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Application of da Vinci SP for Endometrial Cancer Surgical Staging

ConditionEndometrial Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNational Cancer Institute, Naples

About this trial

Prospective Multicenter Observational Study The study involves the consecutive inclusion of every patient with endometrial cancer undergoing staging surgical treatment using a robotic approach with the da Vinci SP platform.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Histologically confirmed endometrial carcinoma (including uterine carcinosarcoma)

Performance status (ECOG) 0 - 1

Patients undergoing staging surgery for endometrial cancer, including but not limited to robotic hysterectomy with bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion) and possible sentinel lymph node biopsy/pelvic ± para-aortic lymphadenectomy

Disqualifiers

Patients scheduled for an additional extra-genital surgical procedure during the staging surgery for endometrial carcinoma

Patients with anesthesiological contraindications to a minimally invasive approach

Synchronous tumor

Recurrence of endometrial carcinoma

Trial population

Women with histologically confirmed endometrial carcinoma at first diagnosis who have planned staging surgery for endometrial cancer to be performed using the robotic approach with the da Vinci SP platform

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Robotic surgical staging

    Procedure/Surgery

    The intervention includes hysterectomy, bilateral salpingo-oophorectomy, and sentinel lymph node mapping, with possible lymphadenectomy or omentectomy, depending on histology.

Treatment groups

564 Participants
are divided into 1 treatment group
Group A: Da Vinci SP Surgical Staging Group1 intervention

Trial outcomes

Primary outcomes

1

Rate of satisfactory completion of staging surgery according to the criteria of national and international guidelines for the treatment of endometrial carcinoma.

Time frame
12 months
2

Rate of intraoperative complications, after categorization based on the type of complication and the timing of its occurrence.

Time frame
12 months
3

Rate of postoperative complications, after categorization based on the type of complication (within 30 days after surgery, after 30 days post-surgery) and according to the Clavien-Dindo classification.

Time frame
48 months

Secondary outcomes

1

Disease-Free Survival (DFS) calculated from the date of randomization to the date of death from any cause or censored at the date of the last follow-up, after categorization based on molecular class and tumor prognostic factors.

Time frame
up to 48 months (4 years)
2

Overall Survival (OS) calculated from the date of randomization to the date of death from any cause or censored at the date of the last follow-up, after categorization based on molecular class and tumor prognostic factors.

Time frame
up to 48 months (4 years)
3

Quality of Life (QoL) assessed using the questionnaires from the EORTC QLQ-C30 (Version 3).

Time frame
From baseline (pre-treatment) up to 48 months (4 years) post-randomization, with assessments every 6 months
4

Quality of Life (QoL) assessed using the questionnaires from EORTC QLQ-OV28.

Time frame
From baseline (pre-treatment) up to 48 months (4 years) post-randomization, with assessments every 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute, Naples

Lead sponsor

Source ClinicalTrials.gov
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