NCT06867445 Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
| NCT ID | NCT06867445 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Cervical Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2025-07-07 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Giovanni Scambia, MD, PhD
STUDY DIRECTOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06867445 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06867445 currently recruiting?
Yes, NCT06867445 is actively recruiting participants. Contact the research team at nicolo.bizzarri@policlinicogemelli.it for enrollment information.
Where is the NCT06867445 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06867445 clinical trial?
NCT06867445 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Giovanni Scambia, MD, PhD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 64 participants.
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