Trials / Not Yet Recruiting
Not Yet RecruitingNCT07267780
Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.
The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 130 (estimated)
- Sponsor
- National Cancer Institute, Naples · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2030-12-01
- Completion
- 2035-12-01
- First posted
- 2025-12-05
- Last updated
- 2025-12-05
Locations
2 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT07267780. Inclusion in this directory is not an endorsement.