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New treatment option for Cervical Cancers
Official title Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
ClinicalTrials.gov ID: NCT06867445
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.