Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer

NCT07031908 | Not Yet Recruiting

• 1 other identifier: 7596
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In women with advanced epithelial ovarian cancer (AOC), neoadjuvant chemotherapy (NACT) combined with interval cytoreductive surgery and post-operative chemotherapy is an option. Several retrospective studies have demonstrated the feasibility of minimally invasive surgery in case of a good response to neoadjuvant chemotherapy, and prospective randomised trial is currently underway to demonstrate the non-inferiority of minimally invasive surgery compared to laparotomy in patients with an optimal response after 3-4 cycles of neoadjuvant chemotherapy (LANCE trial, NCT04575935). The aim of our study is to evaluate the feasibility of interval surgery after at least VI cycles of neoadjuvant chemotherapy with a minimally invasive approach.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

• Feasibility of minimally invasive surgery

  Minimally invasive surgery feasibility will be calculated on the rates of: conversion from MIS to laparotomy, complete gross resection, and protocol acceptance. In this study feasibility is defined as a conversion rate \<20%, a complete gross resection rate \>80% and the enrollment of at least 1 patient each month.

  15 days

• Safety of minimally invasive surgery (First parameter)

  2 Years Overall Survival defined as the interval time (months) between surgery and death or censored at the last follow-up

  2 years

• Safety of minimally invasive surgery (Second parameter)

  2 Years Disease Free Survival defined as the interval time (months) between surgery and the first occurrence of relapse or death due to ovarian cancer, whichever occurs first or censored at the last follow-up

  2 years

• Safety of minimally invasive surgery (third parameter)

  Safety will be evaluated using the following criteria: \- Rate of early and late severe post-operative complications (early: \<30days from surgery; late: more than 30 days and less then 6 months from surgery) using Clavien Dindo classification

  6 months

Interventions

Minimally invasive cytoreduction PROCEDURE

Minimally invasive cytoreduction in patients with advanced ovarian cancer treated with 6 cycles of neoadjuvant chemotherpy

Eligibility Criteria

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

Study Population

All patients diagnosed with primary advanced epithelial ovarian cancer, FIGO stage III-IV not candidate for primary debulking surgery at diagnosis or after III-IV cycles of neoadjuvant chemotherapy.

You may qualify if:

• Stage IIIC or IV high-grade invasive epithelial ovarian carcinoma (serous, endometrioid, clear cell, transitional), primary peritoneal carcinoma, or fallopian tube carcinoma, or pathology consistent with high-grade Müllerian carcinoma.
• Partial or complete radiological response of abdominal cavity disease after at least 6 cycles of neoadjuvant chemotherapy (NACT).
• CA125 \< 100 U/mL.
• ECOG performance status 0-1.
• Signed informed consent and ability to comply with follow-up, including in cases where the patient has a legal guardian. In such cases, consent will be provided by the legal guardian.
• Review of imaging by a radiologist and senior surgeon at a multidisciplinary tumor board, particularly evaluating hepatic hilum involvement, mesenteric root, extensive peritoneal disease in the upper abdomen, extensive hepatic or gastric involvement, and extensive intestinal involvement.
• If all the previous criteria are met and protocol acceptance is obtained, the patient will undergo a laparoscopic evaluation of all abdominal quadrants to confirm the feasibility of minimally invasive surgery (MIS). Surgery will be considered feasible if complete gross resection can be achieved with minimally invasive surgery. If minimally invasive surgery is not feasible, the patient will be excluded from the study, and the reason for unfeasibility will be described.

You may not qualify if:

• Evidence of a tumor not amenable to minimally invasive complete resection on preoperative imaging (CT, PET-CT, or MRI). Radiologic criteria (tumor board evaluation): hepatic hilum involvement, mesentery root, extensive peritoneal disease in upper abdomen, extensive hepatic or gastric involvement, extensive intestinal involvement
• Disease free of other active malignancies within the past 5 years, except basal cell carcinoma of the skin.
• History of psychological, familial, sociological, or geographic conditions potentially impeding adherence to the study protocol and follow-up program
• Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Carmine Conte

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmine Conte

CONTACT

+39 063015 5878; carmine.conte@policlinicogemelli.it

Study Design

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

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2029
• Last Updated: June 22, 2025

Record last verified: 2025-05

Locations

IT (1)