Cervical Carcinoma, Endometrial Carcinoma, Gynecologic Tumor, Ovarian Carcinoma, Uterine Sarcoma, Vulvar Carcinoma
Conditions
Keywords
Advanced or recurrent gynecologic tumor, Vascular infiltration
Brief summary
Multicenter ambispective observational study (prospective/retrospective)
Detailed description
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).
Interventions
None listed
Sponsors
National Cancer Institute, Naples
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Retrospective Arm: 1. Diagnosis of advanced or recurrent gynecologic cancer with vascular involvement requiring resection and/or reconstruction of major blood vessels, including: * Ovarian carcinoma * Cervical carcinoma * Endometrial carcinoma * Vulvar carcinoma * Uterine or other types of sarcomas with vascular involvement 2. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description. 3. Patients who underwent onco-vascular surgery for advanced or recurrent gynecologic cancers between January 1, 2017, and August 31, 2025. 4. Data Protection Impact Assessment (DPIA) approved for the management of retrospective data. (Deceased or untraceable patients will also be included to avoid selection bias, in accordance with Article 110 bis, paragraph 4 of the Italian Privacy Code. A DPIA will be produced and published on the Sponsor's website before study initiation, and patients who explicitly objected before death will not be included.) Prospective Arm: 1. Age ≥18 years 2. Patients eligible for onco-vascular surgery for advanced or recurrent gynecologic cancers with vascular involvement, including: * Ovarian carcinoma * Cervical carcinoma * Endometrial carcinoma * Vulvar carcinoma * Uterine or other types of sarcomas 3. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description. 4. Signed informed consent.
Exclusion criteria
1. Patients younger than 18 years of age 2. Patients with early-stage gynecologic cancers not eligible for onco-vascular surgery 3. Patients undergoing vascular resection due to accidental injury of blood vessels not directly related to tumor infiltration. 4. Patients who have previously undergone vascular surgery for reasons unrelated to the study, to avoid data overlap.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 5 years from the date of surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days of postoperative hospital stay | From the date of surgery until post-operative hospital discharge(assessed up to 30 days after surgery) | — |
| Progression-Free Survival (PFS) | 5 years from the date of surgery | 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 |
| Frequency of early postoperative complications | 30 days post-surgery | Complications will be classified according to the Clavien-Dindo system |
| Frequency of late postoperative complications | 180 days post-surgery | Complications will be classified according to the Clavien-Dindo system. |
| Quality of Life assessment using the EORTC QLQ-C30 questionnaire | Baseline (30 days pre-surgery) and 1 month, 3 months, 6 months ans 12 months post-surgery | Questionnaire administration |
Countries
Italy
Contacts
Primary ContactGiuseppe Cucinella, MD
Outcome results
None listed