Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05974995
Other study ID # 5798
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date September 1, 2029

Study information

Verified date August 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Francesco Fanfani, MD
Phone 0630153421
Email francesco.fanfani@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Data across literature suggest that robotic surgery may offer benefit specifically in patient with morbid obesity with endometrial cancer, but to date no randomized trials have been conducted to confirm these observations. This randomized controlled multicentric trial aims to evaluate the most appropriate minimally invasive surgical approach in morbidly obese (BMI >= 30) patients with endometrial carcinoma.


Description:

Background: Endometrial cancer is the fourth cancer in women, the most common gynecologic cancer in high-income countries and the second most common gynecologic cancer worldwide. The high incidence of endometrial cancer is associated with several risk factors, but the growing prevalence of obesity has been identified as one of the majors. Many patients with endometrial cancer are obese and have clinically relevant coexisting conditions that negatively affects anesthesiological parameters and surgical performance when patients undergo surgery, thus potentially increasing the risk of peri-operative complications. For patients presenting at early-stage disease the standard procedure is total hysterectomy with bilateral salpingo-oophorectomy and lymph nodal staging. Prospective and retrospective studies demonstrate that compared to systemic lymphadenectomy, sentinel lymph node mapping have high accuracy in detecting nodal metastases, and together with ultrastaging may increase the detection of lymph node metastasis with low false-negative rates in patients with apparent uterine-confined disease. Also, recent evidence proved sentinel lymph node biopsy to be a feasible and safe alternative to lymphadenectomy in high-risk endometrial cancer. Many randomized prospective studies proved laparoscopic surgical staging to be feasible in terms of short-term outcomes, equivalent in disease-free survival and no different in overall survival, thus the current surgical approach is minimally invasive. Also, innovative surgical approaches such as robotic surgery have been exploited showing equivalent oncologic outcomes when compared to traditional laparoscopic surgery. In 2015, Uccella et al. proved that laparoscopy is superior to open surgery even in case of morbid obesity. Particularly, minimally invasive surgery has been shown to have faster recovery and a higher likelihood of retroperitoneal staging in morbid obese patients, even if the number of women who received lymphadenectomy was found to be stable up to class II of obesity and then dramatically decreased to 30% for BMI>40. Similarly, the number of lymph nodes removed (when lymphadenectomy was accomplished), decreased significantly in class III obesity. However, the removal of lymph nodes can be less relevant in the era of sentinel lymph node. Once, the completing of lymphadenectomy could imply the need of conversion. In fact, the Gynecologic Oncology Group LAP2 trial showed that the odds of conversion to laparotomy during laparoscopic staging increased significantly with each unit increase in BMI, but the reason for conversion was mainly when an adequate surgical staging cannot be completed. In many retrospective studies robotic surgery has been shown to have advantages when compared to laparoscopy in obese patients. Cusimano et al published a systematic review and meta-analysis aiming to evaluate rates of conversion to laparotomy with laparoscopy or robotic surgery specifically in patients with endometrial cancer and BMI >30Kg/m2: they included 51 observational studies with a total of 10,800 patients overall and found out that although the conversion rate for patients with BMI>30 Kg/m2 is comparable between laparoscopy and robotic surgery, the proportion of patients with BMI >40 kg/m2 who experienced conversion seems to be higher in laparoscopy compared with robotic. Different reasons were described for conversion: organ/vessel injury, uterine size, advanced/ metastatic disease, inadequate exposure because of adhesions or visceral adiposity, anesthesiologic indications. In conclusion, data across literature suggest that robotic surgery may offer benefit specifically in patient with morbid obesity, but to date no randomized trials have been conducted to confirm these observations. Furthermore, conclusive data are needed to evaluate length of hospitalization, intraoperative and postoperative complications, adherence to the MSKCC nodal staging algorithm, and oncological outcomes in this group of patients. Robust data in morbidly obese endometrial cancer patients to choose the most appropriate surgical technique are missing, particularly in the era of sentinel lymph node. Moreover, conversion to laparotomy in the previous study occurred to achieve a complete surgical staging with lymphadenectomy. Thus, investigators expect to have a lower conversion rate in this study. Rationale: The rationale of the study is to find the most appropriate minimally invasive surgical approach in morbidly obese patients with endometrial carcinoma Objectives: Primary objective: To evaluate conversion rate to laparotomy with robotic surgery vs laparoscopic surgery (laparoscopic surgery referent group) Secondary objectives: - To evaluate difference in overall duration of surgery - To evaluate difference in perioperative complications - To evaluate the adherence to sentinel lymph node MSKCC algorithm - To compare ergonomics of the two different surgical approach - To compare quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery, using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire - To assess adherence to ESGO surgical Quality Index (QI, rate of uterine rupture) - To evaluate difference in overall survival and disease-free survival Primary end point: the number of surgical procedures that need a conversion over the total number of surgical procedures in the two arms. Secondary end points: - Duration in minutes of surgery - Number of patients with at least one perioperative complications measured by Clavien Dindo - To evaluate the ergonomics through the Rapid Upper Limb Assessment (RULA) assessment tool - Disease-Free Survival (DFS) defined as the time between randomization and the first detection of relapse or death, whichever event occurs first; for patients without events DFS will be censored at the date of last follow-up - Overall Survival (OS) defined as the time between randomization and death for any cause; for alive patients OS will be censored at the date of last follow-up Study Design: Randomized Controlled Multicentric Superiority trial


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 566
Est. completion date September 1, 2029
Est. primary completion date September 1, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - BMI >=30 - Age > 18 - Histologically confirmed endometrioid endometrial cancer - Clinical early stage (stage I) - No contraindication for minimally invasive surgery - ASA<4 - Written informed consent. Exclusion Criteria: - High probability of laparotomy related to uterine volume (US estimated weight >250 g) - Concomitant pelvic disease, or anatomical characteristics of the patient - (Use of uterine manipulator) - Age >75 years

Study Design


Intervention

Procedure:
Robot-assisted surgery
Total hysterectomy with bilateral salpingo-oophorectomy and lymphnodes staging using DaVinci Xi
Laparoscopic surgery
Total hysterectomy with bilateral salpingo-oophorectomy and lymph nodes staging using standard laparoscopic approach

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type Measure Description Time frame Safety issue
Primary Conversion rate Number of procedures converted to laparotomy from MIS At the end of the enrollment phase
Secondary Difference in overall duration of surgery Difference in duration of procedures measured in minutes At the end of the enrollment phase
Secondary Difference in perioperative complications Number of patients with at least one perioperative complications measured by Clavien Dindo 36 and 72 months
Secondary Adherence to sentinel lymph node MSKCC algorithm Number of case with completed lymph nodal staging according to MSKCC algorithm At the end of the enrollment phase
Secondary Ergonomics of the two different surgical approach Investigators will evaluate the ergonomics of the two MIS system through the Rapid Upper Limb Assessment (RULA) assessment tool. Rula is aimed to make a rapid assessment on neck and upper limb loading in tasks. The risk of work-related disorders is calculated into a score of 1(low) to 7 (high) At the end of the enrollment phase
Secondary Quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire will be used. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure physical, social, emotional, and functional well-being in cancer patients. The score range 0-108; the higher the score, the better the QOL. 1 and 4 weeks (early), and 3 and 6 months (late) after surgery
Secondary Adherence to ESGO surgical Quality Index Investigators will assess adherence to ESGO surgical Quality Index (QI, rate of uterine rupture) 36 and 72 months
Secondary Difference in overall survival and disease-free survival Investigators will evaluate difference in Overall Survival, defined as the time between randomization and death for any cause, for alive patients OS will be censored at the date of last follow-up; investigators will evaluate difference in disease-free survival, defined as the time between randomization and the first detection of relapse or death, whichever event occurs first; for patients without events DFS will be censored at the date of last follow-up 36 and 72 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05796518 - Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors N/A
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06463028 - Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer Phase 2
Recruiting NCT06036836 - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Completed NCT03820024 - MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback N/A
Active, not recruiting NCT05082025 - Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations Phase 2
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer
Completed NCT05378152 - Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity N/A
Suspended NCT05124743 - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Recruiting NCT04569773 - Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Not yet recruiting NCT05998798 - Revealing Engagement Patterns Among Endometrial Cancer Patients
Not yet recruiting NCT06366347 - ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab Phase 2
Not yet recruiting NCT06073184 - Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium Phase 2
Terminated NCT02907073 - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter Phase 1/Phase 2
Completed NCT02549989 - Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer Phase 2