Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ovarian Carcinoma, Cervical Carcinoma, Endometrial Carcinoma, Vulvar Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study
Overview
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).
Primary outcome measures
- Overall Survival (OS) [Time frame: 5 years from the date of surgery]
Secondary outcome measures (5)
- Progression-Free Survival (PFS) [Time frame: 5 years from the date of surgery]
- Frequency of early postoperative complications [Time frame: 30 days post-surgery]
- Frequency of late postoperative complications [Time frame: 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]
- 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)]
Eligibility criteria
Inclusion criteria
\- Retrospective Arm:
- 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
- Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.
- Patients who underwent onco-vascular surgery for advanced or recurrent gynecologic cancers between January 1, 2017, and August 31, 2025.
- 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:
- Age ≥18 years
- 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
- Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.
- Signed informed consent.
Exclusion criteria
- Patients younger than 18 years of age
- Patients with early-stage gynecologic cancers not eligible for onco-vascular surgery
- Patients undergoing vascular resection due to accidental injury of blood vessels not directly related to tumor infiltration.
- Patients who have previously undergone vascular surgery for reasons unrelated to the study, to avoid data overlap.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale — Naples
- A.R.N.A.S. Ospedali Civico Di Cristina Benfratell — Palermo
Identifiers
NCT: NCT07267780 · ONCOVASCULAR SURGERY