NCT07031908

Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer

Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer, a Prospective Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In women with advanced epithelial ovarian cancer (AOC), neoadjuvant chemotherapy (NACT) combined with interval cytoreductive surgery (ICS) and post-operative chemotherapy is an option. Four randomised trials (EORTC55971, CHORUS, JCOG0602, SCORPION) have shown that survival rates after NACT are similar to those after primary cytoreductive surgery and adjuvant chemotherapy. The use of neoadjuvant chemotherapy has increased significantly in recent years, and it has been shown that the determining prognostic factor is the achievement of an absent residual tumour at surgery. However, the optimal number of neoadjuvant chemotherapy cycles is not yet well defined. Several retrospective studies have evaluated the efficacy of interval debulking surgery after performing more than 4 cycles of neoadjuvant chemotherapy. In these studies, the percentage of patients undergoing \>4 cycles of neoadjuvant chemotherapy varied in a range of approximately 22% to 45%. Currently, several randomised trials are ongoing, evaluating the optimal number of neoadjuvant chemotherapy cycles (3 vs. 6 cycles) in terms of complete cytoreduction (GOGER, NCT02125513) and survival (CHRONO, NCT03579394). Several retrospective studies have demonstrated the feasibility of minimally invasive surgery in case of a good response to neoadjuvant chemotherapy (median neoadjuvant chemotherapy cycles: 4). Therefore, a prospective randomised trial is currently underway to demonstrate the non-inferiority in terms of progression-free survival 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

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive cytoreduction	Minimally invasive cytoreduction in patients with advanced ovarian cancer treated with 6 cycles of neoadjuvant chemotherpy

Timeline

• Start date: 2025-06-15
• Primary completion: 2027-06-15
• Completion: 2029-06-15
• First posted: 2025-06-22
• Last updated: 2025-06-22

Locations

1 site across 1 country: Italy