ROSE Trial

A Phase III Randomized Trial of Systematic Lymphadenectomy in Patients with Apparent Early-Stage High-Grade Epithelial Ovarian Cancer

Background

Systematic lymphadenectomy in early-stage epithelial ovarian cancer remains controversial, with unclear survival benefit despite increased surgical morbidity. The ROSE trial evaluates whether omission of lymphadenectomy is non-inferior in terms of disease-free survival.

Objectives

Primary: Compare disease-free survival (DFS)

Secondary:

• Overall survival
• Pattern of recurrence
• Perioperative outcomes
• Adverse events
• Quality of life (FACT-O)
• Patient-reported outcomes

Study Design

• Phase III, multicentre randomized trial
• 1:1 allocation
• Open-label design

Sample Size

A total of 1,000 patients will be enrolled to detect non-inferiority with 80% power and a one-sided alpha of 0.025.

Contact

Principal Investigator: Dr. Jagannath Mishra
Tata Medical Centre, Kolkata
Email: your@email.com, alternate email: your@email.com