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24 Lymphadenectomy in clinically early epithelial ovarian cancer andsurvival analysis (LILAC)
  1. Seung-Hyuk Shim1,
  2. Eun Bi Jang1,
  3. Yun Jung Min1,
  4. Jung Wha Hyun1,
  5. Ji Hye Paik1,
  6. Suk Jun Chang2 and
  7. Dae-Yeon Kim3
  1. 1Konkuk University Hospital, Seoul, South Korea
  2. 2Ajou University, Suwon, South Korea
  3. 3Asan Medical Center, Seoul, South Korea


Introduction/Background The utility of lymphadenectomy in early stage EOC remains uncertain.While it may have a therapeutic role in eradicating micrometastatic lymphnodes, its diagnostic role in identifying high-risk patients is debatable. Thisstudy aims to address the ongoing clinical debate regarding thetherapeutic and diagnostic roles of systematic pelvic and para-aorticlymphadenectomy in clinically early stage epithelial ovarian cancer (EOC)patients undergoing surgery and subsequent platinum-basedchemotherapy. We hypothesize that the survival probability in patientswithout lymphadenectomy is not inferior to those with lymphadenectomy.The primary objective is to evaluate progression-free survival (PFS), whilemajor secondary objectives include assessing safety, overall survival (OS),quality of life (QoL), and exploring the association between the number ofresected lymph nodes and primary and secondary outcomes.

Methodology Eligibility: Patients aged 18–75 with presumed FIGO stages I/II high-gradeserous, high-grade endometrioid, or clear cell EOC are eligible. Exclusionsinclude low-grade mucinous histology and prior chemotherapy orradiotherapy for ovarian cancer.

Arms/Regimens: Two arms - Arm 1: Lymphadenectomy followed byplatinum-based adjuvant chemotherapy; Arm 2: No lymphadenectomyfollowed by platinum-based adjuvant chemotherapy.

Statistical Design: Primary endpoint is 3-year PFS, with secondaryendpoints including 3-year OS, QoL, number of resected lymph nodes,and surgical complications. Stratification includes surgical approach,restaging, center, and age. Sample size calculations indicate a total of 714patients, allowing for a 10% dropout rate.

Analysis Plan: Three interim safety analyses will be conducted, and theresults reviewed by the DSMB.

Results N/A.

Conclusion N/A.

Disclosures None.

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