Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE)

Area of Science:

• Gynecologic Oncology
• Surgical Oncology
• Clinical Trials

Background:

• Observational studies suggest minimally invasive interval debulking surgery (MI-IDS) is effective for advanced epithelial ovarian cancer (EOC) post-neoadjuvant chemotherapy.
• No prospective randomized data exists comparing MI-IDS to open IDS in EOC.

Purpose of the Study:

• To determine if minimally invasive surgery is non-inferior to laparotomy for disease-free survival in advanced EOC patients responding to neoadjuvant chemotherapy.
• To test the hypothesis that MI-IDS is not inferior to open IDS in this patient population.

Main Methods:

• The Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE) trial is a phase III, randomized, multicenter study.
• 549 patients with stage IIIC/IV high-grade EOC, responding to neoadjuvant chemotherapy, will be randomized to MI-IDS or open IDS.
• A pilot phase will assess feasibility, including accrual rate, crossover rate (<25%), and complete gross resection difference (<20%).

Main Results:

• Primary endpoint is non-inferiority of disease-free survival between MI-IDS and open IDS groups.
• Non-inferiority is defined by a hazard ratio margin of 1.33.

Conclusions:

• This trial aims to provide crucial prospective data on the oncologic efficacy of MI-IDS versus open IDS in advanced EOC.
• Results will inform surgical practice for well-selected patients undergoing interval debulking surgery.