Endometrial CancerNCT07027046
Application of da Vinci SP for Endometrial Cancer Surgical Staging
An observational study of Endometrial Cancer, run by National Cancer Institute, Naples at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Robotic surgical staging
- Type of treatment
- Surgery or procedure
- How many people
- 564 participants
- Where
- 3 sitesItaly
- Study dates
- 3 Apr 2025to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
- Signed informed consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IEO - Istituto Europeo di Oncologia
Milan
Vanna Zanagnolo, MD, vanna.zanagnolo@ieo.it
- Recruiting
Istituto Nazionale Tumori | "Fondazione Pascale"
Naples, Napoli, 80131
Giuseppe Cucinella, MD, 00000000000, giuseppe.cucinella@istitutotumori.na.it
- Recruiting
Istituti Fisioterapici Ospitalieri - IFO
Roma
Enrico Vizza, MD, enrico.vizza@ifo.it
About this study
Official title: Application of da Vinci SP for Endometrial Cancer Surgical Staging: a Prospective Multicenter Study
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.
Read the detailed description
The standard treatment for early-stage endometrial cancer is surgical staging, which includes total hysterectomy with bilateral salpingo-oophorectomy and surgical lymph node assessment.
The well-known advancements in minimally invasive surgery (MIS) have enabled laparoscopic and robotic surgical staging in gynecologic oncology. In the case of endometrial cancer, MIS is indeed the preferred surgical approach. Following the approval of the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) for gynecological procedures by the United States Food and Drug Administration in 2005, the use of robotic surgery for endometrial cancer has significantly increased, with favorable outcomes even compared to conventional laparoscopy.
The growing need for increasingly less invasive surgical options has led to the development of the possibility to perform endometrial cancer surgical staging through a single abdominal incision. Despite several attempts to apply single-incision techniques to laparoscopy in the context of endometrial cancer, the standard minimally invasive approach for hysterectomy remains the four-trocar laparoscopic technique. One of the main reasons is that introducing both the endoscope and instruments through a single incision creates internal and external conflicts between instruments and the surgeon's hands. The parallel placement of surgical instruments leads to clashes and restricts the range of motion.
To overcome these limitations, robotic technology may be applied to the single-incision technique. The recent introduction of single-port robotic surgery with the fourth-generation da Vinci® SP Surgical System represents a technological advancement. In fact, the system's flexible articulation of instruments allows for more effective manipulation while reducing instrument collisions. Moreover, the flexible camera provides a new operational angle in all directions.
The new da Vinci SP Surgical System (SP) received regulatory approval for use in gynecologic surgery in Italy in 2024. However, to date, studies in the literature on the use of the da Vinci SP robot in patients with endometrial cancer are limited due to the relatively small number of patients, single-center settings, and the retrospective nature of most studies.
Because of these limitations in the literature, definitive evidence is still lacking regarding the efficacy and safety profile of the da Vinci SP in surgical staging of early-stage endometrial cancer.
Based on these premises, the aim of this study is to clarify the outcomes associated with this minimally invasive robotic approach by reporting one of the first experiences of robotic surgical staging for endometrial cancer using the new da Vinci SP robotic platform.
The primary objective of the study is to evaluate the surgical efficacy profile of the minimally invasive robotic approach using the da Vinci SP platform for the surgical staging of endometrial cancer.
- Conditions
- Endometrial Cancer
- Being tested
- Robotic surgical staging
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgical stagingProcedure or surgery
The intervention includes hysterectomy, bilateral salpingo-oophorectomy, and sentinel lymph node mapping, with possible lymphadenectomy or omentectomy, depending on histology.
| Study group | Role | What they receive |
|---|---|---|
| Da Vinci SP Surgical Staging Group | Patients with early-stage endometrial cancer undergoing robotic surgical staging using the Da Vinci SP system. Receives: Procedure: Robotic surgical staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of satisfactory completion of staging surgery according to the criteria of national and international guidelines for the treatment of endometrial carcinoma.
Measured: 12 months
Rate of intraoperative complications, after categorization based on the type of complication and the timing of its occurrence.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 48 months (4 years)
Quality of Life (QoL) assessed using the questionnaires from the EORTC QLQ-C30 (Version 3).
Measured: 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.
Measured: 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.
Measured: From baseline (pre-treatment) up to 48 months (4 years) post-randomization, with assessments every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start3 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vito Chiantera, MD, Principal investigator, IRCCS I.N.T. "G. Pascale"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027046
- Sponsor's protocol ID
- SP endometrial cancer
- Status last verified
- Sep 2025
- First submitted
- 30 May 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of da Vinci SP for Endometrial Cancer Surgical Staging: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT07027046
- Acronym / sponsor ID
- SP endometrial cancer
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard treatment for early-stage endometrial cancer is surgical staging, which includes total hysterectomy with bilateral salpingo-oophorectomy and surgical lymph node assessment.
The well-known advancements in minimally invasive surgery (MIS) have enabled laparoscopic and robotic surgical staging in gynecologic oncology. In the case of endometrial cancer, MIS is indeed the preferred surgical approach. Following the approval of the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) for gynecological procedures by the United States Food and Drug Administration in 2005, the use of robotic surgery for endometrial cancer has significantly increased, with favorable outcomes even compared to conventional laparoscopy.
The growing need for increasingly less invasive surgical options has led to the development of the possibility to perform endometrial cancer surgical staging through a single abdominal incision. Despite several attempts to apply single-incision techniques to laparoscopy in the context of endometrial cancer, the standard minimally invasive approach for hysterectomy remains the four-trocar laparoscopic technique. One of the main reasons is that introducing both the endoscope and instruments through a single incision creates internal and external conflicts between instruments and the surgeon's hands. The parallel placement of surgical instruments leads to clashes and restricts the range of motion.
To overcome these limitations, robotic technology may be applied to the single-incision technique. The recent introduction of single-port robotic surgery with the fourth-generation da Vinci® SP Surgical System represents a technological advancement. In fact, the system's flexible articulation of instruments allows for more effective manipulation while reducing instrument collisions. Moreover, the flexible camera provides a new operational angle in all directions.
The new da Vinci SP Surgical System (SP) received regulatory approval for use in gynecologic surgery in Italy in 2024. However, to date, studies in the literature on the use of the da Vinci SP robot in patients with endometrial cancer are limited due to the relatively small number of patients, single-center settings, and the retrospective nature of most studies.
Because of these limitations in the literature, definitive evidence is still lacking regarding the efficacy and safety profile of the da Vinci SP in surgical staging of early-stage endometrial cancer.
Based on these premises, the aim of this study is to clarify the outcomes associated with this minimally invasive robotic approach by reporting one of the first experiences of robotic surgical staging for endometrial cancer using the new da Vinci SP robotic platform.
The primary objective of the study is to evaluate the surgical efficacy profile of the minimally invasive robotic approach using the da Vinci SP platform for the surgical staging of endometrial cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Da Vinci SP Surgical Staging Group | – | Procedure: Robotic surgical stagingPatients with early-stage endometrial cancer undergoing robotic surgical staging using the Da Vinci SP system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
- Signed informed consent to participate in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic surgical stagingThe intervention includes hysterectomy, bilateral salpingo-oophorectomy, and sentinel lymph node mapping, with possible lymphadenectomy or omentectomy, depending on histology. | Procedure or surgery | Da Vinci SP Surgical Staging Group |
Primary outcome
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
Rate of intraoperative complications, after categorization based on the type of complication and the timing of its occurrence.
Time frame: 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.
Time frame: 48 months
5 secondary outcomes
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)
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)
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
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
Quality of Life (QoL) assessed using the questionnaires from the EQ-5D-3L.
Time frame: From baseline (pre-treatment) up to 48 months (4 years) post-randomization, with assessments every 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vito Chiantera, MD principal investigator
IRCCS I.N.T. "G. Pascale"
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by National Cancer Institute, Naples at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Cucinella, MD (00000000000, giuseppe.cucinella@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.