Evaluation of survival data and two new rank order statistics arising in its consideration.
N Mantel
https://pubmed.ncbi.nlm.nih.gov/5910392Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID06867445
Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-07-17
64
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of minimally invasive pelvic exenteration surgery in women with recurrent or persistent cervical or vaginal cancer located in the pelvis. This study focuses on patients eligible for pelvic exenteration according to European Society of Gynecological Oncology (ESGO) guidelines. The main goal is to assess disease-free survival over three years, with additional evaluation of overall survival, complication rates, and quality of life. The study involves pelvic exenteration performed using a minimally invasive approach, either robot-assisted or laparoscopic. Before surgery, patients undergo diagnostic laparoscopic assessment to rule out metastasis and preoperative imaging including MRI and PET/CT scans. A mini-laparotomy up to 7 cm is allowed for reconstructive surgery. Data is collected electronically, and all patients receive surgery aiming for complete tumor removal with negative margins. Participants will be assessed with imaging scans before surgery and monitored for complications during and after the procedure. Quality of life is evaluated at multiple timepoints up to two years post-surgery. Overall survival is tracked for up to 100 months after surgery. The study requires informed consent and involves detailed follow-up to measure safety and effectiveness outcomes over several years.
CONDITIONS
Brief Title
Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- 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 64 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)
You will not qualify if you...
- Para-aortic lymph nodes with a short-axis diameter 65 15 mm on MRI scan and/or SUV max 65 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Surgery day plus immediate recovery period
Participants undergo minimally invasive pelvic exenteration surgery to remove cancerous tissue.
1 surgery day and several days of hospital stay
Follow-up
Duration - Up to 2 years after surgery
Participants are monitored for complications and recovery after surgery, including quality of life assessments.
Visits at 1 month, 6 months, 1 year, and 2 years after surgery
Trial Site Locations
Total: 1 location
1
Policlinico Agostino Gemelli IRCCS
Rome, Italy
Actively Recruiting
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Research Team
N
Nicolò Bizzarri
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Indications and long-term clinical outcomes in 282 patients with pelvic exenteration for advanced or recurrent cervical cancer.
A-M Schmidt, P Imesch, D Fink...
https://pubmed.ncbi.nlm.nih.gov/22406639The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module: EORTC QLQ-CX24.
Elfriede R Greimel, Karin Kuljanic Vlasic, Ann-Charlotte Waldenstrom...
https://pubmed.ncbi.nlm.nih.gov/16977652The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.
N K Aaronson, S Ahmedzai, B Bergman...
https://pubmed.ncbi.nlm.nih.gov/8433390Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.
Daniel Dindo, Nicolas Demartines, Pierre-Alain Clavien
https://pubmed.ncbi.nlm.nih.gov/15273542Minimally Invasive Pelvic Exenteration for Gynecologic Malignancies: A Multi-Institutional Case Series and Review of the Literature.
Nicolò Bizzarri, Vito Chiantera, Alfredo Ercoli...
https://pubmed.ncbi.nlm.nih.gov/30611973Curative pelvic exenteration for recurrent cervical carcinoma in the era of concurrent chemotherapy and radiation therapy. A systematic review.
H Sardain, V Lavoue, M Redpath...
https://pubmed.ncbi.nlm.nih.gov/25922209