli.it
- Phone: 0630156249
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.