FIMBRIMENOP-2402 trial: evaluating fimbriectomy with delayed oophorectomy in patients with high-risk tubo-ovarian cancer.

BACKGROUND

Bilateral salpingo-oophorectomy is the gold-standard risk-reducing surgery for women at high risk of tubo-ovarian or primary peritoneal cancer. Fimbriectomy with delayed oophorectomy has emerged as a promising alternative, potentially reducing tubo-ovarian cancer risk while minimizing the adverse effects of premature menopause. Larger cohorts and longer follow-up are required to confirm these findings.

PRIMARY

OBJECTIVES

To evaluate the effectiveness of the chosen care pathway in controlling the risk of advanced-stage tubo-ovarian carcinoma, and more specifically to determine whether prophylactic fimbriectomy with delayed oophorectomy is non-inferior to standard bilateral salpingo-oophorectomy in women at high risk and with germline mutations.

STUDY HYPOTHESIS: Fimbriectomy with delayed oophorectomy is non-inferior to bilateral salpingo-oophorectomy in preventing oncological risk and reduces menopause-related health disorders.

TRIAL

DESIGN

This multi-center, non-randomized, pragmatic, preference-based controlled trial allows participants to choose their preventive surgical strategy between standard bilateral salpingo-oophorectomy (according to national guidelines) and fimbriectomy (considered from the age of 35, once childbearing is completed), followed by delayed oophorectomy at age 50 or at clinical menopause. Participants will undergo annual long-term follow-up until age 70. The association between the chosen care pathway and outcomes will be estimated using an inverse probability-weighted, cause-specific Cox model, with age as the time scale.

MAJOR INCLUSION/EXCLUSION CRITERIA: This study will be proposed during oncogenetic counseling to pre-menopausal women aged 30 to 50 years with a documented pathogenic germline mutation (BRCA1, BRCA2, RAD51C, RAD51D, or PALB2). Exclusion criteria include prior bilateral oophorectomy or salpingectomy and a personal history of tubo-ovarian cancer.

PRIMARY ENDPOINT: Advanced-stage tubo-ovarian or primary peritoneal carcinoma.

SAMPLE SIZE: A total of 1100 patients is planned.

ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING

RESULTS

Recruitment will last 5 years (2026-2031). The first interim analysis is planned 6 to 8 years after study initiation (2032-2034). Final analysis is planned when all patients reach age 70 (around 2071).

TRIAL REGISTRATION NUMBER: NCT06726330.