Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.

N/ANot Yet RecruitingNCT07267780

National Cancer Institute, Naples130 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Ovarian Carcinoma Cervical Carcinoma Endometrial Carcinoma Vulvar Carcinoma Uterine Sarcoma Gynecologic Tumor

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, Campania, Italy

A.R.N.A.S. Ospedali Civico Di Cristina Benfratell

Palermo, Italy, Italy

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Central Contacts

Giuseppe Cucinella, MD

CONTACT

0000000000 giuseppe.cucinella@istitutotumori.na.it

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.