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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNational Cancer Institute, Naples

About this trial

Multicenter ambispective observational study (prospective/retrospective)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ovarian carcinoma

Cervical carcinoma

Endometrial carcinoma

Vulvar carcinoma

Disqualifiers

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.

Trial population

The target population of the study consists of patients with advanced or recurrent gynecologic cancers involving major blood vessels by continuity or contiguity, who undergo en bloc tumor resection with simultaneous vascular resection and reconstruction during surgery for disease management.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

130 Participants
are grouped into 2 trial groups
Group A: Retrospective Arm (30 patients)
Group B: Prospective Arm (100 patients)

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

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

Secondary outcomes

1

Progression-Free Survival (PFS)

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
5 years from the date of surgery
2

Frequency of early postoperative complications

Complications will be classified according to the Clavien-Dindo system

Time frame
30 days post-surgery
3

Frequency of late postoperative complications

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

Time frame
180 days post-surgery
4

Quality of Life assessment using the EORTC QLQ-C30 questionnaire

Questionnaire administration

Time frame
Baseline (30 days pre-surgery) and 1 month, 3 months, 6 months ans 12 months post-surgery

Other outcomes

Sponsors and contacts

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