Application of da Vinci SP for Endometrial Cancer Surgical Staging

NCT07027046 | Recruiting

• 1 other identifier: SP endometrial cancer
• Study Type: observational
• Target: 564
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (3)

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

  12 months

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

  12 months

• 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.

  48 months

Secondary Outcomes (5)

• 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.

  up to 48 months (4 years)

• 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.

  up to 48 months (4 years)

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

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

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

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

• Quality of Life (QoL) assessed using the questionnaires from the EQ-5D-3L.

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

Study Arms (1)

Da Vinci SP Surgical Staging Group

Patients with early-stage endometrial cancer undergoing robotic surgical staging using the Da Vinci SP system.

Procedure: Robotic surgical staging

Interventions

Robotic surgical staging PROCEDURE

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

Da Vinci SP Surgical Staging Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Age ≥ 18 years
• Histologically confirmed endometrial carcinoma (including uterine carcinosarcoma)
• Performance status (ECOG) 0 - 1
• Signed informed consent to participate in the study

You may not qualify if:

• 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
• Dementia or significantly altered mental status that may impair understanding and the ability to provide informed consent
• Any reason that may interfere with regular follow-up, even if limited to the first 30 days post-surgery

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (3)

Istituto Nazionale Tumori | "Fondazione Pascale"

Napoli, Napoli, 80131, Italy

RECRUITING

IEO - Istituto Europeo di Oncologia

Milan, Italy

RECRUITING

Istituti Fisioterapici Ospitalieri - IFO

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Vito Chiantera, MD

  IRCCS I.N.T. "G. Pascale"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Cucinella, MD

CONTACT

00000000000; giuseppe.cucinella@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 18, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

IT (3)