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

NCT ID: NCT07267780

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2035-12-31

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).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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).

No interventions assigned to this group

Prospective Arm (100 patients)

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, Campania, Italy

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

Palermo, Italy, Italy

Countries

Italy

Central Contacts

Giuseppe Cucinella, MD

Role: CONTACT

giuseppe.cucinella@istitutotumori.na.it

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Other Identifiers

ONCOVASCULAR SURGERY

Identifier Type: -

Identifier Source: org_study_id