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

November 25, 2025 updated by: National Cancer Institute, Naples

The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study

Multicenter ambispective observational study (prospective/retrospective)

Study Overview

Status

Not yet recruiting

Conditions

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).

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
        • Principal Investigator:
          • Giuseppe Cucinella, MD
    • Italy
      • Palermo, Italy, Italy
        • A.R.N.A.S. Ospedali Civico Di Cristina Benfratell
        • Principal Investigator:
          • Antonino Abbate, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Retrospective Arm (30 patients)
Includes patients who underwent surgical treatment in the 8 years prior to the prospective study (January 1, 2017 - August 31, 2025).
Prospective Arm (100 patients)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 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.
5 years from the date of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 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
5 years from the date of surgery
Frequency of early postoperative complications
Time Frame: 30 days post-surgery
Complications will be classified according to the Clavien-Dindo system
30 days post-surgery
Frequency of late postoperative complications
Time Frame: 180 days post-surgery
Complications will be classified according to the Clavien-Dindo system.
180 days post-surgery
Quality of Life assessment using the EORTC QLQ-C30 questionnaire
Time Frame: Baseline (30 days pre-surgery) and 1 month, 3 months, 6 months ans 12 months post-surgery
Questionnaire administration
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)
From the date of surgery until post-operative hospital discharge(assessed up to 30 days after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCOVASCULAR SURGERY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Sarcoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe