Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a type of surgery called minimally invasive pelvic exenteration for women who have had a recurrence or ongoing issues with cervical or vaginal cancer. The main goal of the study is to see how effective this surgery is in helping patients remain free from cancer for at least three years. Researchers will also look at overall survival rates, any complications that may occur during or after surgery, and how the surgery affects the patients' quality of life.

To participate in the trial, women must be over 18 years old and have a confirmed diagnosis of recurrent or persistent vaginal or cervical cancer, specifically certain types like squamous carcinoma or adenocarcinoma. They should have a single area of cancer in the pelvic region, and the tumor must be smaller than 50 mm. Participants will be carefully monitored throughout the trial, and they will need to sign an informed consent form to take part. It's important to note that some women may not be eligible if they have certain medical conditions or if their cancer has spread beyond the pelvic area.

Gender

FEMALE

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