An observational study in Ovarian Carcinoma, Cervical Carcinoma and Endometrial Carcinoma, sponsored by National Cancer Institute, Naples. Not yet recruiting at 2 sites in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by National Cancer Institute, Naples · Observational
Multicenter ambispective observational study (prospective/retrospective)
This multicenter ambispective observational study, including both a retrospective phase (patients treated surgically between January 1, 2017, and August 31, 2025) and a prospective phase, aims to evaluate the role of onco-vascular surgery in the treatment of advanced and recurrent gynecologic cancers. Onco-vascular surgery involves the simultaneous resection and reconstruction of major blood vessels when the tumor infiltrates or adheres firmly to them, and its benefits have been demonstrated in other malignancies such as hepatobiliary-pancreatic cancers and retroperitoneal soft tissue sarcomas. In the context of gynecologic oncology, this surgical approach is an emerging field with the potential to increase the rate of complete (R0) resection without increasing morbidity or mortality. However, data on the frequency, safety, and oncologic outcomes of vascular surgery in gynecologic oncology remain limited.
The study collects data on patient demographics, tumor characteristics, surgical details, postoperative complications, adjuvant therapies, oncologic outcomes, and quality of life (EORTC QLQ-C30).
Primary Objective: To describe overall survival in patients with advanced or recurrent gynecologic cancers undergoing onco-vascular surgery. Additionally, survival outcomes-including overall survival and 5-year progression-free survival-will be assessed for each patient subgroup, stratified by gynecologic cancer type and disease status (initial diagnosis vs. recurrence).
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 130 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The target population of the study consists of patients with advanced or recurrent gynecologic cancers involving major blood vessels by continuity or contiguity, who undergo en bloc tumor resection with simultaneous vascular resection and reconstruction during surgery for disease management.
- Retrospective Arm:
Diagnosis of advanced or recurrent gynecologic cancer with vascular involvement requiring resection and/or reconstruction of major blood vessels, including:
Prospective Arm:
Patients eligible for onco-vascular surgery for advanced or recurrent gynecologic cancers with vascular involvement, including:
Exclusion Criteria:
Includes patients who underwent surgical treatment in the 8 years prior to the prospective study (January 1, 2017 - August 31, 2025).
Overall Survival (OS)
Overall Survival (OS) at 5 years post-surgery, defined as the time from the surgical intervention to death from any cause. For patients who are still alive, OS will be censored at the date of the last follow-up.
Time frame: 5 years from the date of surgery
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) at 5 years post-surgery Defined as the time from surgery to the first detection of recurrence or death, whichever occurs first. For patients without events, PFS will be censored at the date of the last follow-u
Time frame: 5 years from the date of surgery
Frequency of early postoperative complications
Complications will be classified according to the Clavien-Dindo system
Time frame: 30 days post-surgery
Frequency of late postoperative complications
Complications will be classified according to the Clavien-Dindo system.
Time frame: 180 days post-surgery
Quality of Life assessment using the EORTC QLQ-C30 questionnaire
Questionnaire administration
Time frame: Baseline (30 days pre-surgery) and 1 month, 3 months, 6 months ans 12 months post-surgery
Number of days of postoperative hospital stay
Time frame: From the date of surgery until post-operative hospital discharge(assessed up to 30 days after surgery)
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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National Cancer Institute, Naples