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NCT Number: NCT07267780

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

Multicenter ambispective observational study (prospective/retrospective)

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Frequency of early postoperative complications

    Time frame: 30 days post-surgery

    Complications will be classified according to the Clavien-Dindo system

  3. Frequency of late postoperative complications

    Time frame: 180 days post-surgery

    Complications will be classified according to the Clavien-Dindo system.

  4. 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

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Cucinella, MD

CONTACT

[email protected]

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Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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