Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
NCT03372720
Adnexal Diseases, Cervical Carcinoma
Baltimore, Maryland, United States
View Trial DetailsNCT Number: NCT07267780
Multicenter ambispective observational study (prospective/retrospective)
Trial opening soon.
Get Notified18 year and older
Female
Observational
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Campania, Italy
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Prospective Arm:
Exclusion criteria
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.
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
Time frame: 30 days post-surgery
Complications will be classified according to the Clavien-Dindo system
Time frame: 180 days post-surgery
Complications will be classified according to the Clavien-Dindo system.
Time frame: Baseline (30 days pre-surgery) and 1 month, 3 months, 6 months ans 12 months post-surgery
Questionnaire administration
Time frame: From the date of surgery until post-operative hospital discharge(assessed up to 30 days after surgery)
Contact information is provided by the study sponsor or research team.
National Cancer Institute, Naples
Other
The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study
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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